By Holly Fernandez Lynch Another great conference session this afternoon: “Timing Is Everything: Balancing Access and Uncertainty.” This one was moderated by Jeff Skopek, with presentations by Shannon Gibson, Trudo Lemmens, and Efthimios Parasidis. First, we heard from Gibson and Lemmens on “Overcoming ‘Premarket Syndrome,’” AKA the various problems associated with relying solely on premarket…
By W Nicholson Price II [Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging – see posts below)] The third panel at the conference covered commercial speech protection and off-label drug promotion, in reaction to the Second Circuit’s December 12 case, United States v. Caronia. Caronia was…
By Jeffrey Skopek [Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)] Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration (for now – and soon headed off to Mylan), gave a keynote address exploring the ways in which the…
By Michelle Meyer [This is off-the-cuff live blogging, so apologies for any errors, typos, etc] First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.” He prefaces his talk by noting that when he refers to…
By I. Glenn Cohen [This is off-the-cuff live blogging, so apologies for any errors, typos, etc] Panel 1: FDA in a Changing World: Lewis Grossman, Ted Ruger, Barbara Evans, moderated by Holly Fernandez Lynch Lewis Grossman, FDA in the Age of the Empowered Consumer Begins his analysis by comparing a hypothetical consumer in 1960 and…
By Holly Fernandez Lynch We’re well on our way into the Petrie-Flom Center’s Annual Conference, FDA in the 21st Century, and we’ll be live blogging the sessions today and tomorrow here at Bill of Health. Today’s sessions opened with a fantastic plenary from Peter Barton Hutt, who’s had more than five decades of experience with…
By Joanna Sax Thank you for inviting me to blog. Later this week, I’ll be attending Harvard Law School’s Petrie-Flom Annual Conference on the FDA in the 21st Century. My paper/presentation addresses the role of the FDA in the regulation of dietary supplements. By way of preview, my paper compares similarities between the dietary supplement…
Jonathan Darrow, PFC Student Fellow and HLS SJD student, will be presenting his chapter – “Pharmaceutical Efficacy: The Illusory Legal Standard” – on Tuesday, April 23, at noon in Hauser 105, Harvard Law School, Cambridge. If you’d like to review the chapter in advance, please be in touch with Jonathan directly: jon underscore darrow at…
By The Petrie-Flom Center
By Dov Fox Yesterday, I wrote about Ryan Abbott‘s new article that proposes to use health information exchanges to improve the collection of data about the safety of approved drugs. Today, I want to address his recommendation that the government pay private parties to help the Food and Drug Administration conduct post-market drug surveillance. The article argues that health information…
