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 – 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 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 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 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 Cassandra A. Soltis – In an advertising challenge brought by the Perrigo Company (“Perrigo”), the National Advertising Division (“NAD”) of the Better Business Bureau recommended that Pharmavite, LLC (Pharmavite) refrain from making several claims for its Nature Made® Prenatal + DHA Liquid Softgel Vitamins …
By Kurt R. Karst – Last Friday, several days after FDA held a meeting on the public’s assessment of the overall performance of the fourth iteration of the Prescription Drug User Fee Act (“PDUFA”), which was reauthorized as Title I of the 2007 FDA …
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 …
