Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Notice & Comment 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 funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

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Supporting FDA Product Reviews with User Fees Alone

Cross Posted on Notice and Comment.

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 for medical product user fee programs to be 100 percent user-fee supported.

Congress structures agency user fee provisions many different ways, and the current approach to medical product user fees is complex and unusual. Among other things, it ensures that annual appropriations play a role in supporting review activities. This means the Administration’s proposal would require revision of the bills currently winding their way through the legislative process.

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FDA Highlights from the Health Law Profs Conference

Last week, the American Society of Law, Medicine & Ethics held its annual Health Law Professors conference—and my own institution, Georgia State University College of Law, had the pleasure of hosting the conference.

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Demystifying Drug Importation after Impression v. Lexmark

(Cross-posted on PatentlyO.)

On May 30, the Supreme Court surprised many of us by ruling that exhaustion of U.S. patent rights occurs even when sale of the item takes place in a foreign country.  There is a great deal more to the ruling, and there are now very interesting questions about the characterization of transactions as something other than “sales” and about the use of contractual provisions to prevent resale into the United States following first sale of patented products elsewhere.  But for now, let’s stop with the bare bones description: U.S. patent rights are exhausted when an item is sold overseas.  This means that shipping an already-sold product into the United States for subsequent-sale to a U.S. consumer will not infringe the patents in question.  Depending on how patent owners structure their transactions overseas going forward, this ruling could give U.S. consumers access to products that are intended for foreign markets and that are priced for those markets — lower, for instance.

One of the many topics circulating now: what are the implications for pharmaceutical companies and for U.S. consumers of pharmaceuticals

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Welcome to Objective Intent!

We are delighted to introduce Objective Intent, a blog in which we explore legal and policy issues associated with the U.S. Food and Drug Administration (FDA).  The FDA is an important and (we think) particularly interesting agency that has broad powers to achieve its public health mission and jurisdiction over roughly 25% of the consumer economy.  As some readers will know, the title of our blog, “Objective Intent,” comes from FDA regulations that define “intended use.” This title both pays homage to the critical role that a product’s intended use plays in many FDA controversies and reflects our hope that this blog will serve as a space for objective reflection on FDA issues by legal academics.