Monthly Archives: November 2012

January 2013 (1) »

Can the Power of the FDA Be Reprised?

Daniel Carpenter, Reputation and Power, Princeton University Press, 2010.

Harvard Professor Daniel Carpenter’s Reputation and Power epitomizes the best of academic scholarship.  While this review focuses on its substantive contributions to the health or life sciences professor, the theme of the book is actually much more significant – whether and how government bureaucracy can effectively contribute to the common good – which is the take reviewed by others.  For those who are not intimately familiar with the Food and Drug Administration and pharmaceutical regulation, reading Carpenter’s book significantly resolves this knowledge gap.  While I can’t disagree with David Zaring‘s observation that the book is “methodologically eclectic,” it is nonetheless an invaluable resource for students of drug regulation as well as the administrative state.

Carpenter’s opus provides a comprehensive history of each piece of legislation that contributed to the agency’s creation, describes how the responses to a few major drug safety crises, or what Carpenter calls “policy tragedies,” contributed both to the passage of key legislation and the FDA’s reputation, and posits that the agency’s reputation with its multiple constituencies is the key to its vast power. Ultimately, Carpenter is interested in how a government agency in a country that is anti-big government can be so trusted and hold such power over a multi-national industry. In concluding that the agency’s power derives from its reputation, Carpenter explores the relationship between the institution and those who populate it, paying tribute to the many FDA officials whose own ethical and scientific integrity created, maintained and were inextricably linked with the ethos for which the FDA is so respected.  According to Carpenter, Dr. Frances Oldham Kelsey of thalidomide fame was not unique in her commitment to the public’s interest, scientific rigor and tenacity; those characteristics were embedded in the agency and, by virtue of its power, necessarily transformed the pharmaceutical industry from a not-always trustworthy and sometimes sloppy enterprise into one that adheres to generally accepted scientific methods.

Carpenter’s observation that the status of the FDA in the U.S. is unique in a country generally suspicious of the regulatory state resonates as we exit from an election season largely focused on the philosophical divide about the role of government in society.  Carpenter reminds us of how extraordinary it is that an entire industry requires the imprimatur of a government agency before its products or advertisements may enter the marketplace, and that government may seize products already in the stream of commerce if deemed necessary to protect consumers.  The FDA’s reputation lead to the solidification of its power by other branches of government, most notably in the 1943 Supreme Court decision of United States v. Dotterweich.  Power and Reputation reinforces the notion of the tremendous scope of the FDA’s power by describing the numerous nations that emulate the FDA’s methodologies, structure, and assessments.  In short, Carpenter asserts that “the FDA rules the entire global pharmaceutical market.”  The key to the agency’s success, Carpenter believes, is its ability to inspire the trust that, despite being an agency of the government, the FDA ably protects the public.

As described by Carpenter, the history of how the FDA garnered its power, especially in the face of opposition from both the AMA and several of the power-house pharmaceutical companies, is fascinating, posing the obvious question of whether it would be possible to recur in the United States.  The public’s ambivalence about environmental science, as well as Congress’s treatment of FDA jurisdiction over tobacco-related products, medical devices, food and dietary supplements suggests not.  Also instructive is Carpenter’s description of how the FDA strategically aligned itself with academics to raise the bar on its own scientific standards, thereby necessitating that industry also expand its scientific capacity.  That the agency’s focus on the scientific method and demands for extensive data ultimately contributed to its trustworthiness is somewhat ironic as we struggle with the consequences of the politicization of science in so many regulatory domains today.  That the FDA obtained its reputation by close work with academic scientists, and stayed ahead of emerging developments, provides an interesting juxtaposition to former FDA Commissioner von Eschenbach’s recently expressed concerns in the Wall Street Journal that insufficient resources and fear of criticism from consumer groups have interfered with the FDA’s ability to work collaboratively with researchers developing new technologies so that they are able “to craft standards for evaluating new technologies while they are still being developed.”

Objections to the FDA’s attempts to eliminate proprietary medicines and quackery more generally remind one of current debates about complementary and alternative medicine and even libertarian views about the FDA’s role more generally, as evidenced by the Washington Legal Foundation’s position in the Abigail Alliance case.  The FDA’s early twentieth century moves against patent medicines were met with charges that it was undermining the “right of self-medication” which encompassed the “absolute liberty of the consumer or patient to purchase any and all medications for the amelioration of his or her ailments.”  These objectors did support labeling requirements that would allow the “intelligent layman” to make informed decisions about their pharmaceutical purchasing.

Also intriguing from an historical perspective is to encounter yet another example in which the AMA fights on the losing side of a major piece of social legislation.  Perceiving that the powers sought by the FDA would interfere with physicians’ decision-making autonomy, the AMA objected both to FDA-enhancing legislation, and the expansion of non-MD pharmacology, despite “the average physicians’ incapacity to assess the quality and hazards of drug treatments.”  We are likely once again entering an era where the sophistication of certain drugs and medical devices should limit their use to specific highly trained physicians – whether this evolves through the market, professional self-regulation, government regulation or the tort system will be interesting to watch.

The study of the power and influence of the FDA reminds us that we continue to struggle over the policy questions regarding the ideal scope of government authority over the pharmaceutical industry.  Carpenter notes that, even though public disgruntlement about drug company profit margins and “spiraling medical inflation” persist from one century to the next, the FDA has historically and shrewdly side-stepped drug pricing issues, leaving the debate about “socialized medicine” to Congress. In comparing the FDA with its European counterparts, Carpenter also suggests that comparative effectiveness analysis is gradually occurring in the United States.  The pressures for life-saving drugs created by the AIDS crisis created the template for disease politics and upped the pressure for the FDA to approve new drugs more quickly, and time will tell whether this is to the detriment of the agency’s mission.

Carpenter’s history recounts the frequently-heard criticisms of the FDA as being both too restrictive and insufficiently protective of consumer safety, and that certainly remains the case today.  According to some contemporary critics, conflicts of interest by appointees to FDA review panels and the payment of user fees by companies whose products are under review also threaten another historic FDA strength identified by Carpenter: FDA freedom from industry capture. Unsurprisingly, these claims are controversial, with FDA critics such as Richard Epstein charging that consumer advocates have persuaded Congress to shackle the FDA with excessive regulations and made it cripplingly risk adverse.

This book is a must- and easy read, irrespective of whether you teach an FDA course.  Its lessons about the administrative state when it is as its best and worst are instructive to any student of public policy, but especially to those of us dedicated to the public’s health.

 

 
 

Meet the Editors

Health Law Section Editors

The Section Editors choose the Contributing Editors and exercise editorial control over their section. In addition, each Section Editor will write at least one contribution (“jot”) per year. Questions about contributing to a section ought usually to be addressed to the section editors.


Professor Kathleen Boozang
Seton Hall School of Law


Professor Elizabeth Weeks Leonard
University of Georgia School of Law

Contributing Editors

Contributing Editors agree to write at least one jot for Jotwell each year.


Professor Nathan Cortez
SMU Dedman School of Law


Professor Mary Crossley
University of Pittsburgh School of Law


Professor Thomas Greaney
Chester A. Myers Professor of Law
SLU School of Law


Professor Nicole Huberfeld
Gallion & Baker Professor of Law
University of Kentucky College of Law


Professor Timothy Stoltzfus Jost
Robert L. Willett Family Professor of Law
Washington and Lee University School of Law


Professor Kristin Madison
Professor of Law and Health Sciences
Northeastern University School of Law


Professor Amy Monahan
Solly Robbins Distinguished Research Fellow
University of Minnesota Law School


Professor Abigail Moncrieff
Peter Paul Career Development Professor
Boston University School of Law


Professor David Orentlicher
Samuel R. Rosen Professor of Law
Indiana University, Robert H. McKinney School of Law


Professor Christopher Robertson
University of Arizona, James E. Rogers College of Law

 
 

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The Journal of Things We Like (Lots)–JOTWELL–invites you to join us in filling a telling gap in legal scholarship by creating a space where legal academics can go to identify, celebrate, and discuss the best new legal scholarship. Currently there are about 350 law reviews in North America, not to mention relevant journals in related disciplines, foreign publications, and new online pre-print services such as SSRN and BePress. Never in legal publishing have so many written so much, and never has it been harder to figure out what to read, both inside and especially outside one’s own specialization. Perhaps if legal academics were more given to writing (and valuing) review essays, this problem would be less serious. But that is not, in the main, our style.

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