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 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 …
By Kurt R. Karst – Late yesterday, Rep. Anna Eshoo (D-CA), along with Reps. Jay Inslee (D-WA), and Joe Barton (R- TX), announced the introduction of the Pathway for Biosimilars Act (H.R. 1548). (A copy of the bill should be available soon). The introduction of …
By Kurt R. Karst – FDA has issued its highly anticipated decision concerning whether the QI Program Supplemental Funding Act of 2008 (“QI Act”) imposes a 30-month stay of approval of an ANDA referencing an old antibiotic drug product if that ANDA contains a Paragraph IV certification …
By Riëtte van Laack – In 2004, the State of California sued three tuna companies, Tri-Union Seafoods, LLC, Del Monte Corporation, and Bumble Bee Seafoods, LLC, for violation of California’s Proposition 65 because they failed to provide the required clear and reasonable warning that their …
Hyman, Phelps & McNamara, P.C. (“HP&M”) has issued a detailed analysis of the Supreme Court’s recent ruling in Wyeth v. Levine. A copy of the analysis, written by James P. Ellison and Carrie S. Martin, is available here. In Wyeth, the Court ruled that, based …
