Tag Archives: FDA

The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

by Patti Zettler — Tuesday, July 18, 2017@pzettler

Cross-Posted on Objective Intent In January FDA published a controversial revision to its regulations defining a product’s “intended use” that, among other things, has raised an interesting logical outgrowth question. “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can […]

FDA Advisory Committees and Industry-Funded Patient Advocacy

by Patti Zettler — Friday, June 23, 2017@pzettler

Cross-posted on Objective Intent and Stanford’s Law and the Biosciences Blog. Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry […]

Supporting FDA Product Reviews with User Fees Alone

by Erika Lietzan — Saturday, June 17, 2017@lietzan

Cross Posted on Objective Intent. Budget documents released by the White House and FDA in May suggest the Administration intends to restructure medical product user fees, so that a greater percentage of the agency’s work is fully user fee funded.  The Secretary’s May 15 letter, explaining the President’s earlier Budget Blueprint, suggests the goal is […]

FDA User Fee Churn

by Erika Lietzan — Sunday, June 11, 2017@lietzan

(Cross posted from Objective Intent) This post is one of several this summer that will focus on the pending FDA user fee reauthorization legislation.  It starts with a basic introduction: what is “user fee reauthorization,” and why must it pass? The short version:  this summer we are talking about FDA’s medical product user fee legislation, […]

Public Health Groups Ask Court to Make FDA Do Its Job

by Micah Berman — Wednesday, Oct. 5, 2016

Eight public health groups, joined by three individual physicians, filed a lawsuit today asking a federal court to order the FDA to implement graphic health warnings for cigarettes. Quick background: The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) instructed to the FDA to promulgate a rule within two years that required graphic health […]

If There’s No Such Thing as Medical Marijuana, How Do We Have Medical Marijuana?

by Sam Halabi — Friday, Aug. 12, 2016

This week, the Drug Enforcement Agency (DEA) responded to petitions requesting a redesignation of marijuana for the benefit of scientific research. The DEA refused, citing, somewhat tautologically, the fact that there are no scientifically valid and well-controlled clinical trials demonstrating benefits for certain modalities of marijuana for specific medical indications.  DEA affirmed marijuana’s continued status […]

E-Cigarette Regulation: A Response to Adler et al.

by Micah Berman — Tuesday, July 5, 2016

Jonathan Adler (Case Western), Roger Meiners (Texas A&M), Andrew Morriss (UT-Arlington) and Bruce Yandle (Clemson) have co-authored Baptists, Bootleggers & Electronic Cigarettes, which is forthcoming in the Yale Journal on Regulation and has already been previewed online here and elsewhere. As the title suggests, this article applies the “Baptists & Bootleggers” theory of regulation to […]

Eminent Domain for Drugs

by Nicholas Bagley — Thursday, May 5, 2016

From his perch at Politico, Dan Diamond has launched what promises to be a terrific new health-policy podcast, Pulse Check, with an interview with CMS’s acting administrator, Andy Slavitt. The interview is refreshingly candid: among other things, Slavitt confesses that the Obama administration has a lot of work to do to win back the hearts […]

Premarket Review of Tobacco Products: The FDA’s Misplaced Priorities

by Micah Berman — Wednesday, Apr. 13, 2016

Along with colleagues at the Public Health Law Center, I published an article this week in the journal Tobacco Control that critically reviews the FDA’s implementation of its authority to regulate the sale of new tobacco products. In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), establishing federal authority to […]

FDA’s Memoranda of Understanding, Quasi-Treaties, and their Role in the Future of Global Administrative Law

by Sam Halabi — Monday, Feb. 8, 2016

In my last post, I detailed the kinds of agreements FDA uses with regulatory partners as part of a three-post series that examines FDA through the lens on the growing literature on “global administrative law.” This final post analyzes FDA’s “steepest” commitments with regulatory partners and argues that in the process of contributing to global […]

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