By Riëtte van Laack – The FDA Amendments Act (“FDAAA”) amended the Food, Drug, and Cosmetic Act (“FDC Act”) to create section 417, which directs FDA to establish a Reportable Food Registry (“Registry”). The purpose of the Registry is to provide a “reliable mechanism to …
By Kurt R. Karst & Frank J. Sasinowski – FDA’s recent decision to approve the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) to help patients with cystic fibrosis and others with Exocrine Pancreatic Insufficiency (“EPI”) digest and absorb nutrients from foods has apparently left the Agency …
By Jamie K. Wolszon – Earlier this month, a U.S. District Court for the Northern District of California judge refused to dismiss a criminal indictment of the former Chief Executive Officer (“CEO”) of InterMune for misbranding and wire fraud charges connected to the off-label promotion …
By Ricardo Carvajal – In an increasingly common exercise of the agency’s authority under FDC Act § 404, FDA announced that is has it has suspended the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc. in April 2008. Under § 404 …
By Kurt R. Karst – Will FDA apply the Agency’s pre-Medicare Modernization Act (“MMA”) “holding-on-the-merits standard” to the post-MMA “failure to market” 180-day exclusivity forfeiture provisions? It is a reasonable question, and one that FDA has not yet definitively answered. Nevertheless, there appears to be …
On June 12th, the U.S. House of Representatives voted 307-97 on final passage of H.R. 1256 – The Family Smoking Prevention and Tobacco Control Act. The U.S. Senate overwhelmingly passed the bill on June 11th with a 79-17 vote. President Obama is expected to sign …
By Ricardo Carvajal – Much ink has already been spilled detailing the burdens that draft federal food safety legislation would impose on industry (click here for the latest version of the Food Safety Enhancement Act of 2009 (“FSEA”)). Little has yet been said about the burdens …
By Kurt R. Karst – On June 10th, the Federal Trade Commission (“FTC”) announced the release of its highly anticipated report on Follow-On Biologics (“FOBs”). The 120-page report, titled “Emerging Health Care Issues: Follow-On Biologic Drug Competition” is the product of an FTC Roundtable held …
By Kurt R. Karst – The U.S. Court of Appeals for the Federal Circuit’s recent decision in Abbott Labs. v. Sandoz, Inc. concerning U.S. Patent No. 4,935,507 (“the ‘507 patent”) covering OMNICEF (cefdinir) has been discussed at length in the blogosphere for its possible implications …
By Kurt R. Karst – Galderma Laboratories L.P. (“Galderma”) recently submitted a citizen petition to FDA (also see our Citizen Petition Tracker) requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval of …
By Kurt R. Karst – Recent decisions by the U.S. District Court for the Eastern District of Virginia and the U.S. District Court for the District of Columbia in PhotoCure ASA v. Dudas and Wyeth Holding Corp. v. United States, respectively, concerning certain Patent Term Extension …
By Jamie K. Wolszon – FDA has announced the establishment of a cross-agency task force to craft recommendations on how to increase transparency regarding the agency’s operations, activities, processes and decisionmaking, including product approvals, enforcement actions, and product recalls, while protecting confidential information. The agency …
FDA recently launch a redesigned website that is aimed at improving the “look and feel” of all FDA websites. According to the Agency: The new site organization is intended to allow you to find information more quickly: Information is categorized by topic for easier retrieval, with …
The thought of federal agents storming the offices of an FDA-regulated company may seem far-fetched to some, but it is becoming a common reality, according to Hyman, Phelps & McNamara, P.C. attorneys John R. Fleder and William T. Koustas in a recent article in FDLI's Update publication. …
By Susan J. Matthees – Last week, FDA announced a new grant program available to help support the development of new animal drugs to treat minor species or minor disease in major species (horses, dogs, cats, chickens, turkeys, cattle and pig). The Minor Use and Minor …
