By Kurt R. Karst – We were eager to delve into the Federal Circuit’s recent 2-1 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Docket Nos. 2012-1062, -1103, -1104) concernng the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1), particularly in …
By Kurt R. Karst – There’s a lot of parlance (legal and scientific) bandied about in the food and drug world, and perhaps nowhere more so than in the world of Hatch-Waxman. Things can get confusing. Take, for example, the term “Reference Listed Drug,” or “RLD.” FDA’s …
By Riëtte van Laack – The U.S. Government Accountability Office ("GAO") released a report on FDA’s food recall process prepared in response to a congressional directive in the Food Safety Modernization Act ("FSMA"), which provided FDA with mandatory recall authority for foods. In evaluating FDA’s implementation, the …
By Ricardo Carvajal – According to an informal policy, FDA considers the use of the term “natural” in food labeling to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally …
By Jamie K. Wolszon – FDA published in the July 31, 2012 Federal Register a notice announcing the Fiscal Year (“FY”) 2013 rates pursuant to the third iteration of the Medical Device User Fee Act (“MDUFA III”), which was recently enacted as part of the FDA …
By Kurt R. Karst – Ever since the U.S. Court of Appeals for the First Circuit issued its opinion in May 2012 in Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012) denying Mutual Pharmaceutical Company’s (“Mutual’s”) appeal of …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new …
By Riëtte van Laack – The Patient Protection and Affordable Care Act of 2010, in part, amended the FDC Act by adding Section 403(q)(H) requiring restaurants and similar retail food establishments (“SRFEs”) that are part of a chain with 20 or more locations to provide calorie …
By Jennifer D. Newberger – The Medical Device User Fee Amendments of 2012 ("MDUFA III") require FDA to “publish guidance outlining electronic copy of submissions ("e-Copy") and objective criteria for revised ‘refuse to accept/refuse to file’ checklists.” On July 30, 2012, FDA issued a draft guidance …
By Kurt R. Karst – In two Federal Register notices (here and here) scheduled for publication on August 1st, FDA will announce the Fiscal Year (“FY”) 2013 user fee rates pursuant to the fifth iteration of the Prescription Drug User Fee Act (“PDUFA”) and pursuant to …
By Karla L. Palmer & Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a Final Rule on July 30th (77 Fed. Reg. 44,456 (July 30, 2012) placing prostanozol and methasterone into Schedule III of the federal Controlled Substances Act (“CSA”) as anabolic steroids. DEA’s administrative scheduling of prostanozol and …
By Wes Siegner – The article “‘Medical Foods’ and Supplements for Brain Health Advance” that recently appeared in The Wall Street Journal provides important insights into a growing industry that is focused on offering a wider range of healthcare options. However, the article contains common misconceptions …
By Karla L. Palmer & Larry K. Houck – Drug Enforcement Administration (“DEA”) Administrator Michele M. Leonhart, accompanied by officials from Internal Revenue Service Criminal Investigations (Richard Weber), Immigration and Customs Office of Homeland Security (James Chaparro), and U.S. Postal Inspections, held a press conference yesterday announcing …
By John R. Fleder – On July 27, 2012, the United States Court of Appeals for the D.C. Circuit issued its long-awaited ruling in Friedman v. Sebelius, No. 11-5028. The case involves a challenge to a decision by the Secretary of Health and Human Services (“HHS”) …
By Douglas B. Farquhar – In a rare request for a court to review FDA’s failure to clear a medical device for market distribution, arguments have been finalized, briefs have been filed, and oral argument has been scheduled for September 21, 2012. The case, filed in the U.S. …
