By Ricardo Carvajal – Earlier we blogged on the provisions of the Patient Protection and Affordable Care Act (“PPACA”) that most directly affect pharmaceutical and device manufacturers. The PPACA also contains a number of provisions that will directly and indirectly affect the food industry. Most …
By Kurt R. Karst – Late last Friday, FDA teed up the next battle over 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets when the Agency issued its 8-page decision …
By Peter M. Jaensch – On March 23, 2010, Congressman Jason Chaffetz (R-UT) introduced H.R. 4913 – the Free Speech About Science Act of 2010. The bill proposes several amendments to FDC Act § 403(r) concerning the misbranding of foods, which would have the effect …
By Kurt R. Karst – Earlier today, The Medicines Company (“MDCO”) announced that the company filed a new Administrative Procedure Act (“APA”) lawsuit in the U.S. District Court for the Eastern District of Virginia (Alexandria Division) challenging the Patent and Trademark Office’s (“PTO”) March 19, 2010 …
By Ricardo Carvajal – In a recently issued guidance document, FDA makes clear that a company with a reportable food located in multiple facilities can submit a single report to the Reportable Food Registry (RFR) instead of individual reports for each facility (a reportable food …
By Alan M. Kirschenbaum & Kurt R. Karst – On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”) (Pub. L. No. 111-148 ). A companion bill, the Health Care Education Affordability Reconciliation Act of 2010 (H.R. 4872), which …
By Kurt R. Karst – Just days after Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) issued his opinion and order vacating the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for …
By Jamie K. Wolszon & David B. Clissold – FDA published two Federal Register notices Friday, March 19th related to its oversight and regulation of cigarettes and smokeless tobacco, including a much heralded final rule to restrict the sale of cigarettes and smokeless tobacco to …
By Kurt R. Karst & Dara Katcher Levy – Last week, FDA issued Warning Letters (here and here) to Glenmark Generics (“Glenmark”) and Konec Inc. (“Konec”) for marketed unapproved and misbranded 0.3 mg, 0.4 mg, and 0.6 mg nitroglycerin sublingual tablets. According to the letters, …
By John A. Gilbert – The UN Commission on Narcotic Drugs (“CND”) held its 53rd meeting last week in Vienna, Austria. This meeting routinely coincides with the publication of the International Narcotics Control Board’s (“INCB’s”) annual report. The INCB report provides an annual summary of …
By John R. Fleder – We earlier reported that the United States Sentencing Commission issued an interesting Federal Register notice on January 21, 2010. We reported that the Commission has proposed to amend the Sentencing Guidelines to require companies to make restitution to identifiable victims, and …
By Kurt R. Karst – It has been quite a wild ride since a 3-judge panel of the D.C. Circuit issued its March 2, 2010 opinion ruling that FDA’s interpretation of the 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) fails at Chevron step one …
By Kurt R. Karst – In a March 16, 2010 opinion and order, Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) vacated the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. …
By Riëtte van Laack – For several years, the Consumers Union and the Organic Consumers Association (“Petitioners”) have urged the U.S. Department of Agriculture (“USDA”) to require that personal care products that use the term “organic” in product labeling comply with the requirements of the Organic …
By Kurt R. Karst – FDA’s recent response to a 2009 citizen petition filed by Sandoz, Inc. concerning the appropriate certification to certain Orange Book-listed patents for Takeda’s ACTOS (pioglitazone HCI) Tablets and ACTOPLUS MET (pioglitazone HCl; metformin HCI) Tablets can be summed up in …
