By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA officials, at a July 19-20, 2010 workshop, stated that the agency intends to end the “exercise enforcement” authority over some laboratory-developed tests (“LDTs”). Put more plainly, FDA now plans to regulate some LDTs as medical …
By Kurt R. Karst – As we thought might happen, Sanofi-aventis U.S. L.L.C. (“Sanofi”) sued FDA over the Agency’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection). (On the …
By Ricardo Carvajal – As we discussed in a prior posting, Section 4205 of the Patient Protection and Affordable Care Act requires the display of certain nutrition information by chain restaurants and retail food establishments with 20 or more locations doing business under the same …
By Kurt R. Karst – On July 26, 2010, the U.S. District Court for the District of Wyoming denied a Motion for Temporary Restraining Order and Preliminary Injunction filed last week by Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) against FDA in …
By Kurt R. Karst – Earlier today, FDA issued its long-awaited response (45 pages) to a February 2003 citizen petition submitted to the Agency on behalf of Aventis Pharmaceuticals, Inc. (“Aventis”) concerning the approval of generic versions of the company’s anti-coagulant drug LOVENOX (enoxaparin sodium …
By Kurt R. Karst – Earlier this week, Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Wyoming requesting that the court enjoin FDA …
By Nisha P. Shah – A U.S. District Court recently held that misrepresentation and false description of active ingredients by a manufacturer of generic prescription vitamins can be actionable under the Lanham Act. Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, LLC. Plaintiff, Sciele Pharma, Inc., develops …
By Kurt R. Karst – Earlier this week, Rep. Jan Schakowsky (D-IL), along with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced H.R. 5786, the Safe Cosmetics Act of 2010. The bill would significantly change the regulatory structure of cosmetics in the U.S., …
By Susan J. Matthees – FDA recently announced that the Agency is seeking public comments on how to implement section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose nutrition information. The docket opened on …
By Kurt R. Karst – Last week, the U.S. Court of Appeals for the Federal Circuit denied Lupin Pharmaceuticals, Inc.’s (“Lupin’s”) Petition for Rehearing en banc of a May 10, 2010 panel decision in Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. in which the Court affirmed …
By Kurt R. Karst – As the U.S. Senate Committee on Appropriations begins its markup and consideration of appropriations bills for Fiscal Year (“FY”) 2011, and in particular the Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill (S. 3606), rare and neglected disease …
In the May/June 2010 edition of FDLI Update, HP&M Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves.” The article addresses various issues that companies face when they are confronted with employees who …
By Peter M. Jaensch – On July 14, 2010, the Federal Trade Commission (“FTC”) announced an agreement with Nestle HealthCare Nutrition, Inc. (“Nestle”) to settle an FTC investigation with regard to alleged false and misleading health claims. The FTC's Complaint arose from claims made by …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Diane B. McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises …
On July 14th, the FTC announced the settlement of a significant false advertising case against Iovate Health Sciences U.S.A. and Canadian affiliates for false weight loss, cold, flu and allergy claims relating to 5 of the company's products. The settlement includes $5.5M for refunds to …
