Notes

PROLOGUE

after completing eighty-one inspections: FDA, Establishment Inspection Report, Wockhardt Ltd., Aurangabad, India, March 18–22, 2013. A full list of Peter Baker’s inspections, and those of all FDA investigators, can be found on the website https://fdazilla.com/.

than it did within U.S. borders: The figures related to the growth of imported drugs and overseas drug plants come from Pew Charitable Trust, Pew Health Group, “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” July 12, 2011, 22.

about a quarter of U.S. patients: Ketaki Gokhale, “Urine Spills Staining Image of Wockhardt’s Generic Drugs,” Bloomberg, September 27, 2013.

was walking toward him just a little too quickly: Documents that helped to re-create this scene include: FDA, Form 483, Inspectional Observations, Wockhardt Ltd., Aurangabad, India, March 18–22, 2013; FDA, Establishment Inspection Report, Wockhardt Ltd., Aurangabad, India, March 18–22, 2013; FDA, Warning Letter (WL: 320-13-21), July 18, 2013; news stories, including Pallavi Ail, “USFDA Says Team Threatened during Wockhardt Inspection,” Financial Express, May 28, 2014.

contained black particles: FDA, Establishment Inspection Report, 13–18.

restricted the import of drugs: Reuters, May 23, 2013. Accessed December 14, 2018. https://in.reuters.com/article/wockhardt-fda-revenue-loss/wockhardt-hit-by-fda-import-alert-on-drug-plant-idINDEE94M09320130523.

“in a month or two months maximum”: Wockhardt Ltd. did not respond to repeated emails and phone calls seeking comment. However, after the FDA issued its import alert, Wockhardt CEO Habil Khorakiwala held an emergency conference call on May 24, 2013. During the call, he sought to reassure investors that the company was working to satisfy the FDA’s concerns and planned to hire a U.S. consultant to help bring “this facility into compliance in a month or two months maximum.” When pressed by an investor, Khorakiwala said that the reason the FDA found so many lapses in Waluj was because the bulk of products manufactured at one facility there were destined for non-U.S. markets. The FDA wound up inspecting this facility, which wasn’t explicitly set up to meet rigorous U.S. standards. Habil Khorakiwala, “Wockhardt Conference Call to Discuss U.S. FDA Report on Waluj Facility,” May 24, 2013, http://www.wockhardt.com/pdfs/Wockhardt-Investor-Call-USFDA-Import-Alert-version-final.pdf (accessed December 3, 2018).

CHAPTER 1: THE MAN WHO SAW FURTHER

Bristol-Myers Squibb’s research and development center: This description of the campus comes from a reporting trip there in November 2015.

In 2001, it was on track to clock: Detailed information regarding Ranbaxy and the development of its business in the United States can be found in: Bhupesh Bhandari, The Ranbaxy Story: The Rise of an Indian Multinational (Delhi: Penguin Books India, 2005); Legends Are Forever: The Story of Ranbaxy (Ranbaxy Global Corporate Communications, 2015); P. Indu, Ranbaxy’s Globalization Strategies and Its Foray into the U.S. (ICMR Center for Management Research, 2005).

The FDA had already approved over a dozen: By 2001, the FDA had approved seventeen of Ranbaxy’s drug applications, as listed in Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs).

comprised half of the U.S. drug supply: Ann M. Thayer, “30 Years of Generics,” Chemical and Engineering News, September 29, 2014.

a doorstop of a master’s thesis: P. T. Vasudevan and D. S. Thakur, “Soluble and Immobilized Catalase,” Applied Biochemistry and Biotechnology, 49, no. 3 (1994): 173–89, doi:10.1007/bf02783056.

CHAPTER 2: THE GOLD RUSH

what would become an Abbreviated New Drug Application or ANDA: U.S. Department of Health and Human Services, Food and Drug Administration, “Abbreviated New Drug Application (ANDA),” updated May 17, 2018, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm (accessed January 10, 2018).

first $10-billion-a-year drug: John Simons, “The $10 Billion Pill,” Fortune, January 20, 2003; Katherine Eban, “The War over Lipitor,” Fortune, May 6, 2011.

the final submission was ready: Keith Webber, FDA CDER, letter to Scott D. Tomsky, Ranbaxy, November 30, 2011.

“RECEIVED: August 19, 2002”: Abha Pant, Ranbaxy Laboratories Ltd., letter to Office of Generic Drugs, August 19, 2002, vi.

Abbreviated New Drug Application 76-477: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Approval Package for Application Number: ANDA 076477Orig1s000, November 30, 2011, https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076477Orig1s000.pdf (accessed May 24, 2018).

Lipitor is as moody as the slate-gray landscape: This description of Pfizer’s Ringaskiddy plant comes from a reporting trip there in August 2014.

the battle that lay ahead: A record of the litigation between Pfizer and Ranbaxy can be found at Pfizer Inc. et al. v. Ranbaxy Laboratories Ltd., et al. (U.S. District Court for the District of Delaware, August 2, 2006), Pacer Case Locator Case 06-1179, https://ecf.ded.uscourts.gov/cgi-bin/HistDocQry.pl?363128528119674-L_1_0-1 (accessed May 23, 2018).

a CNN business reporter assessed it as: Aaron Smith, “Investors Biting Nails over Lipitor,” CNN Money, August 2, 2005.

“extra gland that produces publicity”: Nora Ephron, “Oh Haddad, Poor Haddad,” New York, November 25, 1968.

Touting the benefits of lower-cost drugs: Ronald Reagan, “Remarks on Signing the Drug Price Competition and Patent Term Restoration Act of 1984,” September 24, 1984, Reagan Library, https://www.reaganlibrary.gov/research/speeches/92484b.

“a place where you put raw materials into a mixing vat”: This quote attributed to Seife comes from Herbert Burkholz, The FDA Follies (New York: Basic Books, 1994), 26. In an endnote, Burkholz attributes it to the personal communication of David W. Nelson, former chief investigator for the House Subcommittee on Oversight and Investigations for the Committee on Energy and Commerce (personal communication).

On the cold, clear night: An account of the competition for Provigil and the waiting in the FDA parking lot appears in the lawsuit Federal Trade Commission v. Cephalon, Inc., Civil Action No. 2:08-cv-2141-MSG (U.S. District Court for the Eastern District of Pennsylvania, August 12, 2009), www.ftc.gov, https://www.ftc.gov/sites/default/files/documents/cases/2009/08/090812cephaloncmpt.pdf (accessed June 15, 2018).

In written guidance to the industry: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, “Guidance for Industry: 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day,” July 2003, 4.

As one of Ranbaxy’s CEOs, Davinder Singh Brar, explained: Legends Are Forever, 54.

In May 2003, Ranbaxy’s top executives: Several documents helped to re-create this scene. Rajiv Malik described the events in Boca Raton to FDA criminal investigators during the Ranbaxy investigation. They detailed his statements, which he made on February 26, 2010, in Rajiv Malik, “Memorandum of Interview,” Food and Drug Administration, Office of Criminal Investigations, February 26, 2010. Ranbaxy officials summarized the results of their Sotret tests in a four-page document entitled “Sotret-Investigation Report.”

had killed himself while taking it: Jennifer Frey, “A Double Dose of Heartache,” Washington Post, January 10, 2001. Frey chronicles the suicide of BJ, the son of Representative Bart Stupak, a Democrat from Michigan.

CHAPTER 3: A SLUM FOR THE RICH

shopping malls, followed: This description is supported by 2011 census data released by the Directorate of Census Operations in Haryana (accessed December 20, 2017) and multiple news articles, including Vidhi Doshi, “Gurgaon: What Life Is Like in the Indian City Built by Private Companies,” Guardian, July 4, 2016.

Donkeys and pigs wandered: Some observations of Gurgaon, the Mehrauli-Gurgaon road, Ranbaxy Laboratories, and Dinesh Thakur’s first home in Phase 1 of Gurgaon come from a reporting trip made in January 2015.

Instead, the BBC suggested: Shalu Yadav, “India’s Millennium City Gurgaon a ‘Slum for the Rich’?” BBC Hindi, August 17, 2012.

The Indian press had dubbed Parvinder: “Cover Story: India’s Best Managed Company,” Business Today, March 13, 2005.

He declared to adoring throngs: Celia W. Dugger, “Whatever Happened to Bill Clinton? He’s Playing India,” New York Times, April 5, 2001.

Even in Africa, their drugs: Legends Are Forever, 46.

at almost two dollars a pill: Shankar Vedantam and Terence Chea, “Drug Firm Plays Defense in Anthrax Scare,” Washington Post, October 20, 2001.

was one-fifth that: Manu Joseph, “Indian Cipro Copies Don’t Pay Off,” Wired, November 8, 2001.

“It’s very important to give these companies”: Biman Mukherji, “No AIDS Progress without Affordable Medicine, Clinton Says in India,” Agence France-Presse, November 21, 2003.

As Ranbaxy’s next managing director, Dr. Brian Tempest: Randeep Ramesh, “Benign Buccaneer: Interview Brian Tempest, Chief Executive Designate of Ranbaxy,” Guardian, March 27, 2004.

“Our humanitarian effort has been”: Rohit Deshpande, Sandra J. Sucher, and Laura Winig, “Cipla 2011,” Case Study N9-511-050, Harvard Business School, May 3, 2011.

the electric bus stalled: “Indian Officials Red-Faced after Clinton’s Taj Mahal Bus Breaks Down,” Agence France Presse, November 23, 2003.

CHAPTER 4: THE LANGUAGE OF QUALITY

“Hazard Analysis Critical Control Point”: The CFR Title 21 covering food and drugs can be found on the FDA website, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (accessed June 15, 2018).

a pan on the stove with pieces of meat in it—dog meat: This scene was re-created based on interviews and secondary sources. I requested primary inspection documents from the FDA under the Freedom of Information Act, but all documents related to Hernandez’s inspection, the FDA explained, including the FDA Form 483, had been destroyed in Hurricane Katrina in 2005.

his inspection at the Sherman Pharmaceuticals plant in Abita Springs: The FDA purged records of the 1994 Sherman Pharmaceuticals inspection in accordance with its documentation retention schedule, according to a Freedom of Information Act request for the Establishment Inspection Report and subsequent Form 483 related to this inspection. Thus, I’ve re-created scenes based on interviews and secondary sources. Sherman Pharmaceuticals also appears on a list of companies found to be in violation of the FDA’s Application Integrity Policy; see U.S. Food and Drug Administration, “Application Integrity Policy—Application Integrity Policy List,” updated October 7, 2011, https://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134453.htm (accessed June 19, 2018).

debut in a 1962 amendment: Garnet E. Peck, “Historical Perspective,” Food Drug Cosmetic Journal, August 1979.

laid out seven rules: Mona Nasser et al., “Ibn Sina’s Canon of Medicine: 11th Century Rules for Assessing the Effects of Drugs,” Journal of the Royal Society of Medicine 102, no. 2 (2009): 78–80, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2642865/ (accessed December 28, 2017).

the Assize of Bread: Peter Cartwright, Consumer Protection and the Criminal Law: Law, Theory, and Policy in the U.K. (Cambridge: Cambridge University Press, 2001), 152, http://assets.cambridge.org/97805215/90808/frontmatter/9780521590808_frontmatter.pdf (accessed December 28, 2017).

known as pharmacopoeias: Lembit Rägo and Budiono Santoso, “Drug Regulation: History, Present and Future,” in Drug Benefits and Risks: International Textbook of Clinical Pharmacology, 2nd ed., rev., edited by C. J. von Boxtel, B. Santoso, and I. R. Edwards (Amsterdam: IOS Press and Uppsala Monitoring Centre, 2008), 65–77, http://www.who.int/medicines/technical_briefing/tbs/Drug_Regulation_History_Present_Future.pdf (accessed December 28, 2017).

was meant to rid the country: The Authority of the Medical Societies and Colleges, Pharmacopoeia of the United States of America (Boston: Wells and Lilly, for Charles Ewer, 1820). See also Jeremy A. Greene, Generic: The Unbranding of Modern Medicine (Baltimore: Johns Hopkins University Press, 2014), 27.

published a controversial book: Friedrich Christian Accum, A Treatise on Adulterations of Food, and Culinary Poisons. Exhibiting the Fraudulent Sophistications of Bread, Beer, Wine, Spiritous Liquors, Tea, Coffee, Cream, Confectionery, Vinegar, Mustard, Pepper, Cheese, Olive Oil, Pickles, and Other Articles Employed in Domestic Economy. And Methods of Detecting Them (London: printed by J. Mallett, sold by Longman, Hurst, Rees, Orme, and Brown, 1820), https://trove.nla.gov.au/work/19480247?selectedversion=NBD4018878 (accessed December 28, 2017).

square-jawed, meticulous doctor: Dale A. Stirling, “Harvey W. Wiley,” Toxicological Sciences 67, no. 2 (June 1, 2002): 157–58, https://academic.oup.com/toxsci/article/67/2/157/1635211 (accessed December 28, 2017).

“hygienic table trials”: National Endowment for the Humanities, Chronicling America, “The Washington Times, December 14, 1902, Page 14, Image 14,” https://chroniclingamerica.loc.gov/lccn/sn84026749/1902-12-14/ed-1/seq-14/ (accessed December 28, 2017).

an epidemic of diphtheria: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Communication, Training, and Manufacturers Assistance, “The St. Louis Tragedy and Enactment of the 1902 Biologics Control Act,” Commemorating 100 Years of Biologics Regulation.

throat contorted in painful spasms: Paul A. Offit, The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis (New Haven, CT: Yale University Press, 2007), 58.

as being worthless and deadly: Samuel Hopkins Adams, “The Great American Fraud,” Collier’s Weekly, October 7, 1905, https://books.google.com/books?id=fd_S2Van52EC&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=false (accessed December 28, 2017).

exhibition of hazardous food: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, “The American Chamber of Horrors,” Histories of Product Regulation.

107 people, many of them children: Carol Ballentine, “Sulfanilamide Disaster,” FDA Consumer, June 1981.

nearly three hundred people fell into comas: John P. Swann, “The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices,” PDA Journal of Pharmaceutical Science and Technology 53, no. 3 (May/June 1999): 148–53, https://www.ncbi.nlm.nih.gov/pubmed/10754705 (accessed December 28, 2017).

what a good control system should be: Dale E. Cooper, “Adequate Controls for New Drugs,” Pharmacy in History 44, no. 1 (2002); John P. Swann, “The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices,” Pharmacy in History 40, no. 1 (1999).

to sell a drug called Kevadon: Linda Bren, “Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History,” U.S. Food and Drug Administration, FDA Consumer (March/April 2001), http://web.archive.org/web/20061020043712/http:/www.fda.gov/fdac/features/2001/201_kelsey.html (accessed December 28, 2017).

known as the Kefauver-Harris Amendment: Cornelius D. Crowley, “Current Good Manufacturing Practices,” Food and Drug Law Journal (March 1996).

the amendment redefined what it meant: Cooper, “Adequate Controls for New Drugs.”

master formula and documentation: Federal Register (June 20, 1963): 6385–87.

the agency undertook a major survey: Seymore B. Jeffries, “Current Good Manufacturing Practices Compliance—A Review of the Problems and an Approach to Their Management,” Food and Drug Law Journal (December 1968).

sites regulated by the FDA exceeded those in the United States: Pew Charitable Trust, Pew Health Group, “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” July 12, 2011.

advance notice became the jury-rigged solution: In response to written questions, the FDA stated, “There are many reasons that FDA inspections are preannounced such as ensuring that the appropriate personnel from the inspected firm are available during the inspection.”

CHAPTER 5: RED FLAGS

echoed in a management review: Christopher King, “Management Development Report: Dinesh Thakur,” Kelly & King, August 3, 2004.

report from the World Health Organization: World Health Organization, “Inspection Report,” Vimta Labs, Hyderabad, India, July 26–27, 2004.

CHAPTER 6: FREEDOM FIGHTERS

He left school and went to Sabarmati: Many of the details from Dr. K. A. Hamied’s life are drawn from his autobiography, K. A. Hamied, A Life to Remember (Bombay: Lalvani Publishing House, 1972).

“His words were law unto us”: K. A. Hamied, “Oral History Reminisces of India’s History Freedom Struggle from 1913 Onwards,” interview by Uma Shanker, Centre of South Asian Studies, January 13, 1970.

Gandhi urged Hamied to step into this void: Peter Church, Added Value: 30 of India’s Top Business Leaders Share Their Inspirational Life Stories (New Delhi: Roli Books Pvt., 2010), 85.

enabled him to lease a palatial apartment: Hamied, A Life to Remember, 111.

In 1953, he was appointed sheriff of Bombay: Ibid., 240.

India followed the outdated British patent laws of 1911: Y. K. Hamied, “Indian Pharma Industry: Decades of Struggle and Achievement,” address on the occasion of Dr. A. V. Rama Rao’s seventieth birthday, Hyderabad, April 2, 2005.

Prime Minister Indira Gandhi was highly sympathetic: Deshpande, Sucher, and Winig, “Cipla 2011,” 2.

The 1970 Indian Patents Act: Ibid.

Few got better results than Bhai Mohan Singh: The history of Bhai Mohan Singh and Ranbaxy’s early days is drawn from Bhandari, The Ranbaxy Story; and Legends Are Forever.

Bhai Traders and Financiers Pvt. Ltd.: Bhandari, The Ranbaxy Story, 29.

His cousins Ranjit and Gurbax: Ibid.

When his alliance with an Italian drug company: Ibid., 40.

launched a generic version of Roche’s Valium: Ibid., 47.

The dean there had written to Bhai Mohan: Ibid., 51.

the company held a prayer ceremony with sixteen local monks: Legends Are Forever, 52.

In 1987, two Ranbaxy executives traveled: Ibid., 45.

Varis was a firebrand: Margalit Fox, “Agnes Varis, 81, Founder of Drug Company,” New York Times, August 3, 2011.

In 1989, at age seventy-one: Bhandari, The Ranbaxy Story, 90.

As the businesses inherited by the younger sons foundered: For a fuller account of the Singh family rivalries, see ibid., 90–107. See also Shyamal Majudal, “The Ranbaxy Clash,” in Majudal, Business Battles: Family Feuds That Changed Indian Industry (New Delhi: Business Standard Books, 2014).

“chili up my back every day”: Bhandari, The Ranbaxy Story, 111.

“liaison managers between the government and industrialists”: See Majudal, “The Ranbaxy Clash.”

Dozens of warring executives: Bhandari, The Ranbaxy Story, 143–51.

CHAPTER 7: ONE DOLLAR A DAY

annual subscription budget that topped $150,000: Donald G. McNeil Jr., “Selling Cheap ‘Generic’ Drugs, India’s Copycats Irk Industry,” New York Times, December 1, 2000.

“What is AIDS?”: There are numerous accounts of Dr. Yusuf Hamied’s efforts to combat the AIDS epidemic. Some helpful accounts include Michael Specter, “India’s Plague: Are Cheap Drugs Really the Answer to AIDS?” The New Yorker, December 17, 2001; Fire in the Blood: Medicine, Monopoly, Malice, documentary film directed by Dylan Mohan Gray, 2013.

Just five years earlier, in 1981: Deshpande, Sucher, and Winig, “Cipla 2011,” exhibit 1, AIDS timelines.

But it was brewing so forcefully: Bob Drogin, “Bombay: Epicenter of Disaster,” Los Angeles Times, November 26, 1992.

AIDS was destroying Africa: Mark Schoofs, “The Agony of Africa,” Village Voice, November/December 1999, http://www.pulitzer.org/winners/mark-schoofs (accessed May 25, 2018). See also UNAIDS Joint United Nations Programme on HIV/AIDS, “AIDS Epidemic Update: December 1998,” December 1998, http://data.unaids.org/publications/irc-pub06/epiupdate98_en.pdf (accessed December 8, 2018).

biggest industry was making wooden coffins: Neil Darbyshire, “Land Where Only Coffin Makers Thrive,” Telegraph, June 24, 2002.

90 million Africans by 2025: Joint United Nations Programme on HIV/AIDS (UNAIDS), AIDS in Africa: Three Scenarios to 2025, January 2005, http://www.unaids.org/sites/default/files/media_asset/jc1058-aidsinafrica_en_1.pdf (accessed December 8, 2018).

In 1991, Dr. Rama Rao: Peter Church, Added Value: 30 of India’s Top Business Leaders Share Their Inspirational Life Stories (New Delhi: Roli Books Pvt., 2010), 92.

In 1997, under the leadership of Nelson Mandela: Helene Cooper, Rachel Zimmerman, and Laurie McGinley, “AIDS Epidemic Puts Drug Firms in a Vise: Treatment vs. Profits,” Wall Street Journal, March 2, 2001, https://www.wsj.com/articles/SB983487988418159849 (accessed May 25, 2018); see also Deshpande, Sucher, and Winig, “Cipla 2011,” 5.

On September 28, 2000, he took to the podium: Y. K. Hamied, speech at the Round Table Conference, European Commission, Brussels, September 28, 2000. This scene is also recounted in Specter, “India’s Plague.”

The resulting article, a detailed profile: McNeil, “Selling Cheap ‘Generic’ Drugs, India’s Copycats Irk Industry.”

one of the most devastating earthquakes ever: R. Bendick et al., “The 26 January 2001 ‘Republic Day’ Earthquake, India,” Seismological Research Letters 72, no. 3 (May/June 2001): 328–35, doi:10.1785/gssrl.72.3.328 (accessed June 15, 2018).

Bill Clinton, who’d just left office: David Remnick, “The Wanderer: Bill Clinton’s Quest to Save the World, Reclaim His Legacy—and Elect His Wife,” The New Yorker, September 18, 2006.

McNeil’s story was published the next morning: Donald G. McNeil Jr., “Indian Company Offers to Supply AIDS Drugs at Low Cost in Africa,” New York Times, February 7, 2001.

As the Wall Street Journal summed it up: Cooper, Zimmerman, and McGinley, “AIDS Epidemic Puts Drug Firms in a Vise.”

“They are pirates”: Neelam Raj, “Cipla: Patients before Patents,” in The Politics of the Pharmaceutical Industry and Access to Medicines, edited by Hans Löfgren (New York: Routledge/Social Science Press, 2018).

“Of course I have an ulterior motive”: Deshpande, Sucher, and Winig, “Cipla 2011,” 6.

people rallied against the drug companies all over the world: Adele Baleta, “Drug Firms Take South Africa’s Government to Court,” The Lancet 357, no. 9258 (March 10, 2001), doi:10.1016/S0140-6736(00)04158-1 (accessed June 15, 2018).

The Clinton Foundation stepped in: Celia W. Dugger, “Clinton Makes Up for Lost Time in Battling AIDS,” New York Times, August 29, 2006, https://www.nytimes.com/2006/08/29/health/29clinton.html (accessed June 15, 2018).

But on January 28, 2003, he stunned them: Ethan B. Kapstein and Joshua W. Busby, AIDS Drugs for All: Social Movements and Market Transformations (Cambridge: Cambridge University Press, 2013), 138.

Randall Tobias, the former CEO: John W. Dietrich, “The Politics of PEPFAR: The President’s Emergency Plan for AIDS Relief,” Ethics and International Affairs 21, no. 3 (Fall 2007): 277–93.

In March 2004, six senators: Senators John McCain, Russell D. Feingold, Ted Kennedy, Lincoln Chafee, Olympia Snowe, and Dick Durbin, letter to the Honorable George W. Bush, March 26, 2004.

first Indian generics company to get approval from the PEPFAR program: “Appendix VI: Generic HIV/AIDS Formulations Made Eligible for Purchase by PEPFAR Programs under the HHS/FDA Expedited Review Process, through December 10, 2006,” United States President’s Emergency Plan for AIDS Relief, 2006, https://www.pepfar.gov/press/82131.htm (accessed June 21, 2018); The Power of Partnerships: The United States President’s Emergency Plan for AIDS Relief: Third Annual Report to Congress on PEPFAR, 2007, https://www.pepfar.gov/documents/organization/81019.pdf (accessed June 19, 2018).

CHAPTER 8: A CLEVER WAY OF DOING THINGS

He submitted his resignation: Rajiv Malik, “Memorandum of Interview,” Food and Drug Administration, Office of Criminal Investigations, February 26, 2010. The MOI states, “He explained that he drafted his resignation letter on the plane to India after the Boca Raton meeting. Malik submitted his resignation on June 1, 2003 but stayed on for approximately another two months.”

in June 2003: According to the MOI, Malik and his Ranbaxy team were hired by the generic drug company Sandoz, in Vienna, where they stayed for two years.

advanced a theory: Dr. Raghunath Anant Mashelkar served as director-general of India’s Council of Scientific and Industrial Research. He outlined his concept of Gandhian innovation in an influential article, R. A. Mashelkar and C. K. Prahalad, “Innovation’s Holy Grail,” Harvard Business Review (July/August 2010), https://hbr.org/2010/07/innovations-holy-grail (accessed January 10, 2018).

It could often mean “better”: Some of India’s leading generic drug manufacturers have argued that they could make superior drugs but are restricted by regulations that require their products to be similar to the brand. At Cipla, Dr. Yusuf Hamied explained that though his chemists were the best in the world, “I have to be as bad as the original,” he said.

In 1961, two army vets: The account of Mylan’s early history comes from John T. Seaman and John T. Landry, Mylan: 50 Years of Unconventional Success: Making Quality Medicine Affordable and Accessible (Canonsburg, PA: Mylan, 2011).

“white as ever”: Ibid., 65.

“Bresch and Coury saw”: Ibid., 114.

resort to “shenanigans”: Carolyn Y. Johnson, “FDA Shames Drug Companies Suspected of Abusive Tactics to Slow Competition,” Washington Post, May 18, 2018, http://www.highbeam.com/doc/1P4-2040528829.html?refid=easy_hf (accessed November 12, 2018).

The results yield a graph that contains: Sam H. Haidar, Barbara Davit, Mei-Ling Chen, Dale Conner, Laiming Lee, Qian H. Li, Robert Lionberger, Fairouz Makhlouf, Devvrat Patel, Donald J. Schuirmann, and Lawrence X. Yu, “Bioequivalence Approaches for Highly Variable Drugs and Drug Products,” Pharmaceutical Research 25, no. 1 (2007): 237–41, doi:10.1007/s11095-007-9434-x. For more details of the FDA’s bioequivalence standards, see also “Preface,” in Orange Book; Lynda S. Welage, Duane M. Kirking, Frank J. Ascione, and Caroline A. Gaither, “Understanding the Scientific Issues Embedded in the Generic Drug Approval Process,” Journal of the American Pharmaceutical Association 41, no. 6 (2001): 856–67, doi:10.1016/s1086-5802(16)31327-4.

So, in 1992: The FDA published a guidance in July 1992 that outlined the central concepts of bioequivalence: “Statistical Procedures for Bioequivalence Studies Using a Standard Two Treatment Cross-over Design” (Washington, DC: FDA, Center for Drug Evaluation and Research, 1992). That guidance recommended a statistical analysis for pharmacokinetic measures, including AUC and Cmax. It proposed a calculation of a 90 percent confidence interval for the ratio of averages, and a requirement that this confidence interval fall within a range of 80 to 125 percent bioequivalence. The FDA deemed this approach “average bioequivalence.” However, the debate over bioequivalence wasn’t put to rest with the 1992 guidance, as documented in Robert Schall’s “Bioequivalence: Tried and Tested” (Cardiovascular Journal of Africa 21, no. 2 [April 2010]: 69–70), because, at the same time the FDA issued its guidance, the biostatisticians Sharon Anderson and Walter W. Hauk raised a new question about whether drugs deemed “bioequivalent” work the same way in different patients, with implications for patients switching from one drug to another. This concept, dubbed “individual bioequivalence,” became a new area of research and debate. Yet there was doubt about whether the new concept of individual bioequivalence was a legitimate concern or an unnecessary precaution. According to Schall and other critics, the FDA essentially ignored the concept in its 2003 guidance, which instead reiterated the 1992 definition of average bioequivalence; see “Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products: General Considerations” (Washington DC: FDA, Center for Drug Evaluation and Research, March 2003).

Johnson & Johnson’s epilepsy drug: Natasha Singer, “J&J Unit Recalls Epilepsy Drug,” New York Times, April 14, 2011, https://prescriptions.blogs.nytimes.com/2011/04/14/j-j-unit-recalls-epilepsy-drug/ (accessed July 16, 2018).

the number of drug applications: Seaman and Landry, Mylan, 121.

CHAPTER 9: THE ASSIGNMENT

“Everyone knows,” he said, by way of greeting: The details of Dinesh Thakur’s interaction with Arun Kumar come, in part, from an account that Dinesh Thakur drafted, starting one year after he left Ranbaxy. Reached in May 2013, Arun Kumar denied that he shared information with Thakur and claimed instead that he shared it with the company. He asserted that management launched an investigation because it didn’t know about the misconduct. He did not respond to more recent attempts to contact him. Thakur’s account of Arun Kumar sharing information for his review and working on his report is corroborated by an interview that Dr. Raj Kumar gave to FDA criminal investigators in which he told them: “Kumar asked the Director of Regulatory Affairs, Arun Kumar if there was exposure on other Ranbaxy products in addition to the ARVs and without hesitation Kumar responded, ‘Yes.’ Kumar instructed Arun Kumar and Thakur to provide a risk assessment and a summary of what the problematic issues were with Ranbaxy ARV products.” Rajinder Kumar, “Food and Drug Administration Office of Criminal Investigations, Memorandum of Interview,” April 10, 2007.

by concealing unsold inventory: “Ex-Bristol-Myers Execs Plead Not Guilty,” Associated Press, June 22, 2005. Prosecutors dropped the criminal case against the two men after an April 2010 court decision restricted the testimony of an expert witness. The case ended in 2012 when the men reached a settlement with the U.S. Securities and Exchange Commission. Richard Vanderford, “Ex-Bristol Myers Exec Settles SEC Profit Inflation Suit,” Law 360, April 2, 2012.

Kumar distributed a spreadsheet: The ten-page spreadsheet prepared by Dinesh Thakur came to be known as the Ranbaxy issues portfolio.

Kumar showed the men a PowerPoint of twenty-four slides: The PowerPoint presentation of October 14, 2004, prepared by Dinesh Thakur and shown to a board subcommittee by Raj Kumar, came to be known by Ranbaxy executives as the Self-Assessment Report or “SAR.” It also appeared in a PowerPoint presentation associated with United States v. Ranbaxy, shown by prosecutors to Ranbaxy lawyers on November 17, 2009. Dr. Kumar also described to FDA criminal investigators what occurred in the boardroom in Rajinder Kumar, “Food and Drug Administration Office of Criminal Investigations, Memorandum of Interview,” April 10, 2007.

broken down piece by piece: Rajinder Kumar’s memorandum of the interview states: “Tempest directed all who had a copy of the presentation to destroy it. He also directed that the computer used to generate the presentation be destroyed.”

CHAPTER 10: THE GLOBAL COVER-UP

They were determined to make the most of the soggy event: Ramesh Adige, “Clinton Library Dedication,” Ranbaxy World: A Bi-Annual External Newsletter of Ranbaxy (August 2005): 9. Donation amounts are taken from the Clinton Foundation’s website, where they are listed as a range; see https://www.clintonfoundation.org/contributors.

the company had big future plans: Ranbaxy World, 2, 18.

President of Pharmaceuticals Malvinder Singh: Amberish K. Diwanji (deputy managing editor), “The Rediff Interview/Malvinder Singh, President, Ranbaxy,” Rediff, November 25, 2004, http://www.rediff.com/money/2004/nov/25inter.htm (accessed May 29, 2018).

“ever-decreasing resources”: Food and Drug Administration, “Drug Manufacturing Inspections Program (Foreign CGMP Pilot Protocol),” compliance program circular, October 1, 2006.

becoming the bulk-drug capital of India: Raksha Kumar, “Planned ‘Pharma City’ to Pump Out Cheap Indian Drugs Is Making Indian Villagers Sick with Anger,” South China Morning Post, February 17, 2018, https://www.scmp.com/week-asia/business/article/2133347/planned-pharma-city-pump-out-cheap-indian-drugs-making-villagers (accessed September 21, 2018).

a report by the U.S. Government Accountability Office: U.S. Government Accountability Office, “Food and Drug Administration: Improvements Needed in the Foreign Drug Inspection Program,” GAO/HEHS-98-21 (Washington, DC: GAO, March 17, 1988).

In his summary of the inspection: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories Ltd., Paonta Sahib, India, December 17–21, 2004.

Gavini must have walked directly past: Stein Mitchell & Muse LLP, “Unregistered Use of 4°C Refrigerators to Conceal Drug Defects,” February 21, 2011. This report, prepared by lawyers for Dinesh Thakur during the Ranbaxy case, notes: “In 2004, PSCWICO1, an 1800 liter ThermoLab stability refrigerator, was purchased in February 2004, was installed on May 1, 2004, and became operational on May 5, 2004.”

CHAPTER 11: MAP OF THE WORLD

His old boss, Barbhaiya, had been given: Rajinder Kumar, “Food and Drug Administration Office of Criminal Investigations, Memorandum of Interview,” April 10, 2007. In this interview with Dr. Kumar, FDA investigators noted: “Tempest told Kumar that Barbhaiya threatened that he would go public with information regarding fraudulent practices at Ranbaxy and received over one million dollars as a compensation package.”

Just eighteen months earlier, a project director: V. K. Raghunathan, “Indian Engineer Killed for Exposing Graft,” Straits Times, December 12, 2003.

“Ranbaxy Laboratories in India is fooling you”: “Malvinder Singh,” “PEPFAR & ARVs,” email to Randall Tobias, Mark Dybul, and Adriaan J. Van Zyl, August 15, 2005.

So he wrote again, this time more pointedly: “Malvinder Singh,” “Fwd: Pepfar & ARVs,” email to Gary Buehler, Jane Axelrad, David Horowitz, Joseph Famulare, Steven Galson, Warren Rumble, and Robert West, August 17, 2005.

In a forceful and urgent email: “Malvinder Singh,” “Re: Fwd: PEPFAR & ARVs,” email to FDA commissioner Lester Crawford, August 29, 2005.

In an email afterward: “Malvinder Singh,” “RE: PEPFAR & ARVs,” email to Edwin Rivera-Martinez, September 9, 2005.

The five-page assignment memo: U.S. Department of Health and Human Services, Food and Drug Administration, Branch Chief, Investigations and Preapproval Compliance Branch, HFD-322, “Request for ‘For Cause’ Investigation FACTS #678634,” memorandum sent to Director, Division of Field Investigations, HFC-130, October 7, 2005.

CHAPTER 12: THE PHARAOH OF PHARMA

His father, Parvinder, had been austere: Descriptions of Malvinder Mohan Singh’s childhood, as well as his family’s history, were drawn from Bhandari, The Ranbaxy Story.

His management style was brash: Depictions of Malvinder Mohan Singh’s management style, lifestyle, and personal tastes are drawn from numerous articles about him and his brother in the Indian media, including: “The Rediff Interview/Malvinder Singh, President, Ranbaxy”; Archna Shukla, “Ranbaxy Revs Up,” Business Today, September 10, 2006, http://archives.digitaltoday.in/businesstoday/20060910/cover1.html (accessed June 8, 2018); Moinak Mitra and Bhanu Pande, “Ranbaxy’s Singhs Ready to Build Empire,” Economic Times, April 17, 2009, https://economictimes.indiatimes.com/magazines/corporate-dossier/ranbaxys-singhs-ready-to-build-empire/articleshow/4412356.cms (accessed June 8, 2018).

dubbed him “the Pharaoh of Pharma”: Joe Mathew, “Newsmaker: Malvinder Mohan Singh: Pharaoh of Pharma,” Business Standard, January 12, 2007, https://www.business-standard.com/article/beyond-business/newsmaker-malvinder-mohan-singh-107011201042_1.html (accessed June 6, 2018).

to nineteenth in 2005: Naazneen Karmali, “India’s 40 Richest,” Forbes, December 10, 2004, https://www.forbes.com/2004/12/08/04indialand.html#629040502bae (accessed June 15, 2018); Naazneen Karmali, “India’s 40 Richest,” Forbes, December 15, 2005, https://www.forbes.com/2005/12/15/india-richest-40_05india_land.html#5fa54b954faf (accessed June 15, 2018).

“I want profit!”: Katherine Eban, “Dirty Medicine,” Fortune, May 15, 2013.

$100,000 champagne-colored Mercedes: Archna Shukla, “Cars the Super Rich Drive,” Business Today, October 22, 2006.

in an interview for Duke University’s business school alumni magazine: John Manuel, “Singhing the Same Tune,” Exchange (Summer 2001): 34–35.

manufacturing plant in the northern state of Himachal Pradesh: A full list of inspections conducted at Paonta Sahib can be found on the FDAzilla website, https://fdazilla.com/.

the unregistered walk-in refrigerator, set to 4 degrees Celsius: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories Ltd., Paonta Sahib, Simour District, India, February 20–25, 2006.

“because we did not understand FDA to have requested it.”: “Re: Ranbaxy’s Responses to Food and Drug Administration (FDA) Warning Letter of June 15, 2006.” Alok Ghosh, Vice President, Global Quality, to Mr. Nicholas Buhay, Acting Director, Division of Manufacturing and Product Quality, August 29, 2006.

“it remains unclear to us”: Nicholas Buhay, Acting Director, Division of Manufacturing and Product Quality, CDER, FDA, U.S. Department of Health and Human Services, “Warning Letter” to Ramesh Parekh, Vice President, Manufacturing, Ranbaxy Laboratories Ltd., June 1, 2006, 4.

Brown and Horan set out to inspect Dewas: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories Ltd., Dewas, India, February 27–March 2, 2006.

“after the fact or outside of the laboratory operation”: Ibid., 21.

CHAPTER 13: OUT OF THE SHADOWS

“Since this is a more formal meeting”: “Malvinder Singh,” “Re: Information Meeting,” email to Debbie Robertson, September 19, 2006.

On November 29, 2006, Singh led a delegation: This scene was re-created, in part, through reference to the minutes of the Ranbaxy-FDA meeting, November 29, 2006.

the assignment sheet for the inspection: U.S. Department of Health and Human Services, FDA, Karen Takahashi, Consumer Safety Officer, HFD-325, “Request for ‘For Cause’ Assignment FACTS #792363, Firm: Ranbaxy Laboratories, Ltd., Paonta Sahib, Himachal Pradesh, India FEI: 3002807978,” to Rebecca Hackett, Branch Chief, HFC-130, January 16, 2007.

Hernandez arrived on January 26, 2007: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories Ltd., Paonta Sahib, India, January 26–February 1, 2007.

CHAPTER 14: “DO NOT GIVE TO FDA”

New Jersey to New Delhi, Ranbaxy issued a statement: Patricia Van Arnum, “Ranbaxy Comments on Merck KGaA Generics Rumors, Confirms Federal Raid in NJ,” PharmTech, February 15, 2007, http://www.pharmtech.com/ranbaxy-comments-merck-kgaa-generics-rumors-confirms-federal-raid-nj (accessed September 21, 2018).

It was the company’s own secret: Ranbaxy, “Sotret—Investigation Report” (four-page internal document).

the internal auditor at WorldCom: Cynthia Cooper, Extraordinary Circumstances: The Journey of a Corporate Whistleblower (Hoboken, NJ: Wiley, 2009), 281.

had represented Monica Lewinsky: Saundra Torry, “Lewinsky Legal Team Brings Credibility,” Washington Post, June 4, 1998.

dated back to the Civil War: Henry Scammell, Giantkillers: The Team and the Law That Help Whistle-Blowers Recover America’s Stolen Billions (New York: Atlantic Monthly Press, 2004), 36.

the infamous $640 toilet seat: Eric Wuestewald, “Timeline: The Long, Expensive History of Defense Rip-offs,” Mother Jones, December 18, 2013, https://www.motherjones.com/politics/2013/12/defense-military-waste-cost-timeline/ (accessed September 21, 2018).

CHAPTER 15: “HOW BIG IS THE PROBLEM?”

and they piled up in back offices: The FDA’s media relations office, in response to a written question about whether the agency routinely reviews annual reports, stated: “Reports are reviewed as appropriate.”

that required inspection by the FDA skyrocketed: Pew Charitable Trust, “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” July 12, 2011.

The FDA did not approve: Seven months after Ranbaxy failed to address all the issues raised by investigators in the February 12, 2008, Form 483, the FDA issued a warning letter that stated, “Until all corrections have been completed and FDA can confirm your firm’s compliance with CGMPs, this office will recommend disapproval of any new applications or supplements listing your firm as a manufacturing location of finished dosage forms and active pharmaceutical ingredients.” Richard L. Friedman, Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, Silver Spring, MD, to Mr. Malvinder Singh, “Warning Letter 320-08-03,” September 16, 2008.

On December 12, 2007, USAID: Jean C. Horton, Acting Director, Office of Acquisition and Assistance, USAID, “Re: Show Cause,” letter to Venkat Krishnan, Vice President and Regional Director, Ranbaxy Laboratories Inc., December 12, 2007.

By standing at the edge of the property: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories Ltd., Paonta Sahib, Himachal Pradesh State, India, March 3–7, 2008.

He became “agitated and desperate”: Ibid., 44.

withdrew its tacrolimus application: Dr. T. G. Chandrashekhar, “Re: Ranbaxy’s Responses to Food and Drug Administration (FDA) Form 483 Observations of Batamandi during Inspection Conducted March 3–7, 2008,” letter to John M. Dietrick, May 1, 2008.

CHAPTER 16: DIAMOND AND RUBY

“I am an entrepreneur at heart”: Archna Shukla, “Like Father Like Son,” Business Today, August 13, 2006.

Ranbaxy’s bottom line was “sagging”: “Corporate Profile—Finding a Cure for Ranbaxy’s Ills,” AsiaMoney, March 1, 2006.

The surgeon arrived at work to: Vidya Krishnan, “Private Practice: How Naresh Trehan Became One of India’s Most Influential Doctor-Businessmen,” The Caravan—A Journal of Politics and Culture, February 1, 2015.

with manufacturing plants in eleven countries: Daiichi Sankyo, “Ranbaxy to Bring in Daiichi Sankyo as Majority Partner; Strategic Combination Creates Innovator and Generic Pharma Powerhouse,” news release, June 11, 2008, https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005635.html (accessed June 15, 2018).

“India will be the trump card”: Eiichiro Shimoda, “Daiichi Sankyo Targets Generics,” Nikkei Weekly, June 16, 2008.

in the public domain: In a written statement, Malvinder Singh categorically denied that he had deceived Daiichi Sankyo: “There was no misrepresentation or concealment of information from Daiichi Sankyo (Daiichi) since the fact of the US FDA & DOJ investigation was all in the public domain and was also specifically informed to Daiichi.” He blamed the Japanese company, instead, for poor management of Ranbaxy. “All allegations of fraud/concealment raised by Daiichi after more than 3 years after acquiring control over Ranbaxy, pursuant to a due-diligence which lasted around 10 months, are false and a mere afterthought aimed at vindicating the losses that Ranbaxy (controlled by Daiichi) suffered due to the recall of Atorvastatin (Gx version of Lipitor) necessitated by the presence of glass particles in the drug, manufactured under Daiichi’s watch which made the drugs unsafe for consumption (Interestingly the Atorvastatin recall happened in November 2012 the period when Daiichi also filed the arbitration proceedings).”

called the sale an “emotional decision”: Eban, “Dirty Medicine.”

on July 3, 2008, the Maryland U.S. Attorney: United States of America v. Ranbaxy Inc., and Parexel Consulting, Motion to Enforce Subpoenas and Points and Authorities (U.S. District Court for the District of Maryland, Southern Division, July 3, 2008).

the twenty-seven others: According to the FDA’s Orange Book, a compendium of FDA-approved drug products, the agency approved twenty-seven unique Abbreviated New Drug Applications (ANDAs) submitted by Ranbaxy from August 2005 to August 2008, which included different dosage forms of eleven different drugs.

CHAPTER 17: “YOU JUST DON’T GET IT”

“pattern of systemic fraudulent conduct”: United States of America v. Ranbaxy Inc., and Parexel Consulting, Motion to Enforce Subpoenas and Points and Authorities (U.S. District Court for the District of Maryland, Southern Division, July 3, 2008).

In a cagey call with reporters: Eban, “Dirty Medicine.”

said Dr. Janet Woodcock, CDER’s director: “FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India,” FDA News, news release, September 16, 2008.

Deb Autor told reporters: FTS-HHS FDA, “Transcript of Media Briefing on Ranbaxy Labs,” news release, September 17, 2008.

what leverage did the FDA have?: In a written statement, Deb Autor responded to the characterization of her remarks provoking anger inside the agency: “No one at the Agency told me that they considered my remarks misleading or detrimental to the case FDA was trying to build against Ranbaxy. If they had done so, that would certainly have been thoroughly considered and addressed.”

The FDA announced that it would level the harshest punishment: Saundra Young, “FDA Says India Plant Falsified Generic Drug Data,” CNN, February 25, 2009, http://edition.cnn.com/2009/HEALTH/02/25/fda.india.generic.drugs/index.html (accessed June 11, 2018).

should not mention the SAR: In a written statement provided by a spokesperson, Lavesh Samtani said, “Although I cannot discuss anything covered by attorney-client privilege, I can tell you that all material I shared with Daiichi was done in a manner that protected such privilege. After resolving the FDA and DOJ issues on behalf of a Daiichi-controlled Ranbaxy, I chose to leave to start a new venture in 2014 and remain on good terms with Dr. Une.”

CHAPTER 18: CONGRESS WAKES UP

round-the-world airline trip and receipts: “Guilty Plea in Drug Case,” New York Times, May 26, 1989, https://www.nytimes.com/1989/05/26/business/guilty-plea-in-drug-case.html (accessed May 21, 2018).

hired by Mylan, the respected generic drug company: Milt Freudenheim, “Exposing the FDA,” New York Times, September 10, 1989.

a full-scale investigation and send the trash: Edmund L. Andrews, “A Scandal Raises Serious Questions at the FDA,” New York Times, August 13, 1989.

Dingell’s committee uncovered corruption: Malcolm Gladwell and Paul Valentine, “FDA Battles for Authority amid Generic-Drug Scandal,” Washington Post, August 16, 1989, https://www.washingtonpost.com/archive/politics/1989/08/16/fda-battles-for-authority-amid-generic-drug-scandal/54ef2d8b-4a9d-45b0-851a-4446d139137e/?noredirect=on&utm_term=.33b423bb01c7 (accessed July 31, 2018).

“a swamp that must be drained”: William C. Cray and C. Joseph Stetler, Patients in Peril? The Stunning Generic Drug Scandal (n.p., 1991), 113.

Congressional hearings in 1989: See Cray and Stetler, Patients in Peril?

“horrible world of overwhelming work”: Seaman and Landry, Mylan, 62.

whose CEO had given Chang $23,000: “Founder of Generic Drug Firm Fined, Gets Jail Term in Bribery,” Los Angeles Times, September 15, 1989, http://articles.latimes.com/1989-09-15/news/mn-183_1_generic-drug (accessed May 21, 2018).

fraud or corruption charges: The prosecutorial dragnet finally caught Marvin Seife, the FDA’s director of the Office of Generic Drugs. Though well-meaning and candid with investigators, he also had what the Washington Post dubbed a “lunch problem.” He enjoyed regular lunches with industry executives, who lobbied him during the meals and then picked up the tab. He’d been reprimanded for the habit almost a decade earlier. At the scandal’s height, he signed an affidavit claiming that the lunches had stopped, when they hadn’t. In 1990, Seife was convicted on two counts of perjury and sentenced to ten months in a Texas prison. There, he was given ill-fitting shoes. Seife was a diabetic and prone to foot infections. By the time prison authorities got him to a hospital, one of his legs had to be amputated below the knee. Phil McCombs, “The Bungled Punishment of Prisoner Seife,” Washington Post, April 3, 1992.

confidence in the generic drug industry: Joe Graedon and Teresa Graedon, “Generic Drugs Still a Good Buy,” Buffalo News, September 13, 1989, http://buffalonews.com/1989/09/13/generic-drugs-still-a-good-buy/ (accessed May 21, 2018).

90 million kilograms by 2008: Pew Health Group, Pew Charitable Trusts, “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” white paper, March 201125.

“a string of ticking time bombs”: Scenes depicting the tense relationship between the FDA and Congress were re-created based on transcripts of congressional hearings, including: Janet Woodcock and Deborah Autor, “The Heparin Disaster: Chinese Counterfeits and American Failures,” testimony before a hearing of U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, April 29, 2008; William Hubbard, “FDA’S Foreign Drug Inspection Program: Weaknesses Place Americans at Risk,” testimony before hearing of U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, April 22, 2008.

cheap active ingredients imported from China: Cheryl A. Thompson, “FDA Admits to Lacking Control over Counterfeit Drug Imports,” Health-System Pharmacists News (American Society of Health-System Pharmacists), June 9, 2000.

a team worked around the clock: Beth Miller, “Drama in the Dialysis Unit,” Outlook (Office of Medical Public Affairs, Washington University in St. Louis) (Spring 2009), https://core.ac.uk/download/pdf/70380372.pdf (accessed May 28, 2018).

with a similar-sounding name: Marc Kaufman, “FDA Says It Approved the Wrong Drug Plant,” Washington Post, February 19, 2008.

finally traveled to Changzhou: Richard L. Friedman, Public Health Service, FDA, “Warning Letter” to Dr. Van Wang, WL: 320-08-01, April 21, 2008.

The ingredient mimicked heparin: Amanda Gardner, “Researchers Identify Contaminant in Tainted Heparin,” Washington Post, April 23, 2008.

“continuing to aggressively investigate the situation”: FDA, “Postmarket Drug Safety Information for Patients and Providers—Information on Heparin,” last updated November 1, 2018, https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm.

“left or right and you’ll see it”: Suketu Mehta, Maximum City: Bombay Lost and Found (New York: Random House, 2004), 192.

CHAPTER 19: SOLVING FOR X

The story described how the United States was importing: Richard Knox, “As Imports Increase, a Tense Dependence on China,” NPR, Morning Edition, May 25, 2007.

best defense for his patients was medication: Bernard J. Gersh et al., “2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy,” Circulation 124 (December 8, 2011): e783–831, http://circ.ahajournals.org/content/124/24/e783 (accessed May 29, 2018).

“not related to product efficacy”: In 2013, the year after Karen Wilmering stopped taking Glenmark’s pravastatin, Glenmark recalled multiple lots of three different drugs, including 246,528 bottles of pravastatin, after consumers complained that the medicines gave off a strong fishy odor. A Glenmark spokesperson noted that the company could not comment on Wilmering’s specific complaint because her case was never reported directly to the company: “Patient safety is our first priority and we take all claims on adverse events or product quality complaints very seriously.” See “Glenmark Recalls Three Drugs from U.S. Market,” Economic Times, May 23, 2013.

a trail of aggrieved patients: Patient complaints made in 2013 about various Zydus drugs appear on the websites MedsChat.com and ConsumerAffairs.com.

started marketing the first generic version: Sarah Turner, “AstraZeneca to Launch Generic of Its Own Heart Drug,” MarketWatch, November 22, 2006, https://www.marketwatch.com/story/astrazeneca-to-launch-generic-version-of-its-own-heart-drug (accessed May 29, 2018).

Sandoz quietly recalled its drug: Tom Lamb, “Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly,” Drug Injury Watch, December 5, 2008, http://www.drug-injury.com/druginjurycom/2008/12/generic-drug-recall-metoprolol-er-tablets-by-sandoz--recall-metoprolol-er-tablets-by-sandozwwwipcrxcompharmacy-industry-n.html (accessed May 29, 2018).

“Does not comply with the dissolution test of the USP monograph”: The Cleveland Clinic pharmacist wasn’t the only person to question why Ethex would be permitted to sell a drug that did not comply with the USP monograph. The independent drug testing organization Consumer Lab also investigated the drug and package insert and published a report; see “Drug Investigation: Toprol XL vs. Generic Metoprolol Succinate Extended-Release (ER) Tablets,” product review, Consumer Lab.com, December 31, 2008, http://coyo.ga/www.consumerlab.com/reviews/Toprol_vs_Generic_Metoprolol/Toprol/ (accessed May 29, 2018).

Ethex announced a sweeping recall of more than sixty products: Tom Lamb, “January 2009: ETHEX Corp. Issues Voluntary Recall of All Pills Due to Suspected Manufacturing Problems,” Drug Injury Watch, February 2, 2009, http://www.drug-injury.com/druginjurycom/2009/02/ethex-corporation-issues-nationwide-voluntary-recall-of-products-press-release-includes-list-of-all-generic-drugs-by-ethex.html (accessed May 29, 2018).

over $27 million: Federal Bureau of Investigation, “Ethex Corporation, a Subsidiary of KV Pharmaceutical, Pleads Guilty to Two Felonies and Agrees to Pay United States $27,568,921 for Fine, Restitution, and Forfeiture,” news release, March 2, 2010, https://archives.fbi.gov/archives/stlouis/press-releases/2010/sl030210.htm (accessed December 10, 2018).

And Brown never did: In a written statement, Dr. Reddy’s asserted that its tacrolimus is safe and effective, and made under identical FDA standards as brand-name drugs. Since the drug’s launch in 2010, the company says that it has manufactured more than 569 million capsules for the U.S. market and has received only twenty lack-of-effect complaints, the majority of them within the first two years of the drug’s launch. “It is common behavior to get lack-of-effectiveness complaints at the beginning of a launch cycle as the patient population adjusts to the idea of generics replacing the innovator drugs,” the company stated.

“the Dr. Reddy’s brand of Prograf”: According to the FDA’s MedWatch database, the report from Loma Linda was filed on October 28, 2013, under the defect “Potency Questioned.”

which they published in 2017: Rita R. Alloway, Alexander A. Vinks, Tsuyoshi Fukuda, Tomoyuki Mizuno, Eileen C. King, Yuanshu Zou, Wenlei Jiang, E. Steve Woodle, Simon Tremblay, Jelena Klawitter, Jost Klawitter, and Uwe Christians, “Bioequivalence between Innovator and Generic Tacrolimus in Liver and Kidney Transplant Recipients: A Randomized, Crossover Clinical Trial,” PLOS Medicine, November 14, 2017, doi:10.1371/journal.pmed.1002428.

CHAPTER 20: A TEST OF ENDURANCE

a claim that a Justice Department official would later deny: In a written statement, in response to a number of questions, a Justice Department official stated, without being more specific, “The Department of Justice disagrees with these previously unvoiced allegations against its personnel. These allegations are false and could not have in any way affected the outcome of the investigation.”

CHAPTER 21: A DEEP, DARK WELL

For three decades, Joe and Terry Graedon: The Graedons’ views on generic drugs over the years, as well as consumer comments and complaints about specific drugs, can be found on their website, http://www.peoplespharmacy.com/.

published these cases in a 1998 newspaper column: Joe Graedon and Terry Graedon, “Are Generic Equivalents as Good as Brand Name Drugs?” part 2 of 3, King Features Syndicate, May 18, 1998.

By 2002, Joe Graedon had contacted the FDA: Joe Graedon and Teresa Graedon, “The Generic Drug Quandary: Questions about Quality,” in Best Choices from the People’s Pharmacy: What You Need to Know before Your Next Visit to the Doctor or Drugstore (New York: Rodale, 2006), 22.

fall below 80 percent or rise above 125 percent: Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (Washington, DC: FDA, CDER, 1992).

patients taking it began writing in to the Graedons: After both Toprol XL and Wellbutrin XL went generic, the Graedons saw an uptick in patient complaints, many of which can be found on their website (http://www.peoplespharmacy.com/).

more than eighty-five reports: Anna Edney, “Teva Pulls Version of Wellbutrin XL on Effectiveness,” Bloomberg, October 4, 2012.

ConsumerLab tested the 300-milligram dose: “Generic Bupropion Is Not Always the Same as Brand-Name Wellbutrin,” ConsumerLab.com, October 12, 2007, updated October 17, 2013, https://www.consumerlab.com/reviews/Wellbutrin_vs_Generic_Bupropion/Wellbutrin/ (accessed May 29, 2018).

Graedon and Temple of the FDA were both asked to be guest: Larry Mantle, producer, “Generic Drug Safety,” KPCC, AirTalk, December 19, 2007.

assured consumers that it had been right: FDA, Division of Drug Information (DDI), “Drug Information Update—Review of Therapeutic Equivalence Generic Bupropion XL 300 Mg and Wellbutrin XL 300 Mg,” news release, April 16, 2008.

the FDA simply reviewed the bioequivalence data: Although Teva marketed and sold generic Budeprion, the drug was manufactured and developed by Impax, which provided bioequivalence data in its 2003 application to the FDA. After the drug was pulled, Teva sued Impax for misrepresenting its bioequivalence. These events were reported in Roger Bate et al., “Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA,” Trends in Pharmacological Science 37, no. 3 (December 2015), doi:10.1016/j.tips.2015.11.005; and Dan Packel, “Impax Must Pay for GSK Wellbutrin Settlement, Teva Says,” Law360, August 31, 2017, https://www.law360.com/articles/959538/impax-must-pay-for-gsk-wellbutrin-settlement-teva-says (accessed May 29, 2018).

Teva and Impax planned to conduct a bioequivalence study: Andy Georgiades, “Teva Aims to Quell Concerns with Generic Wellbutrin Trial,” Wall Street Journal (Toronto), December 2, 2009.

not therapeutically equivalent: After the FDA released its findings in 2012, Teva released a statement: “Upon receiving the communication from the U.S. Food and Drug Administration, Teva has immediately ceased shipment of Impax’s 300 mg Budeprion XL. This update to the FDA’s guidance affects the bioequivalence rating of the product and does not reflect any safety issue. Teva’s first priority is to our patients and providing them with quality medicines.” Teva did not respond to repeated requests for comment for this book.

vice president of global regulatory intelligence and policy—at Teva: Pat Wechsler, Bloomsberg News, “Teva Hires Gary Buehler Away from FDA,” SFGate, February 9, 2012, https://www.sfgate.com/business/article/Teva-hires-Gary-Buehler-away-from-FDA-3170563.php (accessed June 10, 2018).

Horrified, she watched as the bug: Carla Stouffer’s complaint, though filed with the FDA, never reached Dr. Reddy’s. The company stated: “From 2011 to date, Dr. Reddy’s has not received any communication, complaint or intimation relating to insect in dosage forms of this product.” Descriptions of adverse events were pulled from the FDA’s Drug Quality Reporting System (DQRS) (MedWatch Reports) database. Carla Stouffer’s complaint is logged as number 1603903 in the DQRS database. Each year the FDA receives millions of such reports from patients, caregivers, and the general public; see Lichy Han, Robert Ball, Carol A. Pamer, Russ B. Altman, and Scott Proestel, “Development of an Automated Assessment Tool for MedWatch Reports in the FDA Adverse Event Reporting System,” Journal of the American Medical Informatics Association 24, no. 5 (September 1, 2017): 913–20, doi:10.1093/jamia/ocx022.

CHAPTER 22: THE $600 MILLION JACKET

group of U.S. senators reminded the FDA commissioner in a March 2011 letter: “U.S. Sen. Harkin and Others Urge FDA to Avoid Delays of Generic Drug Approvals,” Pharma Letter, March 16, 2011, https://www.thepharmaletter.com/article/us-sen-harkin-and-others-urge-fda-to-avoid-delays-of-generic-drug-approvals (accessed December 11, 2018).

owing to a settlement with Pfizer: “Ranbaxy, Pfizer Sign Truce over Lipitor,” Economic Times, June 19, 2008, https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/ranbaxy-pfizer-sign-truce-over-lipitor/articleshow/3143801.cms (accessed December 11, 2018).

“where this is going to come out”: Eban, “The War over Lipitor.”

company operated on razor-thin margins: Ashish Gupta, “The Pills That Saved Ranbaxy,” Fortune India, August 5, 2012, https://www.fortuneindia.com/ideas/the-pills-that-saved-ranbaxy/100819 (accessed May 28, 2018).

Since 2002, individual reviewers had flagged anomalies: Depictions of anomalies in Ranbaxy’s atorvastatin application, as well as back-and-forth correspondence between the FDA and Ranbaxy, were drawn from FDA, Center for Drug Evaluation and Research, Approval Package for Application Number: ANDA 076477Orig1s000, Sponsor: Ranbaxy, Inc., November 30, 2011, https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076477Orig1s000.pdf (accessed May 24, 2018).

An inspection of Ranbaxy’s research and development laboratory in Gurgaon: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories, Gurgaon, India, April 27–May 12, 2009.

In February 2009, it had leveled a rare Application Integrity Policy: FDA, Center for Drug Evaluation and Research, “Enforcement Activities by FDA—Regulatory Action against Ranbaxy,” updated May 15, 2017, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm118411.htm (accessed May 28, 2018).

a hard-hitting motion to dismiss Mylan’s suit: “District Court Dismisses Mylan’s Complaint against FDA Concerning Generic Lipitor,” Orange Book Blog, May 2, 2011, http://www.orangebookblog.com/2011/05/district-court-dismisses-mylans-complaint-against-fda-concerning-generic-lipitor.html (accessed May 28, 2018); Mylan Pharms. v. FDA and Ranbaxy Labs, 789 F.Supp.2d 1, Civil Action No. 11-566 (JEB) (U.S. District Court for the District of Columbia, 2011).

Wall Street analysts had mapped out complex flow charts: Eban, “The War over Lipitor.”

with a fateful recommendation: Director, Office of Compliance, “Proposal to Review Ranbaxy’s Atorvastatin ANDA,” memo to Director, Center for Drug Evaluation and Research, Food and Drug Administration, May 11, 2011.

once every two years: At the time, the FDA endeavored to inspect each plant every two years. That changed in 2012 with the passage of a law called The FDA Safety and Innovation Act (FDASIA), which codified into law a risk-based model for assessing when to inspect plants. Jerry Chapman, “How FDA And MHRA Decide Which Drug Facilities To Inspect—And How Often,” Pharmaceutical Online, July 13, 2018, https://www.pharmaceuticalonline.com/doc/how-fda-and-mhra-decide-which-drug-facilities-to-inspect-and-how-often-0001 (accessed February 7, 2019).

FDA investigators arrived at Toansa: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories, Toansa, India, November 21–25, 2011.

At 8:12 p.m., the agency issued a press release: “FDA Confirms Nod for Ranbaxy’s Generic Lipitor,” Reuters, December 01, 2011, https://www.reuters.com/article/us-ranbaxy/fda-confirms-nod-for-ranbaxys-generic-lipitor-idUSTRE7B007L20111201 (accessed June 11, 2018).

Arun Sawhney, addressed his staff: Vikas Dandekar, “Ranbaxy Launches AG Version of Caduet as CEO Likens Lipitor Deal with Teva to an Insurance Policy,” The Pink Sheet, December 6, 2011.

nearly $600 million within six months: Ashish Gupta, “The Pills That Saved Ranbaxy,” Fortune India, August 5, 2012.

would prove dismayingly well founded: “Ranbaxy Halts Generic Lipitor Production after Recall: FDA,” Reuters, November 29, 2012, https://www.reuters.com/article/us-ranbaxy-lipitor-idUSBRE8AS1C620121129 (accessed May 24, 2018).

CHAPTER 23: THE LIGHT SWITCH

The officials took them to the MP-11 plant: FDA, Form 483, Inspectional Observations, Ranbaxy, Toansa, India, December 7–14, 2012.

those who’d signed the logs had not actually: Ibid., 2–3.

to the United States soared: According to the website FDAzilla, FDA investigator Muralidhara Gavini performed ninety facility inspections in India between 2001 and 2011. An analysis of these records showed that in at least forty-one of these inspections, the FDA had never visited the facility before and had to assess whether to approve the plant to export into the U.S. market. Gavini approved thirty-five of those forty-one facilities, a roughly 85 percent approval rate.

On his fifth inspection in India, at RPG Life Sciences: FDA, “Establishment Inspection Report,” RPG Life Sciences Ltd., Ankleshwar, India, November 20–24, 2012.

a manufacturing plant in Kalyani . . . owned by Fresenius Kabi: FDA, “Form 483: Inspectional Observations,” Fresenius Kabi Oncology Ltd., Nadia, India, January 14–18, 2013.

he saw what looked like earlier tests: Ibid., 1.

On March 18, 2013, Peter Baker arrived at the main plant of Wockhardt Ltd.: FDA, “Form 483: Inspectional Observations,” Wockhardt Ltd., Aurangabad, India, March 18–22, 2013.

“emergency plan in place prior to arrival”: FDA, Establishment Inspection Report, Wockhardt Ltd., Waluj, Aurangabad, March 18–22, 2013, 7. The threats the FDA team received at that inspection were documented in Pallavi Ail, “USFDA Says Team Threatened during Wockhardt Inspection,” Financial Express (Mumbai), May 28, 2014.

CHAPTER 24: WE ARE THE CHAMPIONS

$500 million to settle the case: Ranbaxy Laboratories, “Ranbaxy Laboratories Sets Aside $500 Million to Settle U.S. Probe, Signs Consent Decree with FDA,” news release, December 21, 2011.

Beato responded angrily to a government lawyer: Conversation with Andrew Beato, January 3, 2013, notes taken by Dinesh Thakur.

Motz approved the settlement: United States of America v. Ranbaxy USA, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ranbaxy, Inc., Ohm Laboratories, Inc., Ranbaxy Laboratories Ltd., filed by Dinesh S. Thakur, Settlement Agreement (U.S. District Court for the District of Maryland, Southern Division, May 10, 2013), PACER Case Locator Case 1:07-cv-00962-JFM.

appeared on Fortune magazine’s U.S. website: Eban, “Dirty Medicine.”

Daiichi Sankyo issued a press release: Daiichi Sankyo, Media Relations, “Ranbaxy Announces Improved Business Standards and Quality Assurance Initiatives,” news release, May 22, 2013. https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005976.html (accessed December 16, 2018).

CHAPTER 25: CRASHING FILES

with nine manufacturing plants worldwide: Katie Thomas, “Mylan Buys Drug Maker of Generic Injectables,” New York Times, February 27, 2013.

largely credited to Bresch: Gardiner Harris, “Deal in Place for Inspecting Foreign Drugs,” New York Times, August 13, 2011.

a sterile injectable plant in Bangalore, Karnataka: FDA, “Form 483: Inspectional Observations,” Mylan Laboratories Ltd., Bangalore, India, June 17–27, 2013.

a dangerously sloppy plant: Ibid.

“disruptions of the unidirectional air flow”: Ibid., 3.

the investigators found “crushed insects”: Michael Smedley, Acting Director, Office of Manufacturing and Product Quality, CDER, Office of Compliance, FDA, “Warning Letter” to Venkat Iyer, CEO, Agila Specialties Private Ltd., September 9, 2013, 2.

he and his team exceeded targets: Between 2011 and 2017, proxies that Mylan filed with the U.S. Securities and Exchange Commission show that the company exceeded its own targets for the number of applications submitted to global regulators. One such example includes a target of 140 global submissions in 2012, while the actual number of applications submitted was 171. U.S. Securities and Exchange Commission, proxy statement, Mylan Inc., April 12, 2013, 26. As another example, in 2017, the target for applications was 135, while the actual number submitted was 184. U.S. Securities and Exchange Commission, proxy statement, Mylan N.V., May 30, 2018, 46. The targeted number of global regulatory submissions comprised one-quarter of Rajiv Malik’s annual incentive compensation, which was one-third of his overall compensation, according to the proxies.

It hiked the price: Alex Nixon, “Firestorm Grows over Price Hikes on EpiPen,” Pittsburgh Tribune Review, August 25, 2016.

10 percent of the company’s revenue: Figures for Bresch’s 2007 compensation are drawn from U.S. Securities and Exchange Commission, proxy statement, Mylan Inc., April 5, 2010, 26. Her 2015 compensation comes from U.S. Securities and Exchange Commission, proxy statement, Mylan N.V., May 30, 2018, 53. The 2014 compensation for Bresch and Malik comes from U.S. Securities and Exchange Commission, proxy statement, Mylan N.V., May 23, 2017, 62. The figure for EpiPen as providing 10 percent of the company’s revenue comes from U.S. Congress, Full House Committee on Oversight and Government Reform, “Reviewing the Rising Price of EpiPens: Testimony of Heather Bresch, CEO of Mylan,” 114th Cong., 2nd sess., September 21, 2016, https://oversight.house.gov/hearing/reviewing-rising-price-epipens-2/, 54.

Overnight, Bresch became: Andrew Buncombe, “Mylan CEO’s Salary Soared by 671% as Firm Hiked EpiPen Prices,” Independent, August 26, 2016.

In a disastrous CNBC interview: Dan Mangan, “Mylan CEO Bresch: ‘No One’s More Frustrated than Me’ about EpiPen Price Furor,” CNBC, Squawk Box, August 25, 2016.

none of this made any sense: On August 17, 2017, Mylan Inc. and Mylan Specialty LLP agreed to settle a False Claims Act lawsuit and pay $465 million to the U.S. Justice Department for knowingly misclassifying EpiPen as a generic drug, rather than as a brand drug, to avoid paying greater Medicaid rebates. U.S. Department of Justice, Office of Public Affairs, “Mylan Agrees to Pay $465 Million to Resolve False Claims Act Liability for Underpaying EpiPen Rebates,” news release, August 17, 2017.

the Pittsburgh Post-Gazette uncovered: Patricia Sabatini and Len Boselovic, “MBA Mystery in Morgantown: Questions Raised over How WVU Granted Mylan Executive Her Degree,” Pittsburgh Post-Gazette, December 21, 2007.

allegations that Executive Chairman Robert Coury: Tracy Staton, “Think EpiPen Is Mylan’s First Scandal? Here’s a Timeline of Jet Use, an Unearned MBA, and More,” FiercePharma, September 2, 2016, https://www.fiercepharma.com/pharma/think-epipen-mylan-s-first-scandal-here-s-a-timeline-jet-use-resume-fakery-and-more (accessed June 13, 2018).

Bresch found herself grilled under oath: U.S. Congress, Full House Committee on Oversight and Government Reform, “Reviewing the Rising Price of EpiPens: Testimony of Heather Bresch, CEO of Mylan,” 114th Cong., 2nd sess., September 21, 2016, https://oversight.house.gov/hearing/reviewing-rising-price-epipens-2/ (accessed June 19, 2018).

Over the course of nine days: FDA, “Form 483: Inspectional Observations,” Mylan Laboratories Ltd., Sinnar, Nashik District, Maharastra, India, September 5–14, 2016.

“instrument malfunction,” “power loss”: Ibid., 7.

Within two months, three investigators: FDA, “Form 483: Inspectional Observations,” Mylan Pharmaceuticals Inc., Morgantown, West Virginia, November 7–18, 2016.

“the accuracy and integrity of data”: FDA, “Warning Letter 320-17-32” (re: Mylan Laboratories Ltd., Nashik, FDF), letter to Rajiv Malik, President, Mylan Pharmaceuticals Inc., April 3, 2017.

CHAPTER 26: THE ULTIMATE TESTING LABORATORY

a very sick thirteen-year-old boy: Jason W. Nickerson, Amir Attaran, Brian D. Westerberg, Sharon Curtis, Sean Overton, and Paul Mayer, “Fatal Bacterial Meningitis Possibly Associated with Substandard Ceftriaxone—Uganda, 2013,” Morbidity and Mortality Weekly Report 64, nos. 50–51 (January 1, 2016), 1375–77, doi:10.15585/mmwr.mm6450a2.

The throng of patients usually exceeded: Chris Obore, “Time Bomb: The Inside Story of Mulago Hospital’s Troubles,” Daily Monitor, January 20, 2013, http://www.monitor.co.ug/News/National/Time-bomb-The-inside-story-of-Mulago-hospital-s-troubles/688334-1669688-akvcb7/index.html (accessed June 3, 2018).

in the manufacture of drugs bound for the least-regulated markets: Depictions of variations in drug quality found around the world were drawn from several scientific studies, including Roger Bate, Ginger Zhe Jin, Aparna Mathur, and Amir Attaran, “Poor Quality Drugs and Global Trade: A Pilot Study,” Working Paper 20469 (Cambridge, MA: National Bureau for Economic Research, September 2014), doi:10.3386/w20469; and Richard Preston Mason, Robert F. Jacob, and Seth A. Gerard, “Atorvastatin Generics Obtained from Multiple Sources Worldwide Contain a Methylated Impurity That Reduces Their HMG-CoA Reductase Inhibitory Effects,” Journal of Clinical Lipidology 7, no. 3 (2013): 287, doi:10.1016/j.jacl.2013.03.096.

He and Westerberg published a case report: Nickerson et al., “Fatal Bacterial Meningitis Possibly Associated with Substandard Ceftriaxone—Uganda, 2013.”

every single sample failed quality evaluations: Anita Nair, Stefanie Strauch, Jackson Lauwo, Richard W. O. Jähnke, and Jennifer Dressman, “Are Counterfeit or Substandard Anti-infective Products the Cause of Treatment Failure in Papua New Guinea?” Journal of Pharmaceutical Sciences 100, no. 11 (June 30, 2011): 5059–68, doi:10.1002/jps.22691.

Peter Baker inspected the company’s plant northeast of Beijing: FDA, “Form 483: Inspectional Observations,” CSPC Zhongnuo Pharm (shijiazhuang) Co. Ltd., China, March 23–27, 2015.

less than 70 percent of the required active ingredient: Elizabeth Pisani, “Losing the War on Bugs,” Prospect (February 2016).

They zeroed in on oxytocin and ergometrine: Eric Karikari-Boateng and Kwasi Poku Boateng, Post-Market Quality Surveillance Project: Maternal Healthcare Products (Oxytocin and Ergometrine) on the Ghanaian Market, Ghana Food and Drugs Authority, Promoting the Quality of Medicines Program, USAID, February 2013.

Shanghai Desano, whose factory in Binhai had been inspected: World Health Organization, “Inspection Report,” Shanghai Desano Chemical Pharmaceutical Co., China, March 18, 2011.

Caudron and his colleagues published a landmark paper: J.-M. Caudron, N. Ford, M. Henkens, C. Macé, R. Kiddle-Monroe, and J. Pinel, “Substandard Medicines in Resource-Poor Settings: A Problem That Can No Longer Be Ignored,” European Journal of Tropical Medicine and International Health 13, no. 8 (August 13, 2008): 1062–72, doi:10.1111/j.1365-3156.2008.02106.x.

the British government commissioned: Jim O’Neill, “Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations,” Review on Antimicrobial Resistance (December 2014), https://amr-review.org/sites/default/files/AMR%20Review%20Paper%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf (accessed June 3, 2018).

fingered substandard drugs as a culprit: Ian Williams, “The Race to Contain Drug-Resistant Malaria,” NBCNews.com, January 22, 2011, http://worldblog.nbcnews.com/_news/2011/01/22/5825008-the-race-to-contain-drug-resistant-malaria (accessed June 3, 2018).

he coauthored an editorial: Paul N. Newton, Céline Caillet, and Philippe J. Guerin, “A Link between Poor Quality Antimalarials and Malaria Drug Resistance?” Expert Review of Anti-infective Therapy 14, no. 6 (May 23, 2016): 531–33, doi:10.1080/14787210.2016.1187560.

the first study to link: Muhammad Zaman and Zohar B. Weinstein, “Evolution of Rifampicin Resistance Due to Substandard Drugs in E. Coli and M. Smegmatis,” forthcoming in Antimicrobial Agents and Chemotherapy, posted online November 5, 2018.

wrote in a 2015 report: Elizabeth Pisani, “Antimicrobial Resistance and Medicine Quality,” AMR Review (November 2015), https://amr-review.org/sites/default/files/ElizabethPisaniMedicinesQualitypaper.pdf (accessed November 30, 2018).

a Nevada woman in her seventies returned home: Lei Chen, “Notes from the Field: Pan-Resistant New Delhi Metallo-Beta-Lactamase-Producing Klebsiella Pneumoniae—Washoe County, Nevada, 2016,” Morbidity and Mortality Weekly Report 66, no. 1 (January 13, 2017): 33, https://www.cdc.gov/mmwr/volumes/66/wr/mm6601a7.htm?s_cid=mm6601a7_w (accessed June 3, 2018).

a “nightmare bacteria” with no known cure: Sabrina Tavernise, “Infection Raises Specter of Superbugs Resistant to All Antibiotics,” New York Times, May 27, 2016.

Only one-tenth of African countries: Margareth Ndomondo-Sigonda, Jacqueline Miot, Shan Naidoo, Alexander Dodoo, and Eliangiringa Kaale, “Medicines Regulation in Africa: Current State and Opportunities,” Pharmaceutical Medicine 31 (November 3, 2017): 383–97, doi:10.1007/s40290-017-0210-x.

CHAPTER 27: FLIES TOO NUMEROUS TO COUNT

In the blog post, Lal: Altaf Ahmed Lal, “FDA in India: Going Global, Coming Home,” FDA Voice, September 24, 2013.

America’s patients had: Within a year of Peter Baker’s inspection at Wockhardt, the company began a series of recalls of the drug. Eric Palmer, “Wockhardt Again Recalls Generic of AstraZeneca Drug after It Fails Testing,” FiercePharma (blog), September 2, 2014.

Harry Lever, the Cleveland Clinic cardiologist, had sent a detailed letter of concern: Dr. Harry M. Lever to Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA, December 12, 2012.

Lever received a detailed response: Lawrence Yu, “FW: Metoprolol Response,” email to Harry Lever, MD, December 19, 2012.

Dipesh Shah and Atul Agrawal, had arrived two days earlier: FDA, “Establishment Inspection Report,” Wockhardt Ltd., Aurangabad, Maharashtra, India, July 22–31, 2013.

labeled “Default May 2013”: Ibid., 14.

The man begged him: Ibid., 21.

import restrictions to the company: Wockhardt issued a statement after the FDA’s July 2013 inspection and import alert at its Chikalthana plant. The company made assurances that it had “already initiated several steps to address the observations made by the USFDA and shall put all efforts to resolve the matter at the earliest.” “Wockhardt’s Chikalthana Plant Hit by USFDA Import Restrictions,” Economic Times. November 27, 2013, https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/wockhardts-chikalthana-plant-hit-by-usfda-import-restrictions/articleshow/26466331.cms (accessed December 8, 2018).

In the early hours of a Sunday morning: FDA, “Establishment Inspection Report,” Ranbaxy Laboratories Ltd., Toansa, Punjab, India, January 5–11, 2014.

“flies TNTC” (too numerous to count): Ibid., 33.

as one FDA official later described it: The FDA official, Tom Cosgrove, called the finding “shocking” at an industry conference. “International Pharmaceutical Quality: Inside the Global Regulatory Dialogue.: Lecture, 2015, https://www.ipqpubs.com/wp-content/uploads/2015/06/Cosgrove-box.pdf (accessed February 10, 2019).

restricted from the U.S. market: Barbara W. Unger, “Does an FDA Import Alert Automatically Equate to an Impending FDA Warning Letter?” FDAzilla.com (blog), April 30, 2016, https://blog.fdazilla.com/2016/04/does-an-fda-import-alert-automatically-equate-to-an-impending-fda-warning-letter/ (accessed December 7, 2018).

Forty years of national reports: Over the years, numerous reports by Indian drug experts have castigated the state of drug regulation in India. The most recent reports include: Government of India, Ministry of Health and Family Welfare, Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues Including the Problem of Spurious Drugs, November 2003; Rajya Sabha, Parliament of India, Fifty-Ninth Report on the Functioning of the Central Drug Standard Control Organisation (CDSCO), May 2012; Report of the Prof. Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials, and Banning of Drugs, July 2013.

“If I have to follow U.S. standards”: Sushmi Dey, “If I Follow U.S. Standards, I Will Have to Shut Almost All Drug Facilities: G. N. Singh Interview with Drug Controller General of India,” Business Standard, January 30, 2014, https://www.business-standard.com/article/economy-policy/if-i-follow-us-standards-i-will-have-to-shut-almost-all-drug-facilities-g-n-singh-114013000034_1.html (accessed June 18, 2018).

superior to those of any other nation: The FDA’s internal battles over mutual recognition are documented in employee interviews in the FDA History Office’s oral history program. For more details, see the oral histories of: Walter M. Batts, “History of the Food and Drug Administration,” interviewed December 13 and 20, 2011; Stephanie Gray, “History of the Food and Drug Administration,” interviewed April 11, 2000; Linda Horton, “History of the Food and Drug Administration,” interviewed December 28, 2001; Gerald “Jerry” E. Vince, “History of the Food and Drug Administration,” interviewed December 2, 1998; and Andrew Von Eschenbach, “History of the U.S. Food and Drug Administration,” interviewed September 15, 2013.

“Statement of Intent,” a four-page document: Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, and Keshav Desiraju, Secretary of India’s Department of Health and Family Welfare, signatories to “Statement of Intent between the Food and Drug Administration of the United States of America and the Ministry of Health and Family Welfare of the Republic of India on Cooperation in the Field of Medical Products,” New Delhi, India, February 10, 2014.

The Ranbaxy executive took that moment to lobby: Gardiner Harris, “Medicines Made in India Set Off Safety Worries,” New York Times, February 14, 2014, https://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html (accessed June 18, 2018).

G. N. Singh shot back: Sumeet Chatterjee and Zeba Siddiqui, “UPDATE 1—U.S. Regulator on India Visit Calls for Greater Drug Safety Collaboration,” Reuters, February 18, 2014, https://www.reuters.com/article/fda-hamburg-india/update-1-u-s-regulator-on-india-visit-calls-for-greater-drug-safety-collaboration-idUSL3N0LN38W20140218 (accessed June 18, 2018).

CHAPTER 28: STANDING

had maligned him to journalists: “Some Brands of Nationalism Can Be Injurious to Your Health!” Governance Now, March 8, 2016, https://www.governancenow.com/news/regular-story/some-brands-nationalism-can-be-injurious-your-health (accessed December 16, 2018).

Thakur sent Vardhan: Dinesh S. Thakur, Executive Chairman, Medassure, to Honorable Dr. Harsh Vardhan, Minister of Health and Family Welfare, Government of India, October 19, 2013.

a “snake pit of vested interests”: Pritha Chatterjee, “MCI Corrupt, Clinical Trials Body a Snake Pit: Harsh Vardhan,” Indian Express, July 18, 2014.

caught their attention: Richard Preston Mason, Robert F. Jacob, and Seth A. Gerard, “Atorvastatin Generics Obtained from Multiple Sources Worldwide Contain a Methylated Impurity That Reduces Their HMG-CoA Reductase Inhibitory Effects,” Journal of Clinical Lipidology 7, no. 3 (2013).

drew defensive attacks from the FDA: Dr. Preston Mason’s findings about low-quality generic Lipitor appeared in the May/June 2013 issue of the Journal of Clinical Lipidology—just six months after Ranbaxy’s recall of its own generic Lipitor product due to the presence of tiny glass particles. The FDA reacted defensively to Mason’s study. During an interview with a Bloomberg reporter, CDER director Janet Woodcock claimed that Mason’s team didn’t use proper testing methods and therefore contaminated its own samples. Woodcock later repeated this attack in a paper cowritten with Mansoor A. Khan, “FDA Analysis of Atorvastatin Products Refutes Report of Methyl Ester Impurities,” Therapeutic Innovation and Regulatory Science 48, no. 5 (May 27, 2014): 554–56, doi:10.1177/2168479014536567. However, Mason had used the same testing method prescribed by the USP to test all his samples, and the methylated impurities that Woodcock claimed were proof of improper testing appeared only in some. Documents supporting this narrative include: Mason et al., “Atorvastatin Generics Obtained from Multiple Sources Worldwide Contain a Methylated Impurity That Reduces Their HMG-CoA Reductase Inhibitory Effects,” 287; Anna Edney, “Disputing Study, U.S. FDA Says Generics from Abroad Safe,” Bloomberg, March 25, 2014, http://www.bloomberg.com/news/articles/2014-03-25/disputing-study-u-s-fda-says-generics-from-abroad-safe (accessed July 13, 2018).

“Zero Defect, Zero Effect”: Vishwa Mohan, “PM’s Slogan: Zero Defect, Zero Effect,” Times of India, August 16, 2014.

suspending from the European market: B. V. Mahalakshmi, “EU Bans 700 Generic Drugs for Manipulation of Trials by GVK,” Financial Express, July 26, 2015.

a former employee of GVK Biosciences: On May 6, 2012, the whistleblower, Konduru Narayana Reddy, using the pseudonym “People Safety,” wrote an email to drug regulators in France, Britain, the United States, Austria, and the World Health Organization with the subject line “Regulatory Violations and Misconduct of Bioequivalence and Bioavailability Studies for the Past 5 Years by Head-Bio Analytical (V. Chandra Sekhar), GVK Biosciences Private Limited, CRO (India Based-Hyderabad).”

LeBlaye laid out his findings: ANSM (French Agency on Medicinal Products), Trials and Vigilance Inspection Department, “Final Inspection Report: Investigation of the Clinical Part of Bioequivalence Trials, with a Specific Focus on Electrocardiograms, May 19–23, 2014, GVK Biosciences,” July 2, 2014.

“bigger game being played out here”: Vidya Krishnan, “A Love Story That Cost GVK Its International Reputation,” The Hindu, October 9, 2015.

“Hold onto your hats! This is incredible”: Joe Graedon, “Hold onto Your Hats . . . This Is Incredible!,” email to Harry Lever, Erin Fox, Roger Bate, Preston Mason, and Dinesh Thakur, August 12, 2015.

They had crafted two lengthy petitions: Dinesh S. Thakur v. Union of India; Central Drug Standards Control Organisation, Drugs Consultative Committee, Comptroller and Auditor General of India (January 24, 2016); Dinesh S. Thakur v. Union of India (January 28, 2016).

had publicly attacked Thakur: Zeba Siddiqui, “Pharma Crusader Dinesh Thakur Takes India’s Drug Regulators to Court,” Reuters, March 7, 2016, https://www.reuters.com/article/india-pharma-whistleblower/pharma-crusader-takes-indias-drug-regulators-to-court-idUSKCN0W90C8 (accessed June 20, 2018).

he posted what he’d written, with the headline: Dinesh Thakur, “A Sincere Attempt to Improve the Quality of Medicine for People around the World,” Dinesh Thakur (blog), March 11, 2016, http://dineshthakur.com/?s=A sincere attempt to improve the quality of medicine for people around the world&x=0&y=0 (accessed June 20, 2018).

“From what little I have read”: Dinesh Thakur, “FDC Ban,” email to K. L. Sharma, March 23, 2016.

EPILOGUE

Kobe Steel, a Japanese steel maker: Jonathan Soble and Neal E. Boudette, “Kobe Steel’s Falsified Data Is Another Blow to Japan’s Reputation,” New York Times, October 10, 2017, https://www.nytimes.com/2017/10/10/business/kobe-steel-japan.html (accessed June 9, 2018).

column for an online publication, The Wire: Dinesh Thakur, “Lessons from Ranbaxy: Suffocating Silence Prevented Us from Questioning the Rot in the System,” The Wire, February 19, 2018, https://thewire.in/business/ranbaxy-suffocating-silence-prevented-us-questioning-rot-system (accessed June 9, 2018).

G. N. Singh, was removed from his job: Zachary Brennan, “India’s Drug Regulator Sees Top-Level Shakeup,” Regulatory Affairs Professionals Society, February 21, 2018, https://www.raps.org/news-and-articles/news-articles/2018/2/india’s-drug-regulator-sees-top-level-shakeup (accessed June 9, 2018).

the Ranbaxy company no longer exists: Though Ranbaxy Laboratories ceased to exist when it was acquired by Sun Pharma on March 25, 2015, Sun Pharma has continued to sell Ranbaxy-branded generics in markets where they were popular. Documents describing these events include: Sun Pharma, “Sun Pharma Announces Closure of Merger Deal with Ranbaxy,” news release, March 25, 2015, https://www.sunpharma.com/sites/default/files/docs/Press%20Release%20-%20Closure%20of%20Sun%20Pharma%20&%20Ranbaxy%20merger.pdf; Malvika Joshi and C. H. Unnikrishnan, “Sun Pharma to Retain Ranbaxy Brand Wherever It’s Strong,” LiveMint, April 10, 2014, https://www.livemint.com/Companies/rSdzvCSLvJesbEaSzgawVJ/Sun-Pharma-to-retain-Ranbaxy-brand-wherever-its-strong.html (accessed July 27, 2018); “Ranbaxy’s Journey as a Company to End after Merger with Sun,” Hindu BusinessLine, April 20, 2014, https://www.thehindubusinessline.com/companies/ranbaxys-journey-as-a-company-to-end-after-merger-with-sun/article20756422.ece# (accessed July 27, 2018); Sun Pharmaceutical Industries Ltd., “Annual Report of Subsidiary Companies,” 2017–2018, http://www.sunpharma.com/investors/annual-report-of-subsidiary-companies (accessed July 27, 2018).

sold the tarnished company cheaply: Chang-Ran Kim and Zeba Siddequi, “India’s Sun Pharma to Buy Struggling Ranbaxy for $3.2 Billion,” Reuters, April 7, 2014, https://www.reuters.com/article/us-daiichi-sankyo-ranbaxy-sunpharma/indias-sun-pharma-to-buy-struggling-ranbaxy-for-3-2-billion-as-daiichi-sankyo-retreats-idUSBREA3600L20140407 (accessed June 9, 2018).

Daiichi Sankyo emerged victorious from its arbitration in Singapore: Prabha Raghavan, “Delhi High Court Upholds Daiichi’s Rs 3,500-Crore Arbitral Award against Singh Brothers,” Economic Times, February 2, 2018, https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/delhi-high-court-upholds-daiichis-rs-3500-crore-arbitral-award-against-singh-brothers/articleshow/62723186.cms (accessed June 9, 2018).

new allegations that they’d siphoned $78 million: Ari Altstedter, George Smith Alexander, and P. R. Sanjai, “Indian Tycoons Took $78 Million Out of Hospital Firm Fortis,” Bloomberg, February 9, 2018.

They also faced a similar allegation: Ari Altstedter, “Billionaire Singh Brothers Accused by New York Investor of Siphoning Cash,” Bloomberg, January 28, 2018, https://www.bloomberg.com/news/articles/2018-01-28/billionaire-singh-brothers-accused-in-lawsuit-of-siphoning-money (accessed June 9, 2018).

“unsustainable debt trap”: Arun Kumar, “Fortis Founder Shivinder Singh Drags Elder Brother Malvinder Singh to NCLT,” Economic Times, September 5, 2018.

that her sons enter mediation: ET Bureau, “Malvinder Singh and Shivinder Singh Ready for Mediation,” Economic Times, September 15, 2018.

faced a new and serious allegation: Generic Pharmaceuticals Pricing Antitrust Litigation, Plaintiff States’ (Proposed) Consolidated Amended Complaint (Eastern District of Pennsylvania, October 21, 2017).

and possible cross-contamination between drugs: FDA, Establishment Inspection Report, Mylan Laboratories Ltd., Morgantown, West Virginia, March 19–April 12, 2018.

a response to the warning letter: Mylan N.V., “Mylan Statement in Response to FDA Warning Letter Relating to Morgantown Plant,” news release, November 20, 2018.

an extensive “multidisciplinary investigation”: Dr. John Peters, Director, Division of Clinical Review, Office of Generic Drugs, FDA, to Dr. Harry Lever, Medical Director, Hypertrophic Cardiomyopathy Clinic, March 31, 2014.

recalled their metoprolol succinate: Zeba Siddiqui, “Dr Reddy’s Recalls over 13,000 Bottles of Hypertension Drug—FDA,” Reuters, July 19, 2014.

had approved only a handful of visas: Adam Minter, “Is China Blocking FDA Inspectors?” Bloomberg, February 28, 2014.

the man “began running and fled the laboratory premises”: FDA, “Form 483: Inspectional Observations,” Zhejiang Hisun Pharmaceutical Co., Taizhou, China, March 2–7, 2015, 7.

Fifteen minutes later, a manager returned: FDA, “Warning Letter” to Zhejiang Hisun Pharmaceutical Co., Taizhou, China, December 31, 2015.

ended its partnership with Zhejiang Hisun: On November 10, 2017, roughly two and a half years after Baker’s inspection, Pfizer sold its 49 percent equity share in Hisun-Pfizer Pharmaceuticals, though it retained rights to manufacture, sell, and distribute the current and pipeline products that had resulted from the joint venture. Pfizer, “Pfizer Sells Its 49% Equity Share in Hisun-Pfizer Pharmaceuticals,” news release, November 10, 2017.

Baker went to Dalian in the Liaodong Peninsula: FDA, “Form 483: Inspectional Observations,” Pfizer Pharmaceuticals Ltd., Dalian, China, April 13–17, 2015.

There, too, he found: In response to the events at Dalian, a Pfizer spokesperson said, “Pfizer has responded and addressed the issues raised during the pre-approval inspection of our manufacturing site at Dalian. The issues cited in the FDA Form-483 do not indicate any quality or safety concerns and do not have any impact on products currently on the market manufactured at the Dalian site.”

where fraud was endemic: In 2016, an investigation by China’s own State Food and Drug Administration (SFDA) found that 80 percent of clinical trial data submitted by Chinese companies to regulators to gain approval for new drugs was fabricated. Fiona Macdonald, “80% of Data in Chinese Clinical Trials Have Been Fabricated,” Science Alert, October 1, 2016, https://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated (accessed September 30, 2018).

That, in turn, jeopardized FDA funding: In 1992, the Prescription Drug User Fee Act (PDUFA) permitted the FDA to collect fees from companies seeking approval for new drugs. Subsequent laws expanded the so-called “user fee” system to encompass the generic drug and medical device industries. Collectively, user fees now comprise about 40 percent of the FDA’s total budget. The system is not without critics, with some arguing that the revenue generated from user fees might limit the FDA’s ability to make impartial regulatory decisions. An FDA spokesperson said prescription drug user fees have helped the FDA to provide “timely review” of drug applications. J. Carroll, “PDUFA Faces Rough Reauthorization,” Biotechnology Healthcare (July 2007); see also Tara O’Neill Hayes and Anna Catalanotto, “Primer: FDA User Fees,” American Action Forum, August 22, 2017.

“shade the facts . . . increasingly uncomfortable”: Michael Mezher, “FDA Official Highlights Foreign Supply Chain Challenges,” Regulatory Affairs Professionals Society, May 5, 2017, https://www.raps.org/regulatory-focus™/news-articles/2017/5/fda-official-highlights-foreign-supply-chain-challenges (accessed June 9, 2018).

to make the final classifications less severe: In Zhejiang province, China, Bangli Medical Products held an FDA investigator hostage in its conference room, trapping her there for hours and demanding that she destroy the photographs she’d taken. It seemed clear to the FDA’s staff in China that the company had refused a for-cause inspection and its drugs needed to be blocked. An FDA supervisor wrote back to officials in Maryland: “Needless to say, they first refused the inspections and refused to recognize our investigator’s authority to inspect the premises. We need to immediately put this firm on import alert.” But an official at FDA headquarters quickly sounded a note of caution about “declaring that we have ‘authority’ in the foreign arena.” Another official weighed in, stating that it didn’t appear the plant manager who’d imprisoned the FDA’s investigator “was making a specified refusal.” The incident is documented in: Kelli Giannattasio, “Re: For Cause Inspection of Bangli Medical Products,” email to Susan F. Laska and Sherry Bous, July 27, 2016.

made by bureaucrats in Maryland: In a written statement, an FDA spokesperson explained, “The FDA can and does change assessments of a plant’s compliance. After the initial data gathered by the investigator is reviewed by both the Office of Regulatory Affairs and the Center for Drug Evaluation, additional information can be taken into account. Oftentimes, a firm is not able to provide paperwork at the time of an inspection but can produce documents later on that provide more insight into the matter. Assessments can also change based on how willing a firm is to cooperate and fix issues that are found.”

the agency lifted the restriction on about half of the drugs: E. J. Lane, “U.S. FDA Ingredient Exceptions from Banned Zhejiang Hisun Plant Draw Scrutiny,” FiercePharma, July 25, 2016, https://www.fiercepharma.com/pharma-asia/u-s-fda-ingredient-exceptions-from-banned-zhejiang-hisun-plant-draw-scrutiny (accessed June 9, 2018).

but the agency downgraded that to VAI: Tamara Felton Clark, Branch Chief, Global Compliance Branch 4, “Reclassification of Surveillance Inspection: VAI as Inspection Classification,” CMS File—Work Activity 161861, Zheijiang Huahai Pharmaceutical Co., Ltd. (FEI 3003885745), September 7, 2017.

the FDA would notify India’s companies in advance: Mathew Thomas, Dean Rugnetta, Solomon Yimam, Daniel Roberts, and Shiva Prasad, “Office of International Programs, U.S. FDA India Office (INO) Meeting Minutes,” proceedings of FDA, IPA, CDSCO meeting, India International Centre, New Delhi, November 3, 2016. Internally, FDA officials had abruptly stopped the India pilot program, and the short- and no-notice inspections in July 2015 but notified Indian companies sixteen months later. In 2018, when asked by a journalist why the FDA stopped the program, an agency spokesperson responded in a written statement, “After evaluation of the pilot a decision was made to discontinue the pilot.”