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 …
By Jeffrey K. Shapiro – On May 3, FDA announced that it has ordered Baxter to recall and destroy an estimated 200,000 Colleague infusion pumps in use, reimburse customers for the “value” of the recalled device, and assist in finding a replacement. The press release …
By Peter M. Jaensch – On Friday, April 30th, 2010, the U.S. Sentencing Commission sent Congress amendments to the federal Sentencing Guidelines applicable to organizations such as corporations. On January 21, 2010, we reported on proposed changes to the federal Sentencing Guidelines. The changes would have apparently …
By Kurt R. Karst – Last week’s decision by a 3-judge panel of the U.S. Court of Appeals for the Second Circuit in In re: Ciprofloxacin Hydrochloride Antitrust Litigation affirming a 2005 decision by the U.S. District Court for the Eastern District of New York …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the Federal Circuit ruled 3-0 to affirm a March 2009 decision from the U.S. District Court for the District of Columbia granting summary judgment to FDA and the U.S. Patent and Trademark …
By Alan M. Kirschenbaum – Five weeks after the enactment of health care reform, CMS has, with surprising alacrity, issued a draft guidance on one of the provisions of the legislation that will be most costly to brand drug manufacturers – the Medicare Part D …
By Ricardo Carvajal – Some smaller cigarette manufacturers have sued FDA to invalidate a provision in FDA’s recently issued final rule that would restrict a manufacturer from using certain product names on the ground that the restriction violates the First and Fifth Amendments, among other …
