By Nicolas Terry and Frank Pasquale This week we welcome Melinda J. Beeuwkes Buntin, Chair of the Department of Health Policy at Vanderbilt University’s School of Medicine. She previously served as Deputy Assistant Director for Health at the Congressional Budget Office (CBO), and worked at the Office of the National Coordinator for Health IT. At RAND, Melinda served as…
By Rachel Sachs This morning, the FDA finally reached a decision in the closely watched case of Sarepta Therapeutics and its drug for the treatment of Duchenne Muscular Dystrophy (DMD). The FDA granted accelerated approval to Sarepta’s drug, Exondys, on the condition that Sarepta complete a new trial demonstrating the drug’s clinical effectiveness. As regular…
September 12, 2016 5-7 PM Hauser Hall, Room 104 Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA Download the Presentation: Pharmaceutical Federalism Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration.…
By Rachel Sachs For weeks now, the list price of Mylan’s EpiPen ($600 for a two-pack) has been exhaustively covered by journalists, debated by academics, and skewered by policymakers as an example of the pricing excesses of even generic pharmaceutical companies. Mylan’s latest response to the outrage? Announce that soon, it will be launching a…
By Nicholson Price Drug prices have been making waves in the news recently. The most recent case is the huge price hikes of the EpiPen, which provides potentially life-saving automatic epinephrine injections to those with severe allergies. Mylan, which makes the EpiPen, has raised its price some 450% over the last several years. The EpiPen…
By Ameet Sarpatwari and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy. Below are the papers identified from the month of July. The selections feature topics ranging from the reporting of clinical trial subgroup effects in top…
By Chris Robertson July has been a busy month for those following the controversy around off-label promotion of drugs and devices. As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.…
By Ameet Sarpatwari and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy. Below are the papers identified from the month of June. The selections feature topics ranging from lessons from the history of randomized controlled trials, to…
The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years…
By Rachel Sachs Earlier today, the NIH rejected a request filed by consumer groups including Knowledge Ecology International (KEI) to exercise the government’s march-in rights on an expensive prostate cancer drug, Xtandi. Xtandi costs upwards of $129,000 per year, and KEI had asked the government to exercise its rights under the Bayh-Dole Act, which specifies…
