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JLME 45.4 Supplement Table of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF] (Free Download)
The Journal of Law, Medicine & Ethics always strives to be at the forefront of research and policy making. We aim to publish articles that reexamine and expand on the current literature and that create a path forward in medicine, law, ethics, and the many other sub-fields in health and health law. We hope every article we publish contributes to the voluminous literature in a positive way and that our readers are invigorated by the spirited discussion. This supplement issue of JLME continues this multi-disciplinary approach with "Blueprint for Transparency at the U.S. Food and Drug Administration." Here guest editors Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein, and Aaron S. Kesselheim and their co-authors have tackled the challenging topic of transparency at the respected government agency. A team of researchers from various universities wrote the main "Blueprint" article of this supplement issue, which is followed by six commentary articles. The Blueprint article recommends 18 specific ways the FDA can be more transparent so that the public at large can be better informed about medical products, applications, and scientific studies. The commentary articles then discuss what may work, the missed opportunities and limitations of the suggestions, and legal approaches and guidelines for the FDA to take. Ultimately, the hope is that the FDA will disclose more throughout its review process, and do so without disrupting trade secrecy protections, in order to improve the public's health.
Introductions
JLME 45.4 Supplement Introduction
Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein, and Aaron S. Kesselheim - [PDF] (Free Download)
Patients are angry that a once-promising drug in development has disappeared without a trace. Companies wait before developing a generic drug because they do not know how many others are in the pipeline. Physicians express frustration at company statements misrepresenting the data about a medication. In each of these scenarios, key information that could resolve the issue may have been transmitted to the U.S. Food and Drug Administration (FDA), but manufacturers' efforts to maintain confidentiality protections and the FDA's current disclosure rules supporting those claims keep the information from the public eye. Can the FDA take better approaches to transparency that can simultaneously support the public health and not undermine appropriate recognition of trade secrets?
Symposium Articles
Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products
Joshua M. Sharfstein, James Dabney Miller, Anna L. Davis, Joseph S. Ross, Margaret E. McCarthy, Brian Smith, Anam Chaudhry, G. Caleb Alexander, and Aaron S. Kesselheim - [PDF] (Free Download)
The U.S. Food & Drug Administration (FDA) stands apart among the world's regulatory agencies for the depth of its expertise and analysis about medical products. However, much of this knowledge and information about the regulatory process stay within FDA's walls, as a result of policies and regulations that have for many years broadly defined what is considered "confidential."
Transparency at the U.S. Food and Drug Administration
Robert M. Califf - [PDF] (Free Download)
The U.S. Food and Drug Administration's (FDA) activities have enormous and wide-ranging effects on the economy and health of America and the world as a whole. The degree to which its activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. The current status quo reflects more than a century's accumulation of laws, regulations, guidances, court decisions, practical precedent, and philosophical tradition. However, given significant changes in the environment in which the FDA now operates, it is reasonable to critically examine the basis for current practices. The "Blueprint for Transparency" calls for a host of specific actions to increase transparency across five major areas.
FDA Transparency in an Inescapably Political World
Daniel Carpenter - [PDF] (Free Download)
With multidisciplinary collaboration across four stellar institutions and with wise, forward-looking support from the Arnold Foundation, the Food and Drug Administration (FDA) Transparency Working Group has produced a thoughtful and useful report. I congratulate the academics for having moved the debate forward and for having produced a nuanced and balanced, yet concise analysis that offers concrete, implementable recommendations.
Clinical Trial Transparency: The FDA Should and Can Do More
Amy Kapczynski and Jeanie Kim - [PDF] (Free Download)
In recent years, the scientific community and regulators have increasingly recognized the value of data transparency in clinical research. Adding to this momentum, the Blueprint for Transparency at the FDA calls upon the U.S. Food and Drug Administration to act as a key intermediary for sharing clinical trial data. We strongly support the Blueprint's recommendations for the FDA to proactively release substantially more pre-market and post-market clinical trial data submitted by companies. The FDA is in a particularly good position to facilitate public disclosure of data. Tasked with comprehensively regulating the drugs, devices, and biologics on the U.S. market, the agency has access to a wealth of clinical trial data and receives more data than its European counterpart. Notably, the recently appointed FDA Commissioner Scott Gottlieb has expressed his support for data transparency, acknowledging that the agency should leverage its regulatory authority to release data in the public's interest.
FDA and the Marketplace of Ideas for Medical Products
Nathan Cortez - [PDF] (Free Download)
Modern free speech law is predicated on an analogy. Just as superior products and services will prevail in a free and open market, so too superior ideas (and ideally, the truth) will prevail in a free and open "marketplace of ideas." Inspired by laissez-faire economics, the analogy suggests that free expression, with minimal government interference, will generate the best ideas and the most truth.
Disclose Data Publicly, without Restriction
Peter Doshi and Tom Jefferson - [PDF] (Free Download)
The FDA holds more clinical trial data than any other body on the planet, more than any other regulator and more than any single pharmaceutical company. And at present the FDA sits on those data, treating such data as commercial confidential information that it is not at liberty to disclose. This prevents systematic reviewers, guideline committees, other public health bodies, and other third parties from independent evaluation of the clinical evidence the FDA relied upon to determine the benefits and harms of medicines. In other words, 'no sunlight please - we know what is best for you.' This must end, and the Blueprint rightly calls on FDA to "disclose data from scientific studies to enhance understanding of medical products."
Withholding Information on Unapproved Drug Marketing Applications: The Public Has a Right to Know
Sammy Almashat and Michael Carome - [PDF] (Free Download)
The U.S. Food and Drug Administration (FDA) is a critical public health agency that regulates drugs, medical devices, food, cosmetics, and tobacco products, which together amount to one-fifth of all U.S. economic activity. However, much of the information upon which the agency relies when making pivotal regulatory decisions with regard to such products is withheld from the public.