By Peter M. Jaensch - In the latest installment in the criminal prosecution of Lauren Stevens, an attorney formerly employed by GlaxoSmithKline ("GSK"), the U.S. Department of Justice announced on April 14, 2011, that a grand jury in the U.S. District Court for the District of …
By Kurt R. Karst – Since the U.S. Court of Appeals for the Federal Circuit issued its December 2009 decision in Forest Group, Inc. v. Bon Tool Co. concerning the maximum $500 per violation penalty for intentionally falsely marking a product (in that case, spring-loaded parallelogram …
By Kurt R. Karst – FDA has responded to requests included in two reports accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (Public Law No. 111-80) – House Report No. 111-279 and Senate Report 111-39 – requesting information …
By Dara Katcher Levy – FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) has announced that it will be holding a series of Enforcement Webinars that will provide an opportunity for attendees to ask DDMAC questions about the Warning and Untitled Letters it issues each …
By Kurt R. Karst – On occasion we dream about Hatch-Waxman and wake up in the morning with a burning question. One of the recent questions we wondered about is whether FDA would take the position that an ANDA sponsor who amends a long-pending ANDA to …
By Cassandra A. Soltis – In an opinion dated April 6, 2011, Judge Beryl Howell of the U.S. District Court for the District of Columbia granted summary judgment for the FDA in a case challenging the dietary supplement good manufacturing practice (“GMP”) regulations. Alliance for Natural …
Hyman, Phelps & McNamara's Ricardo Carvajal will be speaking on the Reportable Food Registry at the American Conference Institute’s 2nd Advanced Summit on Food Safety Regulatory Compliance, taking place in Chicago from June 15-16, 2011. See here for a copy of the brochure and to register …
By Ricardo Carvajal – FDA has a web page devoted to the Food Safety Modernization Act (“FSMA”) that provides ready access to useful information on the new law and on FDA’s implementation activities, including: the text of the law; Q&A’s; descriptions of the work groups charged with implementation; the text …
By Roger C. Thies – On March 30, 2011, FDA publicly announced that it would not take enforcement action under certain conditions against pharmacies that compound hydroxyprogesterone caproate for injection for the reduction of the risk of certain preterm births in women who have had at …
By Carmelina G. Allis – A March 24, 2011 warning letter from FDA cites a rarely invoked provision in the Investigational Device Exemption (“IDE”) regulations. It is not clear whether this warning letter is an outlier or a harbinger of more aggressive inspections by the Division …
By Ricardo Carvajal – Rep. Henry Waxman, Ranking Member of the Committee on Energy and Commerce, sent FDA Commissioner Margaret Hamburg a letter urging the agency to investigate Kretek International’s (Kretek) marketing of clove-flavored cigars, and to ban flavored cigars that are “marketed for the purpose …
By Kurt R. Karst – Some court decisions just leave us scratching our heads after we read them, and the decision handed down last week by Judge Freda Wolfson of the U.S. District Court for the District of New Jersey in Medeva Pharma Suisse A.G. v. …
By John A. Gilbert & Peter M. Jaensch – Following what appears to have been the stall of the Arkansas prescription-only Pseudoephedrine bill (House Bill 1444) in mid-March, on March 23, 2011, Arkansas enacted a new law in the effort to combat illicit methamphetamine production. …
By Kurt R. Karst – Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a pair of decisions in a long-running dispute between Lannett Company, Inc. (“Lannett”), the self-proclaimed “oldest generic drug manufacturer” in the United States (founded in 1942), and Celgene …
By Roger C. Thies – FDA announced on March 30, 2011 that it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or …
