By Kurt R. Karst – Since 2008, FDA’s annual guidance document agendas (here, here, and here) have noted FDA’s plans to issue guidance on the Agency’s so-called Pre-Launch Activities Importation Request (“PLAIR”) program. Although FDA officials have discussed PLAIRs in presentations, the Agency has not …
By Ricardo Carvajal – The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food facilities and recommends several changes, including an expansion of FDA’s statutory authority. OIG reviewed FDA's food …
By Susan J. Matthees – FDA's Center for Veterinary Medicine ("CVM") recently announced an advanced notice of proposed rulemaking (“ANPRM”) to solicit comments on possible changes to the current regulation for veterinary feed directive (“VFD”) drugs. The VFD drug category was established in 1996 as part …
By Jeffrey K. Shapiro – We are beginning to suspect that the new transparency of this Administration is a lot like the old transparency. Or, as The Who sang in We Won’t Get Fooled Again, “meet the new boss / same as the old boss.” The …
By Riëtte van Laack – Late last month, the U.S. Court of Appeals for the Ninth Circuit vacated a district court’s injunction against California’s prohibition of the use of non-ambulatory pigs for use in human consumption, Cal. Pen. Code § 599f. Last year, the district …
By Kurt R. Karst – [We interrupt this blog posting to bring you some breaking news . . . . For those of you following the battle over generic COZAAR/HYZAAR 180-day exclusivity, we updated our April 5th post with information on a D.C. Circuit decision. …
By Kurt R. Karst – When we last blogged on the issue of 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets, FDA had issued an 8-page decision concluding that Teva …
By Kurt R. Karst – FDA’s recently posted approval letter for Orchid Healthcare’s (“Orchid’s”) ANDA No. 78-357 for a generic version of Schering-Plough Corp.’s (“Schering’s”) blockbuster drug CLARINEX (desloratadine) Tablets, 5 mg, reads like any run-of-the-mill ANDA approval letter; however, it’s what is not said …
By Carrie S. Martin & Dara Katcher Levy – On March 29, 2010, FDA published a proposed rule to amend its direct-to-consumer (“DTC”) regulations to require that prescription drug advertisements present information about side effects and contraindications in a “clear, conspicuous, and neutral manner.” Current …
By Peter M. Jaensch – On March 23, 2010, Judge McMahon of the U.S. District Court for the Eastern District of New York issued a memorandum decision in U.S. Smokeless Tobacco Manufacturing Company, LLC, and U.S. Smokeless Tobacco Brands, Inc. v. City of New York denying …
By Jeffrey K. Shapiro – In October 2009, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a report entitled, “Adverse Event Reporting for Medical Devices” (“OIG Report”). The OIG’s Report has not received the attention it deserves. The OIG report …
By Riëtte van Laack – On March 25, 2010, the Food Safety and Inspection Service (“FSIS”) of the USDA published a proposed rule requiring poultry and meat establishments subject to FSIS inspection to promptly notify the authorities when an adulterated or misbranded meat or poultry …
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 …
