Hyman Phelps McNamara

By Kurt R. Karst –       “GADPTRA” – Now there’s an acronym you don’t see very often on this blog.  It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman …

By Karla L. Palmer & Jeffrey N. Gibbs – On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections.  The Agency states that it had taken critical look at its …

By Kurt R. Karst –       Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014.  At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding.  Most of the increase, however, is due to new …

 By Riëtte van Laack – On March 28, U.S. District Court Judge Richard Seeborg of the Northern District of California entered summary judgment for the defendants in a 2010 class-action lawsuit which had alleged that defendants misrepresented AriZona Iced Tea beverages containing “man-made” citric acid and …

 By Kurt R. Karst –        As food and drug attorneys, we rely on a certain level of FDA transparency to understand why FDA did what it did in a particular case, and to discern what that means for future Agency action (or inaction) in another …

By Ricardo Carvajal – Section 204 of the Food Safety Modernization Act ("FSMA") directed FDA to establish pilot projects “to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats …

By Etan J. Yeshua & Kurt R. Karst –       Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions.  In doing so, Judge Edward R. Korman of …

By Riëtte van Laack – Under the Organic Food Production Act (“OFPA”), the National Organic Program (“NOP”) of the USDA is authorized to establish the National List of Allowed and Prohibited Substances (“National List”).  This National List contains each synthetic substance that is permitted and each …

By Delia A. Stubbs – As previously reported, Congress recently introduced the Stop Oxy Abuse Act that would restrict the labeled indications for use of any controlled release drug containing Oxycodone-Hydrochloride (HCl) to “severe-only” versus current labeling of “moderate-to-severe” pain.  The legislation is similar to a recent …

By Kurt R. Karst –       A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the …

 By Ricardo Carvajal – When FDA published its proposed rule on preventive controls as authorized by FSMA, we noted that FDA requested comment on a number of important issues that were not addressed in the text of the regulation itself, namely product testing, environmental monitoring, and …

By Kurt R. Karst –       Despite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter.  If a company – or FDA – misses a deadline by just one day, …

By Kurt R. Karst –       A recent per curiam decision from the U.S. Court of Appeals for the District of Columbia Circuit may be the last word in litigation Hill Dermaceuticals, Inc. (“Hill”) initiated in November 2011 against FDA, as Hill filed a petition for …

By Delia A. Stubbs & Alan M. Kirschenbaum – Yesterday the OIG issued a Special Fraud Alert on physician owned distributorships, or PODs.  The OIG describes these entities as “physician owned entities that derive revenue from selling, or arranging for the sale of, implantable medical …

Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones had not yet met the internet and social media barely existed.  In the new version …