By Riëtte van Laack – The United States Department of Agriculture (“USDA”) finalized its rulemaking concerning Country of Origin Labeling (“COOL”) mandated by the 2002 and 2008 Farm Bills. The final rule requires that retailers notify customers of the country of origin of covered commodities (meat …
By Ricardo Carvajal – Several federal agencies, including FDA, have jointly issued a draft guidance for comment purposes only that recommends a wide range of practices intended to help ensure that imported products comply with applicable federal laws. The action was taken pursuant to a …
By Alan M. Kirschenbaum – Today’s Federal Register announces FDA’s issuance of a final “Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical …
By Ricardo Carvajal – The Supreme Court has denied certiorari in the case of Albertson’s, Inc. v. Kanter (No. 07-1327). As we previously reported, the California Supreme Court ruled against federal preemption of plaintiffs’ lawsuit alleging false advertising and unfair and deceptive trade practices in …
By Ricardo Carvajal & Colleen M. Brown – Purified water is at the heart of a recently decided case in which the Federal Food, Drug, and Cosmetic Act ("FDC Act") was found to expressly preempt state law claims alleging unfair and deceptive trade practices in violation …
By John A. Gilbert & Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a final rule on December 29, 2008 setting annual self-certification fees at $21 for “regulated sellers.” “Regulated sellers,” persons and entities who sell scheduled listed chemical products at retail locations, …
By Ricardo Carvajal – On December 10, 2008, FDA issued a warning letter contending that the Coca-Cola Company’s Diet Coke Plus product violates FDC Act section 403(r)(1)(A) because it fails to comply with regulations that govern the use of the nutrient content claim “plus.” Nutrient …
By Ricardo Carvajal – FDA has announced the availability of a guidance for industry titled “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.” Under certain conditions, section 403(r)(6) permits manufacturers of dietary supplements to make nutritional …
By Kurt R. Karst – FDA’s recent approval of Antisoma Research Limited’s orphan drug, oral fludarabine phosphate, with 7 years of orphan drug exclusivity for the treatment of certain adult patients with B-cell chronic lymphocytic leukemia got us thinking about the unusual case of the …
By Ricardo Carvajal – FDA has issued a final rule that requires declaration of the color additives cochineal extract and carmine in the ingredient statement on the label of all food and cosmetic products that contain those additives. FDA has made no changes to the …
By Kurt R. Karst – We previously reported on the Patent and Trademark Office’s (“PTO’s”) determination that U.S. Patent #5,817,338 (“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New …
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at two upcoming conferences on various Hatch-Waxman Act product lifecycle management issues. The first conference is the Center for Business Intelligence’s Premier Bio/Pharmaceutical Summit on Legal & Regulatory …
By Jeffrey N. Wasserstein, Michelle L. Butler, and Jamie K. Wolszon – On December 18, 2008, the Advanced Medical Technology Association (“AdvaMed”) announced the release of a newly revised version of the “Code on Ethics on Interactions with Healthcare Professionals,” which is a voluntary code focusing …
By Kurt R. Karst – Last week, ViroPharma Inc. announced that the company filed a complaint in the U.S. District Court for the District of Columbia alleging that FDA has “wrongfully withheld agency records requested by [ViroPharma] by failing to comply with the statutory time limit for …
By Jamie K. Wolszon – FDA’s recent decision to require a Risk Evaluation and Mitigation Strategy (“REMS”) for two prescription oral sodium phosphate (“OSP”) products raises questions regarding the impact the agency’s evolving application of its new REMS authority will have in instances where both …
