By Kurt R. Karst – Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing …
By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report titled, “Medical Devices: FDA Should Expand Its Consideration of Information Security for Certain Types of Devices.” The report was intended to examine how FDA protects active implantable devices against information security risks that …
By Jeffrey K. Shapiro & Jessica A. Ritsick – ISO 13485 (2003) is an internationally recognized management system for the design and manufacture of medical devices. Most device manufacturers have quality systems intended to comply with ISO 13485. FDA has finally implemented a 2007 statutory …
By Alexander J. Varond – On September 25, 2012, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report entitled “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” PCAST is a commission of leading scientists and engineers who …
By Kurt R. Karst – Public turmoil over FDA decisions involving orphan drug exclusivity has been relatively rare in recent years. That has changed over the past several months. First there was the lawsuit brough against FDA by K-V Pharmaceutical Company to “restore” …
By JP Ellison – Traditionally, challenges to a Drug Enforcement Administration (“DEA”) immediate suspension order (“ISO”) have been litigated, in the first instance, in federal district courts. This is true even when the physician, pharmacy, distributor, wholesaler or other DEA registrant has taken a “belt and …
By Jennifer M. Thomas & Anne K. Walsh – Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a …
By Jennifer D. Newberger – On Thursday, September 20, the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”) co-sponsored a program titled “Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next?” The program discussed many aspects of the recently passed …
By Ricardo Carvajal – A federal district court dismissed a class action that took issue with a number of allegedly false and misleading claims made on the label of Benecol, a butter/margarine alternative. The claims at issue include “each serving contains .85g of plant stanol …
By Riëtte van Laack – Earlier this month, FDA announced the publication of a draft level 1 Compliance Policy Guide (“CPG”) titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” The CPG in clear …
By Kurt R. Karst – Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate). …
By Kurt R. Karst & JP Ellison – The U.S. Solicitor General filed a brief last week urging the U.S. Supreme Court not to grant a Petition for Writ of Certiorari filed earlier this year by a group of ear candle advocates after the U.S. …
By Kurt R. Karst – In our recent post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t). It’s …
By Ricardo Carvajal – A federal court has ruled that the express preemption provisions added to the Federal Food, Drug, and Cosmetic Act (“the Act”) by the Nutrition Labeling and Education Act (“NLEA”) do not preempt Florida’s standard of identity for honey. Plaintiffs in the case, …
By Riëtte van Laack – Earlier this week, the Federal Trade Commission (“FTC”) announced the settlement of a $3.7 million civil penalty case against Jason Pharmaceuticals (“Jason”), a subsidiary of Medifast Inc., for allegedly violating a 1992 FTC Order regarding weight loss claims. According to the …
