By William T. Koustas – As we have previously reported (here, here, and here), the FTC has delayed enforcement of its Red Flags Rule (“the Rule”) several times since its original effective date of November 1, 2008. Now, some in Congress have requested that the …
By Ricardo Carvajal – Senators Harkin and Hatch have introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010 (S. 3414). The statement of findings notes that FDA has been slow to implement the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, and …
By Kurt R. Karst – Earlier this week, we reported on the latest in the ongoing saga 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) – an order from the U.S. …
By Ricardo Carvajal – FDA has revised its draft guidance on the Reportable Food Registry (“RFR”) to address the new electronic portal for submission of reports, and in response to recent questions that the agency received from industry. Among the more significant changes and additions: A …
By John R. Fleder & Ricardo Carvajal – The Federal Trade Commission ("FTC") has announced a second opportunity for public comment on its proposed issuance of compulsory process orders to 48 food and beverage firms. If those orders are issued, the FTC will demand information …
By Kurt R. Karst – In a somewhat unusual move, the U.S. Supreme Court has asked the U.S. Department of Justice (Solicitor General of the United States) to weigh in on generic drug preemption. The move signals that the Court has continued interest in this …
By Ricardo Carvajal – FDA announced that Reportable Food Registry ("RFR") reports can now be submitted through the new FDA-NIH Safety Reporting Portal, which will also accept reports about problems with pet food, animal drug adverse event reports, and human gene transfer clinical trial adverse …
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" …
