By Kurt R. Karst – In recent weeks, two advocacy groups have sent letters to FDA requesting that the Agency enhance and accelerate its enforcement activities with respect to marketed unapproved drugs. FDA began its current Unapproved Drugs Initiative in June 2006 when the …
By Kurt R. Karst – It seems to be a popular headline these days: “FDA Sued Over [take your pick].” Following the frenetic losartan 180-day litigation – which is still not over, as FDA has filed a petition for panel rehearing and rehearing en banc …
By Susan J. Matthees – By letter of March 26, 2010, FDA denied a 2003 Citizen Petition from CTFA (now PCPC) and The Soap and Detergent Association which had requested FDA to include antiviral indications, labeling, and test methods in the Tentative Final Monograph ("TFM") …
By Jennifer B. Davis – (1) Regenerative Sciences, Inc. v. FDA. On March 26, 2010, Chief Judge Wiley Y. Daniel of the United States District Court for the District of Colorado dismissed on “ripeness” grounds a February 22, 2009 action brought by Colorado-based Regenerative Sciences, Inc. …
By Susan J. Matthees – FDA's Center for Veterinary Medicine ("CVM") recently announced an advanced notice of proposed rulemaking (“ANPRM”) to solicit comments on possible changes to the current regulation for veterinary feed directive (“VFD”) drugs. The VFD drug category was established in 1996 as part …
By Riëtte van Laack – Late last month, the U.S. Court of Appeals for the Ninth Circuit vacated a district court’s injunction against California’s prohibition of the use of non-ambulatory pigs for use in human consumption, Cal. Pen. Code § 599f. Last year, the district …
By Carrie S. Martin & Dara Katcher Levy – On March 29, 2010, FDA published a proposed rule to amend its direct-to-consumer (“DTC”) regulations to require that prescription drug advertisements present information about side effects and contraindications in a “clear, conspicuous, and neutral manner.” Current …
By Alan M. Kirschenbaum & Kurt R. Karst – On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”) (Pub. L. No. 111-148 ). A companion bill, the Health Care Education Affordability Reconciliation Act of 2010 (H.R. 4872), which …
By Kurt R. Karst & Dara Katcher Levy – Last week, FDA issued Warning Letters (here and here) to Glenmark Generics (“Glenmark”) and Konec Inc. (“Konec”) for marketed unapproved and misbranded 0.3 mg, 0.4 mg, and 0.6 mg nitroglycerin sublingual tablets. According to the letters, …
By Kurt R. Karst – Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA’s Fiscal Year 2011 budget request, which includes new user fees, …
By Kurt R. Karst – The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (“Sun”) in a Lanham Act …
By Kurt R. Karst – We’re food and drug attorneys, not patent attorneys. So, when the Federal Circuit issued its decision in Forest Group, Inc. v. Bon Tool Co. in late December 2009 concerning the false marking of spring-loaded parallelogram stilts, we didn’t pay any …
By Kurt R. Karst – Citing FDA approval standards that “may deny the benefits of medical progress to seriously ill patients who face morbidity or death from their disease,” Representative Diane Watson (D-CA) introduced H.R. 4732, the Compassionate Access Act of 2010, earlier this week. …
By David B. Clissold & Carrie S. Martin – Last Friday, FDA issued two new draft guidance documents regarding clinical trial designs: Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (February 2010) and Guidance for Industry: Non-Inferiority Clinical Trials (March 2010). These draft guidance …
By Douglas B. Farquhar – A recent of a New Jersey federal court is bound to encourage some manufacturers of an FDA-approved version of a long-marketed drug to sue competitors that continue to market unapproved versions of the same drug. Mutual Pharmaceutical Company, Inc. and …
