By Kurt R. Karst – Responding to a request from certain Members of Congress, the U.S. Government Accountability Office (“GAO”) has released a report evaluating FDA’s use of evidence from non-inferiority trials to establish a drug’s effectiveness and support approval of new therapies. As …
By Kurt R. Karst – On August 16, 2010, FDA announced that the Agency plans to follow through on previous correspondence threatening to withdraw approval of all marketing applications for the Subpart H (accelerated approval) drug Midodrine HCl. FDA also issued a Notice of …
By Kurt R. Karst – The 60 Plus Association, a senior advocacy group and alternative to AARP, has joined the debate over marketed unapproved drugs, asking FDA to step-up enforcement action and starting its “Keep Seniors Safe” initiative, which “advocates the removal of unapproved …
By William T. Koustas – We have previously written that Regenerative Sciences (“Regenerative”), a Colorado-based stem cell company, filed a complaint in the U.S. District Court for the District of Columbia against FDA in order to enjoin it from regulating Regenerative’s use of cultured stem …
By Kurt R. Karst – Yesterday, Senator Sam Brownback (R-KS) (along with Sen. Sherrod Brown (D-OH)) introduced S. 3697, the Creating Hope Act of 2010. The bill would amend FDC Act § 524 to change the transferable Priority Review Voucher (“PRV”) program created by …
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 …
