By Wes Siegner – In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.” Chapter II of this guidance contains FDA’s views on how to fulfill the statement of identity requirement for dietary supplements contained in 21 C.F.R. § …
By Cassandra A. Soltis & Wes Siegner – Previously we have commented on FDA’s draft guidance originally issued on January 2, 2008 and recently reissued again in draft form on December 11, 2008 (here and here). Both draft guidance documents assert that, in the Dietary …
By Riëtte van Laack – The Eastern District Court of California enjoined California from enforcing California's Penal Code Section 599f against federally inspected swine slaughterhouses on the ground that section 599f is expressly preempted by the Federal Meat Inspection Act (“FMIA”). Section 599f prohibits a slaughterhouse …
By Cassandra A. Soltis – A settlement agreement reached between numerous state attorneys general and Coke, Nestle, and Beverage Partnership Worldwide makes clear that it is not just the Federal Trade Commission that is scrutinizing weight loss claims. The target of the attorneys general action …
By Susan Matthees and Jeff Wasserstein – Although the stimulus bill that President Obama recently signed into law received significant attention for its economic implications, less noticed was Title XIII of the stimulus bill, entitled the "Health Information Technology for Economic and Clinical Health Act" or …
By Douglas B. Farquhar – More than nine years after passage of federal legislation that would permit individuals to legally import prescription drugs from Canada, the Obama Administration appears ready to open the door to importation. Prior administrations, including President Clinton’s, prevented individuals from legally …
By Kurt R. Karst – Actavis Elizabeth LLC (“Actavis”) has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year. FDA’s Orange Book shows that VYVANSE is a Type …
By Alan M. Kirschenbaum – Last week we reported on the Obama Administration’s 10-year budget proposal, focusing on the Department of Health and Human Services budget. As noted, the budget establishes a reserve fund of over $630 billion over 10 years to finance health care reform. …
By Kurt R. Karst – Over the past few weeks, we have posted (here and here) on citizen petitions submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version …
By Cassandra A. Soltis & Alan M. Kirschenbaum – Today the Obama Administration released a summary of its 10-year budget proposal entitled “A New Era of Responsibility – Renewing America’s Promise.” The document provides a high level outline of priorities – details reportedly will be released in April. …
By Kurt R. Karst – Earlier today, FDA announced that the Agency was taking the unusual step of invoking its Application Integrity Policy (“AIP”) against Ranbaxy Laboratories Limited’s (“Ranbaxy”) Paonta Sahib manufacturing facility in India. FDA takes such regulatory action under the Agency’s AIP procedures …
By James P. Ellison – We previously reported on FDA's Federal Register notice adjusting its civil penalties for inflation and noted our prior posts on the new civil penalty authority given to FDA in the FDA Amendments Act. As we explained in our earlier post, FDA's …
By Kurt R. Karst – In a rare move, the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision extending a 30-month stay available under the Hatch-Waxman Amendments with respect to Teva Pharmaceutical USA, Inc.’s ANDA for a generic version of …
By Kurt R. Karst – We previously reported on a citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of DORYX (doxycycline hyclate) Delayed-Release Tablets, an …
By Ricardo Carvajal— During a session at the Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, senior FDA staff confirmed that the agency does not intend to issue regulations specific to products derived through nanotechnology, or to establish a definition …
