FDA Law SSRN Reading List – October and November (Part 2 of 2)

Here are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.

Continue reading “FDA Law SSRN Reading List – October and November (Part 2 of 2)”

FDA Law SSRN Reading List – October and November (Part 1 of 2)

Here is what is new and interesting from the last two months.  I’ll start with two articles on off-label promotion and two articles relating to tobacco regulation.

Continue reading “FDA Law SSRN Reading List – October and November (Part 1 of 2)”

Thoughts on “Reciprocal Marketing Approval”

On October 26, Senator Cruz introduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017” (S. 2022), which is interesting from an FDA law perspective as well as an administrative law perspective.  We have seen this proposal before — in 2015 (S. 2388, introduced by Senator Cruz) and in 2016 (H.R. 6241, introduced by Congressman DeSantis).  Rachel Sachs wrote about it from a policy perspective in December 2015, and Zach Brennan offered more details in his own piece the same month.  I am going to dig into the details a bit more than they did and explain why I call it the “Send All the FDA Employees Home Act of 2017.”

Continue reading “Thoughts on “Reciprocal Marketing Approval””

FDA Law SSRN Reading List (September 2017)

Here’s what to read on SSRN, relating to FDA law, from September 2017.  One piece contributes to a growing literature on the relationship between inter partes review and Hatch-Waxman litigation, and one piece dives into application of intended use doctrine to synthetic nicotine products.

Continue reading “FDA Law SSRN Reading List (September 2017)”

Hatch-Waxman Comments – Status Report (Part II)

Last week I summarized some of the recommendations for FDA in the first 67 comments to the Hatch-Waxman docket that opened in July.  Today’s entry discusses the recommendations that relate to use and distribution restrictions, citizen petitions, and what some call “product hopping.”

Continue reading “Hatch-Waxman Comments – Status Report (Part II)”

Hatch-Waxman Comments – Status Report (Part I)

What are people recommending that FDA do, to improve the current balance between drug innovation and access to generic drugs?  The docket isn’t closed yet, but I’ve read the first 67 comments. . . .

Background

FDA held a public meeting in July to consider the Hatch-Waxman Amendments, asking for comment concerning its administration of the amendments “to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”  It also opened a docket for written comments, which was originally slated to close on September 18.  On September 19, it extended the date for submission of comments to November 17.   What follows is a high level overview of some of the main recommendations for FDA in the first 67 comments.

Continue reading “Hatch-Waxman Comments – Status Report (Part I)”

Data Exclusivity for Medical Devices

Data exclusivity for drugs and biological products gets all the attention.  (In fact, recently I read a law review article asserting that medical devices are not entitled to any sort of exclusivity period after approval.  But this is wrong!)  It is apparently not as well known, but sponsors of premarket approval applications (PMAs) enjoy six years of data exclusivity.  Folks interested in FDA and innovation policy should know about the device scheme because it has a unique history (with a novel and clever – though unworkable – approach in place for seven years) and because at a high level it is still analogous to drug and biologic exclusivity even though the regulatory paradigms are different.

Continue reading “Data Exclusivity for Medical Devices”

FDA Law SSRN Reading List (August 2017)

Here’s a round up of FDA-law related readings posted to SSRN in August.

This excludes articles that were published before 2017 but posted on SSRN for the first time in August 2017.  It also omits pieces for which the abstract, but not the article, was posted.  As a result, for instance and unfortunately, it does not include Professor Jordan Paradise’s new piece, Regulatory Silence at the FDA: Impact on Drug and Biologic Competition.  The abstract indicates she explores the agency’s “reluctance” to wade into issues relating to patent law as well as the contribution of this “silence” to anti-competitive action that harms consumers.

Continue reading “FDA Law SSRN Reading List (August 2017)”

FDA’s Reliance on User Fees

Cross-posted on Notice & Comment.

On August 18, the President signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorized FDA to collect user fees in connection with new drugs, biologics, and medical devices for human use.  These user fee programs are colloquially known as PDUFA (innovator drugs and biologics), GDUFA (generic drugs), BsUFA (biosimilars), and MDUFMA (medical devices).

The White House had been urging Congress to change the structure of FDA’s user fee programs so that much of the agency’s programming is funded by user fees rather than appropriations.  Congress has more FDA user fee programs to reauthorize, however, and the Administration’s basic proposal is unlikely to go away.  I explain more of the history and the debate below.

Continue reading “FDA’s Reliance on User Fees”

ANDAs before Hatch-Waxman

Three times in the last two weeks, I have found myself explaining to someone that the Hatch-Waxman Amendments did not create the abbreviated new drug application for generic drugs.  For that matter, there were generic drugs long before 1984, and there was a generic industry long before 1984.  And that’s not even the most interesting part; at one point, FDA drafted a regulation for an ANDA pathway that would apply in the future to new NDAs and that would provide a 17-year exclusivity period.

This blog entry explains a little of the history.

Continue reading “ANDAs before Hatch-Waxman”