By Ricardo Carvajal – Capping a week-long flurry of legislative activity, the Senate reportedly passed the Food Safety Modernization Act by a voice vote Sunday night. The legislation now returns to the House, where approval is likely. Given that the President’s signature is certain, it now appears …
By Riëtte van Laack – On December 15, 2010, FDA took several steps to increase its enforcement against products that are marketed as dietary supplements but contain analogs of, or the same active ingredients as, FDA-approved drugs, or other substances that do not qualify as dietary …
By Ricardo Carvajal – The massive spending bill to which food safety legislation was attached (and that also includes provisions on rare and neglected diseases) – the Fiscal Year 2011 Omnibus Appropriations Act – has been pronounced dead. Although Congress may yet find another vehicle for …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting "Food Safety: Unintended Components/Contaminants of Food" at the Food and Drug Law Institute's ("FDLI’s") January 24-25, 2011 conference, "Introduction to Food Law and Regulation: How the Government Regulates the Food Industry," which is part of FDLI’s Food Week …
By Ricardo Carvajal – FTC announced a proposed settlement with Dannon over the latter’s allegedly deceptive advertising claims for two of its probiotic products, Activia and DanActive. FTC’s complaint alleged that Dannon explicitly or implicitly represented that one serving of Activia relieved temporary irregularity and helped …
By Ricardo Carvajal – A class action lawsuit has been filed in California alleging that the McDonald’s Corporation engages “in the unfair, unlawful, deceptive and fraudulent practice of promoting and advertising McDonald’s Happy Meal products to very young California children, using the inducement of various toys.” The …
Hyman Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare annual summaries of antimicrobials sold or distributed for use in food-producing animals. The data are derived from information sponsors of new animal drug applications provide to FDA (as …
By Kurt R. Karst – Earlier this week, Senate Appropriations Committee Chair Senator Daniel Inouye (D-HI), released the text of the proposed Fiscal Year 2011 Omnibus Appropriations Act. The almost 2,000-page bill, if enacted, would fund the government until September 30, 2011. In addition to an …
By Kurt R. Karst – When we last left you in the battle over FDA’s approval of a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection), Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia denied …
By Kurt R. Karst – Last Friday, Teva Pharmaceuticals USA, Inc. (“Teva”) filed its opposition brief to Apotex, Inc.’s (“Apotex’s”) Petition for Writ of Certiorari, which Apotex filed with the U.S. Supreme Court in October asking for a review of the U.S. Court of Appeals for …
By Riëtte van Laack – FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease. In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship …
June Stephenson, a 37-year employee in FDA’s Office of Chief Counsel, will retire on December 31, 2010. Ms. Stephenson has been the principal secretary for every chief counsel at FDA since 1974. At a December 8th retirement party, her contributions were recognized by almost all …
By Susan J. Matthees – Last Tuesday, FDA announced the availability of final results from its experimental study of graphic cigarette warning labels. As we previously reported, FDA proposed 36 graphic warning images to accompany the health warning statement required under section 201 of the Family …
By Kurt R. Karst – Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501). As we previously reported, the petitions presented almost identical questions for the …
