R. ALTA CHARO
We have an opportunity for everyone in the world to have access to all the world’s information. This has never before been possible. Why is ubiquitous information so profound? It’s a tremendous equalizer. Information is power.
—GOOGLE EXECUTIVE CHIEF ERIC SCHMIDT, 2009 COMMENCEMENT ADDRESS AT THE UNIVERSITY OF PENNSYLVANIA
DRUG SAFETY communication, obstacles to manufacturing innovation, and the DESI experience. Three topics that appear quite distinct. But threading through them are observations about the control of information, the importance of disclosure, and the power to pronounce the truth.
The real regulatory power of the U.S. Food and Drug Administration (FDA) lies in its power to pronounce the truth. Its enabling statutes prohibit marketing adulterated or misbranded drugs and require them to undergo a premarket review by FDA. As of 1938, any drug that has not been proven to FDA to be safe is presumed to be unfit for its intended purpose and therefore is misbranded and not marketable. As of 1962, FDA must be persuaded of the drug’s effectiveness as well. That the sponsor or any third-party evaluator might conclude that the drug in fact is safe and effective, and entirely fit for its intended use, is not sufficient. This must be proven as well and declared by FDA before marketing is permitted. In that sense, FDA owns the power to pronounce on the truth of the drug’s fitness.
Carpenter, Greene, and Moffitt’s chapter, “The Drug Efficacy Study Initiative and Its Manifold Legacies,” describes the mid-twentieth-century regulatory land grab for control of truth, when drugs were now required to prove efficacy to FDA, even if they had long been on the market. While sponsors and consumers might have formed their own judgments about the effectiveness of these drugs, FDA now had the exclusive authority to make that determination, which it did through the Drug Efficacy Study Initiative (DESI). FDA was not required to prove the “truth” to a third party in a drug-by-drug adjudicatory proceeding but could make sweeping categorical determinations through rulemaking and publication in the Federal Register. Thus, the power to declare the truth of a claim of efficacy shifted from manufacture to government.
Moving forward in time to the end of the twentieth century, Geoffrey Levitt’s chapter, “Drug Safety Communication: The Evolving Environment,” describes the decentralization of drug safety information gathering and reporting and asks how this will affect control of truthful information. Pointing to the experience with Vioxx, he describes the decline of trust in the sponsor–regulatory dyad and the move to more transparency about clinical trial results or even patient-level data. But while multiple third-party analyses may yield new insights that were missed or omitted by the sponsor, they undermine FDA’s power to declare what is “true” and risk creating confusion for the public and the practitioners.
Nicholson Price’s chapter, “Innovation Policy Failures in the Manufacturing of Drugs,” looks not at truth itself so much as at the effects of disclosing it. For pharmaceuticals, the intellectual property incentives are sufficient to overcome the barriers to market entry. For manufacturing, however, the disclosure requirements associated with patents discourage innovation because it is easy to “invent around” a process and hard to identify or prosecute copycats. The resulting preference for trade secrets helps the pioneer but slows innovation by others, who must now develop processes wholly from scratch. With patents, disclosure rules mean control of information shifts from inventor to the public. With manufacturing process trade secrets, however, control of information remains entirely in the hands of the manufacturer, to the detriment of the public’s interest in newer, better methods.
It is often said that we live in the information age. But perhaps it is more to the point to say that we live in the age of grassroots information, decentralized information, and ubiquitous information. It calls to mind the revolution occasioned by the printing press, which allowed the spread of learning beyond the narrow confines of monasteries and castles, ultimately helping to empower both the laity and the middle class.
In America, disclosure and transparency are the watchwords, and distrust of authority and expertise is the new clarion call. Whether in the growing legal tolerance for off-label promotion or the movement to disclose research data, there is a culture of crowd-sourcing truth. The 1962 Kefauver-Harris Amendments and the DESI experience may well represent the last major regulatory successes at owning pharmaceutical truth. And with innovation a primary goal of contemporary economic policy, the trade secrets of drug manufacturers may well represent a dying form of commercial ownership of information. But with transparency, disclosure, and democratization of truth comes the challenge of interpretation and responsible use of information.
Information paints no picture, sings no song, and writes no poem.
—R. F. GEORGY, NOTES FROM THE CAFÉ (2014)
