Tag Archives: FDA

FDLI Webinar on Regulation of Cannabis-Derived Products

by Bridget C.E. Dooling — Friday, Aug. 2, 2019@BridgetDooling

This week I moderated a webinar at the Food & Drug Law Institute (FDLI) on the regulation of cannabis-derived products. This is a product & policy area that’s evolving as I type. Just this week, former FDA Commissioner Scott Gottlieb wrote an op-ed acknowledging the consumer “craze” for products with CBD in them and encouraging FDA […]

Case To Watch: Eagle v. Azar’s Hidden Chevron-Step-1 Issue

by Erika Lietzan — Tuesday, May 14, 2019@lietzan

(Cross posted from Objective Intent) Recently I spoke at the annual meeting of the Food and Drug Law Institute (FDLI) on Eagle v. Azar, which is currently on appeal to the D.C. Circuit.  At first blush the case seems of limited importance, because Eagle Pharmaceuticals is simply challenging FDA’s interpretation of statutory language that has […]

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 […]