By Jonathan J. Darrow Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness. Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not…
By The Petrie-Flom Center Please save the date for this upcoming conference at Harvard Law School on May 17, 2013: Issues and Case Studies in Clinical Trial Data Sharing: What Have We Learned? Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at…
By Michelle Meyer So, one thing they say about being on the law teaching market is that you likely will never before have enjoyed — and, less happily, will likely never again enjoy — so much attention to your work and so many opportunities to discuss it. That’s totally true, and it’s totally fabulous. But there’s…
By Casey Thomson The flu, gun control, and legal action against the FDA – all amongst our Twitter feeds this past week. Read on for more: Frank Pasquale (@FrankPasquale) retweeted a link to the FDA’s current legal trouble concerning their failure to disclose antibiotic resistance data. The Government Accountability Project (GAP) is accusing…
By Holly Fernandez Lynch I don’t even want to imagine the creative titles law students might come up with for a note on this topic, but it is a question worth asking/answering: how should the FDA regulate fecal transplants? Check out the NY Times article on the treatment here – apparently, it works!
By Patrick O’Leary Last spring I had the chance to work as a research assistant for Marc Rodwin, a Lab Fellow at Harvard’s Edmond J. Safra Center for Ethics, reading through hundreds (perhaps thousands) of pages of Congressional hearing transcripts from the 1960s and 1970s relating to the federal regulation of drugs. In reading the…
Food & Drug Law: Past, Present & Future Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS Thursday, January 17, 2013 Wasserstein 2019; Milstein West AB Harvard Law School 4:00pm (reception to follow) Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for…
By Jonathan J. Darrow In a well-researched, recent post, Patrick O’Leary addresses the FDA’s efficacy requirements as applied to an old drug, Acthar (corticotropin), that was first approved in 1952 and granted an orphan designation in 2010 for the treatment of infantile spasms. The initial approval therefore occurred before the Drug Amendments of 1962, which…
By Patrick O’Leary While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it…
SAVE THE DATE! Food & Drug Law: Past, Present & Future Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS Thursday, January 17, 2013 Wasserstein 2019; Milstein West AB Harvard Law School 4:00pm (reception to follow at 5:30) Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in…
