By Kurt R. Karst – Last week, the Natural Resources Defense Council (“NRDC”) filed a Complaint in the U.S. District Court for the Southern District of New York against FDA in an effort to force the Agency to finalize its topical antimicrobial drug products Over-the-Counter …
By Kurt R. Karst – In a Federal Register notice scheduled for publication on August 4th, FDA will announce the Prescription Drug User Fee Act (“PDUFA”) user fee rates for Fiscal Year (“FY”) 2011. As in all previous years under the fourth iteration of PDUFA, …
By Kurt R. Karst – On July 26, 2010, the U.S. District Court for the District of Wyoming denied a Motion for Temporary Restraining Order and Preliminary Injunction filed last week by Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) against FDA in …
By Kurt R. Karst – Earlier this week, Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Wyoming requesting that the court enjoin FDA …
By Nisha P. Shah – A U.S. District Court recently held that misrepresentation and false description of active ingredients by a manufacturer of generic prescription vitamins can be actionable under the Lanham Act. Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, LLC. Plaintiff, Sciele Pharma, Inc., develops …
By William T. Koustas – FDA recently released a draft of it class-wide opioid REMS in preparation for an advisory committee meeting on the issue. The Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory …
By Alexander J. Varond* & Kurt R. Karst – Recently, the U.S. District Court for the District of Columbia dismissed a case brought by the Coalition for Mercury-Free Drugs (“Coalition”). Judge Reggie B. Walton ruled that the Coalition lacked standing to ask the court to ban …
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 …
