By Kurt R. Karst – Late last Friday, in a case that is full of twists and turns, the U.S. District Court for the Eastern District of Virginia (Alexandria Division) added another twist (or turn) and ordered the U.S. Patent and Trademark Office (“PTO”) to …
By Alan M. Kirschenbaum – The Obama Administration took two steps on Friday to advance the implementation of health care reform, both of which are of interest to drug manufacturers. First, CMS issued a draft agreement and final guidance on the Part D coverage gap …
By Kurt R. Karst – Last fall, we reported on a decision from Judge Richard E. L. Strauss of the Superior Court of California, County of San Diego, in which he granted motions for summary judgment ruling that Bayer AG and several generic drug …
By Ricardo Carvajal – FDA’s approach to regulation of nanotechnology has remained essentially unchanged since the issuance of the agency’s Nanotechnology Task Force Report in 2007. In that report, which was endorsed by then-Commissioner von Eschenbach, FDA declined to adopt a formal definition of nanotechnology, …
By Kurt R. Karst – Late on May 17th, the U.S. Court of Appeals for the District of Columbia Circuit denied, in separate orders (here and here), FDA’s petition for panel rehearing and rehearing en banc of the D.C. Circuit’s March 2, 2010 decision in Teva …
By Kurt R. Karst – FDA’s recent issuance of its annual “Dear Colleague” letter, sent in anticipation of the Fiscal Year 2011 Prescription Drug User Fee Act (“PDUFA”) user fee invoices for product and establishment fees, is a good reminder for companies to review …
By Kurt R. Karst – FDA’s recent decision to approve Sandoz Inc.’s (“Sandoz’s”) ANDA No. 40-445 for a generic version of King Pharmaceuticals, Inc.’s (“King’s”) SKELAXIN (metaxalone) Tablets, 800 mg, with a period of 180-day exclusivity is one of the few cases in which …
By Wes Siegner – FDA recently posted a compliance program for dietary supplements that provides useful insights on where the agency is likely to focus its enforcement resources in the coming year. Illustrating FDA’s institutional biases, the agency prioritizes inspections to focus more on "non-traditional" …
By Susan J. Matthees & Alan M. Kirschenbaum – The state and federal regulatory and legislative focus on drug marketing shows no signs of abating. Yesterday, we reported on FDA’s “Bad Ad” initiative to get health care practitioners to report to FDA violative drug promotion …
By Kurt R. Karst – The growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”) has been a thorn in the side of the generic drug industry for quite some time now. As we previously reported, the …
By Dara Katcher Levy – On May 11, FDA announced the launch of the “Bad Ad Program,” an effort to educate Health Care Professionals on misleading prescription drug promotion and provide them with an easy way to report it (just dial 877-RX-DDMAC). The program, which …
By Ricardo Carvajal & Wes Siegner – FDA recently posted what appears to be the first warning letter to a firm for violations of the dietary supplement good manufacturing practice ("GMP") regulations in 21 CFR Part 111. The warning letter marks a point of transition …
By Kurt R. Karst – On May 10, 2010, a 3-judge panel of the U.S. Court of Appeals for the Federal Circuit (Circuit Judges Newman, Rader, and Linn) issued its unanimous decisions in two cases that should solidify as to when a patent covering …
By Riëtte van Laack – In 2005, the Sanitary Food Transportation Act of 2005 (“SFTA”) was enacted. This law shifted responsibility for safe transportation of food from the U.S. Department of Transportation to FDA. Among other things, the SFTA amended the FDCA to include section …
By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance websites”), which included disease-state information and clinical data about gastrointestinal stromal tumors (“GIST”) and chronic …
