By Jennifer B. Davis – Earlier this week, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued its opinion in United States v. Endotec, Inc., an appeal from the United States District Court for the Middle District of Florida. We previously …
By Kurt R. Karst – Earlier today, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics. The 9 Warning Letters issued by FDA concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. The Warning Letters direct …
By Kurt R. Karst – Last week, the U.S. Government Accountability Office (“GAO”) issued a report, titled “Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class.” The report updates the Office’s 1995 report on the same topic (see our previous post here). The updated report was requested …
By Ricardo Carvajal – The latest Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) gives credence to a possible link between higher intake of sodium and an increased risk of hypertension. According to CDC, nearly 70% of U.S. adults …
By Susan J. Matthees – FDA announced last week that it had added the first unapproved new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (i.e., the Index) since the Agency began accepting submissions last February. The drug, …
By Jennifer B. Davis & John R. Fleder – In a March 17, 2009 opinion in United States ex rel Roop v. Hypoguard USA, Inc., the United States Court of Appeals for the Eighth Circuit held that the Relator’s qui tam allegations concerning Defendant’s alleged failure to …
By Ricardo Carvajal – In June 2008, the Technical Committee on Dietary Lipids of the International Life Sciences Institute sponsored a workshop titled “Towards Dietary Reference Intakes for Omega-3 Fatty Acids.” A summary of the workshop participants' conclusions is now published in the Journal of …
By Kurt R. Karst – In a scathing 52-page opinion issued earlier today, the United States District Court for the Eastern District of New York takes FDA to task over the Agency’s August 24, 2006 approval of a supplemental NDA (“sNDA”) for Barr Pharmaceuticals, Inc.’s …
By Kurt R. Karst – We previously reported on a complaint filed by Wyeth Holdings Corporation and its Fort Dodge Animal Health Division (collectively “Wyeth”) in the U.S. District Court for the District of Columbia against FDA and the U.S. Patent and Trademark Office (“PTO”) …
By Riëtte van Laack & J.P. Ellison – The Seventh Circuit’s March 12, 2009 decision in United States v. Farinella starkly shows what can happen when, as the court concluded, a prosecutor relies on bad facts for the government and combines that with no controlling law, …
By Ricardo Carvajal – The Augusta Chronicle reports that the Georgia legislature will soon be sending new food safety legislation to Gov. Sonny Perdue for his signature. Senate Bill 80 (S.B. 80), which was unanimously approved by both houses, directs the Commissioner of Agriculture to issue …
By Alan M. Kirschenbaum – Yesterday, we reported on the Department of Defense’s final regulation implementing section 703 of the National Defense Authorization Act for Fiscal Year 2008 (NDAA-2008). The regulation establishes a framework for manufacturers to pay refunds to the government on NDA drugs dispensed …
By Michelle L. Butler & Alan M. Kirschenbaum – On March 17, 2009, the Department of Defense (“DoD”) issued a final rule implementing section 703 of the National Defense Authorization Act for Fiscal Year 2008 (“NDAA-08”). Section 703 of the NDAA-08 provides that, for any prescriptions …
The American Intellectual Property Law Association (“AIPLA”) has appointed Hyman, Phelps & McNamara, P.C. attorney Kurt R. Karst as Chair of the organization’s Hatch-Waxman Subcommittee of the Special Committee on the FDA. “I am honored to have been nominated for this position, and look forward …
By Riëtte van Laack & Ricardo Carvajal – In a reversal of a U.S. Court of Federal Claims decision, the U.S. Court of Appeals for the Federal Circuit held in Rose Acre Farms, Inc. v. United States that an egg producer did not suffer a …
