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