Affiliations listed are those held at the approximate time characters appear in the book. Dates have been included for titles held by multiple characters. The names of some FDA divisions have since changed due to government reorganization.
DRUG COMPANIES
Ranbaxy
MANAGING DIRECTORS
Arun Sawhney, CEO and managing director, 2010–2015
Atul Sobti, CEO and managing director, 2009–2010
Malvinder Singh, CEO and managing director, 2006–2009
Shivinder, brother
Brian Tempest, CEO and managing director, 2004–2005
Davinder Singh “D.S.” Brar, CEO and managing director, 1999–2004
Parvinder Singh, chairman and managing director, 1992–1998; joint managing director, 1976–1991, with his father, Bhai Mohan
Bhai Mohan Singh, chairman and joint managing director, 1976–1991; chairman and managing director, 1961–1975
RESEARCH AND DEVELOPMENT
Rajinder “Raj” Kumar, director, 2004–2005
Rashmi Barbhaiya, director, 2002–2004
Rajiv Malik, head of formulation development and regulatory affairs
Arun Kumar, associate director of regulatory affairs
Dinesh Thakur, director and global head of research information & portfolio management
Sonal Thakur, wife
Andrew Beato, attorney at Stein, Mitchell, Muse & Cipollone LLP
U.S. BUSINESS
Jay Deshmukh, senior vice president of global intellectual property
Abha Pant, vice president of regulatory affairs
OUTSIDE LAWYERS AND CONSULTANTS
Kate Beardsley, partner, Buc & Beardsley
Christopher Mead, partner, London & Mead
Warren Hamel, partner, Venable LLP
Agnes Varis, consultant
Cipla Limited
Yusuf “Yuku” Khwaja Hamied, chairman and managing director
Khwaja Abdul “K.A.” Hamied, founder
Daiichi Sankyo Company
Tsutomu Une, head of global strategy
Mylan N.V.
EXECUTIVES
Heather Bresch, CEO
Rajiv Malik, president
Deborah Autor, senior vice president, head of global strategic quality
INDIAN GOVERNMENT
Central Drugs Standard Control Organization
Gyanendra Nath “G.N.” Singh, drug controller general
Ministry of Health and Family Welfare
Harsh Vardhan, minister
U.S. GOVERNMENT
Congress
David Nelson, senior investigator, House Committee on Energy and Commerce
Food and Drug Administration
OFFICE OF THE COMMISSIONER
Scott Gottlieb, commissioner, 2017–present
Margaret Hamburg, commissioner, 2009–2015
OFFICE OF THE CHIEF COUNSEL
Marci Norton, senior counsel
Steven Tave, associate chief counsel for enforcement
CENTER FOR DRUG EVALUATION AND RESEARCH
Janet Woodcock, director
Robert Temple, deputy center director for clinical science
OFFICE OF COMPLIANCE
Deborah Autor, director
Thomas Cosgrove, director, Office of Manufacturing Quality
Carmelo Rosa, director, Division of International Drug Quality
Edwin Rivera-Martinez, chief, International Compliance Branch
Douglas Campbell, compliance officer
Karen Takahashi, compliance officer
OFFICE OF PHARMACEUTICAL SCIENCE
Office of Generic Drugs
Gary Buehler, director
OFFICE OF GLOBAL REGULATORY OPERATIONS & POLICY
Office of International Programs
FDA India Office
Altaf Lal, director
Atul Agrawal, supervisory consumer safety officer
Muralidhara “Mike” Gavini, senior assistant country director
Peter Baker, assistant country director
Regina Brown, international program and policy analyst for drugs
Office of Regulatory Affairs
Dedicated Drug Team
Jose Hernandez, investigator
Office of Criminal Investigations
Debbie Robertson, special agent
Department of Justice
OFFICE OF CONSUMER LITIGATION
Linda Marks, senior litigation counsel
U.S. ATTORNEY’S OFFICE, DISTRICT OF MARYLAND
Stuart Berman, assistant U.S. attorney
DOCTORS AND PATIENT ADVOCATES
Joe Graedon, cohost of the NPR program The People’s Pharmacy
William F. Haddad, generic drug advocate
Harry Lever, director, Hypertrophic Cardiomyopathy Center, Cleveland Clinic
Randall Starling, head, Section of Heart Failure and Cardiac Transplant Medicine, Cleveland Clinic
MANUFACTURING PLANTS
Fresenius Kabi
Kalyani, Nadia District, West Bengal, eastern India
Mylan
Morgantown, West Virginia, southeastern United States
Nashik, Nashik District, Maharashtra, western India
Pfizer
Dalian, Liaodong Peninsula, Liaoning Province, northeastern China
Ringaskiddy, County Cork, southern Ireland
Zhejiang Hisun (affiliate), Taizhou, Zhejiang, eastern China
Ranbaxy
Dewas, Dewas District, Madhya Pradesh, central India
Mohali, SAS Nagar District, Punjab, northern India
Ohm Laboratories, New Brunswick, New Jersey, northeastern United States
Paonta Sahib, Sirmour District, Himachal Pradesh, northern India
Toansa, Nawanshahar District, Punjab, northern India
Wockhardt
Chikalthana, Aurangabad District, Maharashtra, western India
Waluj, Aurangabad District, Maharashtra, western India