By Jennifer M. Thomas – To the extent that Plaintiffs, or interested observers, hoped the District Court for the District of Columbia would seize an opportunity to take FDA to task for failing to prevent or stop drug shortages, they were disappointed by Judge Howell’s Thanksgiving …
By John R. Fleder – On August 8, 2013, we reported on a brief filed by the Department of Justice in United States ex rel. Ge v. Takeda Pharmaceutical Company Limited. The case involves the defendants’ alleged failure to timely report to FDA adverse drug events …
By Kurt R. Karst – Our hopes that FDA might publish a proposed rule to implement at least some of the changes made to the Hatch-Waxman Amendments to the FDC Act by the Medicare Modernization Act (“MMA”), enacted on December 8, 2003, before the 10-year anniversary …
By Kurt R. Karst – A Complaint recently filed in the U.S. District Court for the District of Delaware by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning notice of a Paragraph IV certification contained in an ANDA Par submitted to FDA for …
The Food and Drug Law Institute (“FDLI”) will hold is annual – and quite popular – Enforcement, Litigation and Compliance Conference from December 10-11, 2013 at The Westin Georgetown in Washington, DC. You can register for the conference here. A copy of the conference agenda …
By Delia A. Stubbs & John A. Gilbert – DEA didn’t waste time during its Thanksgiving break. Monday, in just shy of three weeks of the close of its comment period on its proposed rule, DEA issued a final rule placing perampanel in Schedule III. We …
By Dara Katcher Levy – We recently became aware of a lawsuit filed against FDA in the Eastern District of New York over the importation of bulk drug product. In this suit, which also names an individual FDA Compliance Officer, the importer argues that FDA’s actions …
Next Wednesday, December 12th, the ABA Section of Litigation, Products Liability Committee is sponsoring a live audio program titled “Understanding criminal prosecution of food and supplement companies (and their corporate officers) under the Food Drug and Cosmetic Act: Best practices to avoid becoming the next …
By Allyson B. Mullen & Jeffrey N. Gibbs – On November 25, 2013, CDRH issued the Final Guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” (the “RUO Guidance”) (see our previous posts on the draft …
By Kurt R. Karst – Earlier this week, Representative Robert Hurt (R-VA) introduced new legislation – H.R. 3631, the Small Manufacturer Protection Act of 2013 – that, if enacted, would bring relief to some companies that are required to pay user fees under the Generic Drug …
By Douglas B. Farquhar – Well, that certainly didn’t take long. FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find …
By Kurt R. Karst – The number of citizen petitions pending at FDA concerning Hatch-Waxman exclusivity continues to pile up. As we previously reported (here and here), FDA has already been asked on three separate occasions in 2013 to recognize 5-year New Chemical Entity (“NCE”) exclusivity …
By Ricardo Carvajal – The National Nanotechnology Initiative ("NNI") released its draft 2014 Strategic Plan for comment. The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011 (see here). As with the 2011 Plan, the draft 2014 Plan includes a …
By Kurt R. Karst – After more than three years of litigation that started with a July 2010 Complaint filed in the U.S. District Court for the Southern District of New York (see our previous post here), and that went up to the U.S. Court of …
The American Conference Institute will be holding its inaugural forum on controlled substances in Washington, D.C. from Thursday January 16 to Friday, January 17, 2014. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s John A. Gilbert will be …
