By Kurt R. Karst – Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia ruled in a 27-page opinion issued last Friday that the 180-day exclusivity forfeiture patent information withdrawal provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) is not ambiguous and …
By Kurt R. Karst – Last Friday, the House Energy and Commerce Committee favorably reported its version of “America’s Affordable Health Choices Act” (H.R. 3200) by a 31-28 vote after adopting several amendments. A copy of the bill and amendments are available here. Importantly, the …
By Carrie S. Martin – Last Wednesday, the Senate Special Committee on Aging held a hearing to discuss the conflicts of interest presented by the funding of continuing medical education (“CME”) by pharmaceutical and medical device companies. Lewis Morris, Chief Counsel to the Office of …
Yesterday, President Obama announced that he intends to nominate Anne Northrup as a Commissioner of the Consumer Product Safety Commission. Anne Northrup was a Congresswoman from Kentucky from 1997-2006. As we previously reported, earlier this month, Inez Moore Tenenbaum was sworn in as the ninth …
By Ricardo Carvajal – The U.S. House of Representatives has passed the Food Safety Enhancement Act of 2009, which would substantially strengthen FDA’s regulatory authority over foods. The bill would grant FDA mandatory recall authority, expanded access to records, stronger seizure and administrative detention authorities, …
By William T. Koustas – Today, the FTC announced that it is delaying enforcement of the controversial Red Flags Rule (“the Rule”) until November 1, 2009. The FTC press release states that it is extending the August 1, 2009 deadline, previously discussed in this blog, …
By Cassandra A. Soltis – In Pom Wonderful LLC v. Ocean Spray Cranberries, Inc., 2009 WL 2151355 (C.D. Cal. 2009), the U.S. District Court for the Central District of California determined that Pom Wonderful LLC’s (Pom’s) false advertising claim against Ocean Spray Cranberries, Inc. (Ocean …
By Kurt R. Karst – On July 28, 2009, FDA will publish a final rule amending the Agency’s regulations requiring that NDA holders submit in annual reports certain information to the Agency concerning authorized generics. The regulations, which were first proposed in September 2008 – …
By Ricardo Carvajal – On July 23, FDA held the first of three public workshops to explain the Reportable Food Registry requirements that will take effect on September 8, 2009. One thing was made clear: the agency has no plans to offer a definition of …
By Carmelina G. Allis – We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code. The defendants allegedly conducted clinical …
Hyman, Phelps & McNamara’s John R. Fleder has written an article in the July/August 2009 edition of the Food and Drug Law Institute’s Update Magazine. The article is entitled: “Vindicated on Appeal – It Does Happen.” The article discusses a recent ruling in United States …
By William T. Koustas – Last week, FDA announced the approval of Onsolis (fentanyl buccal soluble film) with a substantial Risk Evaluation and Mitigation Strategy ("REMS"), as well as a boxed warning. Onsolis is a potent opioid that is administered through the mucous membranes of …
By John A. Gilbert & Larry K. Houck – The Senate recently passed S. 256 which places additional requirements on retailers that sell ephedrine and pseudoephedrine. The bill, known as the “Combat Methamphetamine Enhancement Act of 2009,” was referred to the House (H.R. 2923), which …
By Ricardo Carvajal – The Institute of Food Technologists (“IFT”) has published an expert report that addresses the challenge of responding to food contamination events in the face of limited scientific information. The report describes the U.S. legal framework that governs substances intentionally or inadvertently …
By Ricardo Carvajal – The Council to Improve Foodborne Outbreak Response (“CIFOR”) has published guidelines intended to help local, state and federal agencies improve their response to foodborne disease outbreaks. The guidelines address planning and preparation, surveillance and outbreak detection, investigation of clusters and outbreaks, …
