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 …
By Wes Siegner & Ricardo Carvajal – The FTC has closed its investigation of Pharmavite’s advertising campaign for CholestOff dietary supplements, which contain free form phytosterols and are promoted to lower cholesterol. According to the April 2009 letter, Pharmavite used “advertising and labeling claims …
By Ricardo Carvajal – The Obama administration’s Food Safety Working Group has launched a website through which it intends to keep the public informed of its activities (to date, the only activity listed on the website is a listening session and breakout discussion among stakeholders …
By Jamie K. Wolszon & Jeffrey N. Wasserstein – The Vermont legislature recently passed S. 48, a bill that would prohibit manufacturers of prescription drug, device, and biologics products from providing certain kinds of gifts or payments to physicians and other health care providers, and …
By Kurt R. Karst – The recent addition of numerous patents to the Orange Book covering various GlaxoSmithKline (“GSK”) drug products, such as VENTOLIN (albuterol sulfate), FLOVENT (fluticasone propionate), ADVAIR (fluticasone propionate; salmeterol xinafoate), and SEREVENT (salmeterol xinafoate), begs the question why? Many of the new patent …
By Dara Katcher Levy & Roger C. Thies – For the past several years, industry has relied on Warning and Untitled Letters to determine DDMAC’s “current” thinking on the presentation of risk information in various promotional pieces. On May 26, 2009, FDA issued a draft …
By William T. Koustas & Carrie S. Martin – On May 7, 2009, FDA announced that it is requiring both approved testosterone gel products to include boxed warnings on their labels and to implement a REMS. The two products are indicated for testosterone replacement therapy …
By Michelle L. Butler – On May 20, 2009, the President signed the Fraud Enforcement and Recovery Act of 2009 (“FERA”), which is purported to be aimed at improving enforcement of fraud, including fraud related to Federal assistance and relief programs. Among other things, this …
By JP Ellison – In a Memorandum to the heads of Executive Departments and Agencies dated May 20, 2009, with the Subject Line “Preemption” (the “May 20, 2009 Memorandum”), President Obama stated that “executive departments and agencies have sometimes announced that their regulations preempt State …
