Monthly Archives: November 2012
Nov 30, 2012 Kathleen Boozang
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.
Nov 30, 2012 Michael Froomkin
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
Nov 30, 2012 Michael Froomkin
Jotwell: The Journal of Things We Like (Lots) seeks short reviews of (very) recent scholarship related to the law that the reviewer likes and thinks deserves a wide audience. The ideal Jotwell review will not merely celebrate scholarly achievement, but situate it in the context of other scholarship in a manner that explains to both specialists and non-specialists why the work is important.
Although gentle critique is welcome, reviewers should choose the subjects they write about with an eye toward identifying and celebrating work that makes an original contribution, and that will be of interest to others. First-time contributors may wish to consult the Jotwell Mission Statement for more information about what Jotwell seeks, and what it seeks to achieve.
Reviews need not be written in a particularly formal manner. Contributors should feel free to write in a manner that will be understandable to scholars, practitioners, and even non-lawyers.
Ordinarily, a Jotwell contribution will
- be between 500-1000 words;
- focus on one work, ideally a recent article, but a discussion of a recent book is also welcome;
- begin with a hyperlink to the original work — in order to make the conversation as inclusive as possible, there is a strong preference for reviews to focus on scholarly works that can be found online without using a subscription service such as Westlaw or Lexis. That said, reviews of articles that are not freely available online, and also of very recent books, are also welcome.
Currently, Jotwell particularly seeks contributions relating to:
We also have a Classics section, limited to reviews of works more than 50 years old. We intend to add more sections in the coming month
References
Authors are responsible for the content and cite-checking of their own articles. Jotwell editors and staff may make editorial suggestions, and may alter the formatting to conform to the house style, but the author remains the final authority on content appearing under his or her name.
- Please keep citations to a minimum.
- Please include a hyperlink, if possible, to any works referenced.
- Textual citations are preferred. Endnotes, with hyperlinks, are allowed if your HTML skills extend that far.
- Authors are welcome to follow The Bluebook: A Uniform System of Citation (19th ed. 2010), or the The Redbook: A Manual on Legal Style (2d Ed.) or indeed to adopt any other citation form which makes it easy to find the work cited.
Technical
Jotwell publishes in HTML, which is a very simple text format and which does not lend itself to footnotes; textual citations are much preferred.
Contributors should email their article, in plain text, in HTML, or in a common wordprocessor format (Open Office, WordPerfect, or Word) to jotwell@gmail.com and we will forward the article to the appropriate Section Editors. Or you may, if you prefer, contact the appropriate Section Editors directly.
Nov 29, 2012 Michael Froomkin
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.
We in the legal academy value originality. We celebrate the new. And, whether we admit it or not, we also value incisiveness. An essay deconstructing, distinguishing, or even dismembering another’s theory is much more likely to be published, not to mention valued, than one which focuses mainly on praising the work of others. Books may be reviewed, but articles are responded to; and any writer of a response understands that his job is to do more than simply agree.
Most of us are able to keep abreast of our fields, but it is increasingly hard to know what we should be reading in related areas. It is nearly impossible to situate oneself in other fields that may be of interest but cannot be the major focus of our attention.
A small number of major law journals once served as the gatekeepers of legitimacy and, in so doing, signaled what was important. To be published in Harvard or Yale or other comparable journals was to enjoy an imprimatur that commanded attention; to read, or at least scan, those journals was due diligence that one was keeping up with developments in legal thinking and theory. The elite journals still have importance – something in Harvard is likely to get it and its author noticed. However, a focus on those few most-cited journals alone was never enough, and it certainly is not adequate today. Great articles appear in relatively obscure places. (And odd things sometimes find their way into major journals.) Plus, legal publishing has been both fragmented and democratized: specialty journals, faculty peer reviewed journals, interdisciplinary journals, all now play important roles in the intellectual ecology.
The Michigan Law Review publishes a useful annual review of new law books, but there’s nothing comparable for legal articles, some of which are almost as long as books (or are future books). Today, new intermediaries, notably subject-oriented legal blogs, provide useful if sometimes erratic notices and observations regarding the very latest scholarship. But there’s still a gap: other than asking the right person, there’s no easy and obvious way to find out what’s new, important, and interesting in most areas of the law.
Jotwell fills that gap. We are not be afraid to be laudatory, nor do we give points for scoring them. Rather, we challenge ourselves and our colleagues to share their wisdom and be generous with their praise. We will be positive without apology.
Tell us what we ought to read!
How It Works
Jotwell is organized in sections, each reflecting a subject area of legal specialization. Each section, with its own url of the form sectionname.jotwell.com, is managed by a pair of Section Editors who have independent editorial control over that section. The Section Editors selecting a team of ten or more Contributing Editors. Each of these editors commits to writing at least one Jotwell essay of 500-1000 words per year in which they identify and explain the significance of one or more significant recent works – preferably an article accessible online, but we won’t be doctrinaire about it. Our aim is to have at least one contribution appear in each section every month, although we won’t object to more. Section Editors are also responsible for approving unsolicited essays for publication. The number of sections is not fixed, and is still growing.
For the legal omnivore, the ‘front page’ at Jotwell.com contains the first part of every essay appearing elsewhere on the site. Links take you to the full version in the individual sections. There, articles are open to comments from readers.
The Details
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