By Kurt R. Karst & Jeffrey K. Shapiro – French company PREVOR has filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that PREVOR’s Diphoterine® Skin Wash (“DSW”) is a drug-device combination product with a “drug” primary mode of …
About 18 months after coming to FDA to serve as Chief Counsel, Ralph Tyler will be leaving the Agency, according to an FDA-wide e-mail sent out on June 30th by FDA Commissioner Margaret Hamburg. Prior to joining FDA, Mr. Tyler served as Insurance Commissioner of …
By Kurt R. Karst – A recent unpublished decision out of the U.S. District Court for the District of New Jersey presented an interesting public disclosure issue that we think will be of interest to the Hatch-Waxman community. The case, like so many Hatch-Waxman cases, is …
By Kurt R. Karst – The continuing court battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) could be derailed if a recent amendment added to the House version of the America Invents …
By Dara Katcher Levy – Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most …
By Ricardo Carvajal – The New England Journal of Medicine published two articles bound to stoke more controversy in the battle over approaches to countering obesity. A perspective piece authored by Dr. Kelly Brownell, Director of the Yale Rudd Center for Food Policy and Obesity, and …
By Ben Wolf* and Jeff Wasserstein – Justice Kennedy delivered the opinion of the Supreme Court in today’s 6-3 decision in Sorrell v. IMS Healthcare Inc. (Docket No. 10-779). This decision strikes down a Vermont law prohibiting the sale, disclosure, and use of pharmacy records that reveal …
By Kurt R. Karst – Like a young attorney (full of angst) waiting for Bar Exam results to be posted on the Internet, we sat in front of our computer this morning constantly hitting the “refresh” button to update the U.S. Supreme Court’s “2010 Term Opinions …
By Dara Katcher Levy – Earlier this week, FDA announced the release of a report regarding the increasing globalization of FDA-regulated products that are consumed by Americans, and how FDA intends to improve the safety and quality of these products. FDA states that the report was prompted …
By Riëtte van Laack – Although there are currently no federal standards governing the labeling of organic cosmetics, cosmetic products sold in California are subject to the California Organic Products Act of 2003 (“COPA”). Under this law, cosmetics labeled or represented as "organic" must contain at …
By Ricardo Carvajal – In October 2008, the Natural Resources Defense Council ("NRDC") submitted a citizen petition to FDA asking the agency to repeal regulations that permit food additive uses of BPA, to which FDA tentatively responded with a standard letter stating that “limited availability of …
By Kurt R. Karst – Although many have tried (see, e.g., here), in our experience, few have succeeded in convincing a court to decide to grant a motion to extend a 30-month stay on FDA’s approval of a generic drug application. (The most recent case we …
By John R. Fleder – For over forty years there has been a unit in the Department of Justice dedicated to representing FDA in court actions. Originally housed in the Antitrust Division under the name “Consumer Affairs Section”, the office was moved to DOJ’s Civil Division …
By Ricardo Carvajal & Riëtte van Laack – When the FDA Nanotechnology Task Force issued its report in 2007, it declined to adopt precise definitions of the terms "nanoscale materials" or "nanotechnology," opting instead to take an inclusive approach. FDA has now issued draft guidance on nanotechnology …
By Susan J. Matthees – On Tuesday, sunscreen finally stepped out of the shadows at FDA. After years waiting, FDA announced the availability of a number of new documents related to over-the-counter (“OTC”) sunscreen drug products marketed in the US, including a guidance document on enforcement …
