By Jeffrey N. Wasserstein – On October 28, 2009, Michael Loucks, the Acting U.S. Attorney for the District of Massachusetts, announced that his office has recovered over $6.8 billion in healthcare fraud cases over the last 15 years, which is almost 30% of the total healthcare …
By Alan M. Kirschenbaum & Kurt R. Karst – Earlier today, House Speaker Nancy Pelosi (D-CA) unveiled the Affordable Health Care for America Act (H.R. 3962). The bill, which is the latest version of the House’s healthcare reform proposal and the one that will go …
By Dara Katcher Levy – On October 21, 2009, First Fishery Development Services filed suit against FDA seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 – Detention Without Physical Examination of Processed Foods for Pesticides. According to the …
By Susan J. Matthees – On October 27th, on the heels of the release of the Government Accountability Office’s report in which the Office is critical of FDA’s oversight of clinical investigators (see our previous post), Rep. Joe Barton (R-TX) introduced H.R.3932, the Strengthening of …
By JP Ellison – Last year we posed the question “Are the Stars Lining Up for FDA Civil Penalties?” The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. (“TMJI”) and its founder …
By Susan J. Matthees – Last month the Government Accountability Office ("GAO") published a new report ("GAO report") on the oversight of clinical investigators. The report is critical of FDA’s oversight of clinical investigators, citing numerous instances where FDA did not take timely action to respond …
By Kurt R. Karst – The Medicines Company is reportedly continuing its multi-year and multi-million dollar lobbying effort to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved on December …
By Ricardo Carvajal – The Smart Choices ProgramTM has announced “that it will voluntarily postpone active operations and not encourage wider use of the logo at this time by either new or currently enrolled companies.” The announcement cites FDA’s recent letter to industry announcing the …
By Larry K. Houck – In an effort to combat a new aspect of the methamphetamine epidemic, Congress has introduced yet amendment to the Controlled Substances Act (“CSA”). Representative John Boozman (R-AR) has introduced legislation in the House that would enhance criminal penalties for methamphetamine …
By Larry K. Houck – In a departure from US DOJ policy, Attorney General Eric Holder announced formal federal guidelines for U.S. Attorneys in states that have authorized marijuana for medical use. The guidelines, set out in an October 19, 2009 memorandum authored by Deputy Attorney …
By Ricardo Carvajal – FDA has issued a letter to industry stating that the agency intends to take enforcement action against front-of-package ("FOP") or shelf labeling that provides false or misleading information (including implied nutrient claims that don't comply with regulatory requirements). Further, the letter states …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the Central District of California a filed by Mutual Pharmaceutical Company, Inc. (“Mutual”), and AR Scientific, Inc. and AR Holding Company, Inc. (“AR”) in a Lanham Act case concerning the continued marketing …
By Ricardo Carvajal – The Chief Administrative Law Judge (“ALJ”) at the Federal Trade Commission (“FTC”) has issued a decision that, if upheld by the Commissioners of the FTC, would dismiss an FTC complaint which alleged that a marketer of dietary supplements “disseminated” or “caused …
By Kurt R. Karst – Consistent with recent wins concerning generic PROGRAF (tacrolimus) and generic ZOSYN (piperacillin sodium; tazobactam sodium) Injection (here and here), the U.S. District Court for the Central District of California recently ruled that FDA’s April 2008 denial of a citizen petition and decision …
By Ricardo Carvajal – In an unusual step, FDA and FTC have issued a joint warning letter to the internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. According to the letter, the product “has not been …
