By William T. Koustas – Regenerative Sciences, Inc. (“Regenerative”) filed a complaint in the U.S. District Court for the District of Columbia against FDA on June 22nd in order to prevent FDA from essentially closing the business. Regenerative owns a procedure by which physicians take bone …
By Carrie S. Martin – The Office of Inspector General (“OIG”) recently issued a report detailing the inclusion of foreign clinical trial data in New Drug Applications (“NDAs”) and Biologics License Applications (“BLAs”) and FDA’s oversight of foreign clinical trial sites. The OIG examined all …
By Kurt R. Karst – Earlier this week, FDA announced Pfizer’s voluntarily withdrawal (at least insofar as a voluntary withdrawal is truly voluntary when FDA requests it) of MYLOTARG (gemtuzumab ozogamicin for Injection) from the market after a required postmarketing study failed to demonstrate clinical …
By Kurt R. Karst – Earlier today, the U.S. Supreme Court declined to hear appeals in two separate cases of interest to the food and drug law bar involving the False Claims Act (“FCA”) – Hopper v. Solvay Pharms, Inc., 588 F.3d 1318 (11th …
By Jeffrey N. Wasserstein – Loyal readers of the FDA Law Blog have followed (with bated breath) the saga of Vermont’s law that prohibits pharmaceutical and medical device companies from giving many items that are permitted under the PhRMA Code and AdvaMed Code. The plot …
By Susan J. Matthees – FDA has denied a Citizen Petition requesting that FDA require drug and device companies to submit data only from non-animal test methods ("NATMs") whenever NATMs are available. The Citizen Petition was submitted on behalf of the Mandatory Alternatives Petition Coalition …
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 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 …
