By Ricardo Carvajal – Totally Wicked-E.Liquid (“TWI”), an importer and distributor of electronic cigarettes, filed suit to prevent FDA from regulating TWI’s electronic cigarettes as drugs, devices, or combination products, and from barring their importation into the U.S. TWI claims that the nicotine in its product …
By Peter M. Jaensch & John A. Gilbert – Since the passage of the federal Combat Methamphetamine Epidemic Act in 2005 and state legislation adopted in most states around the same time, retail sales of over-the-counter (“OTC”) cold and allergy products containing pseudoephedrine (“PSE”) have been subject to …
By Kurt R. Karst – The tome that is the President’s Budget for Fiscal Year 2012 is chock-full of new proposals that, if implemented, would significantly affect both brand-name and generic drug manufacturers. What first caught our attention were some statements in an overview of the proposed …
By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health (“CDRH”) has proposed the “Innovation Pathway Program” for breakthrough medical devices. CDRH says it will review these products in 150 days or less, which the agency claims is nearly half the review time of …
By Riëtte van Laack – Over the past two years, we have noted several joint or coordinated actions by FDA and FTC. The agencies issued their own warning letters to the same manufacturers at the same time (here and here), and, on several occasions, FDA and …
By Kurt R. Karst – Late last year, Impax Laboratories, Inc. (“Impax”) filed a Complaint in the U.S. District Court for the District of New Jersey seeking a judgment with respect to U.S. Patent No. 6,911,217 (“the ‘217 patent”). The ‘217 patent is one of four …
By Susan J. Matthees – Six inmates on death row in three different states sued FDA in the U.S. District Court for the District of Columbia over the importation of thiopental sodium, one of the drugs used by some states to administer a lethal injection. The …
By Cassandra A. Soltis – The Dietary Guidelines for Americans, 2010 (the 2010 Dietary Guidelines), released by the federal government last week, were clearly drafted with the U.S. obesity epidemic in mind. In addition to encouraging consumers to exercise more and reduce calorie consumption, the guidelines …
By Peter M. Jaensch – In what appears to be yet another example of a consumer fraud class action that cites alleged violations of the FDC Act and its implementing regulations, on February 1, 2011, Athena Hohenberg filed a class action lawsuit in U.S. District Court …
By Anne K. Walsh – Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor …
By Kurt R. Karst – The drama in the decade-old fight over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) has taken yet another turn. The U.S. Court of Appeals for the Federal Circuit …
By Kurt R. Karst – The ANDA backlog in FDA’s Office of Generic Drugs (“OGD”) continued to grow unabated in 2010. OGD started out the year with a backlog of 1963 original applications and ended the year up almost 400 applications, for a grand total of …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch discusses the increasing use of the False Claims Act ("FCA") to privately prosecute what are actually violations of the FDC Act, and examines the allegations underlying the recent GlaxoSmithKline …
By Ricardo Carvajal – Senator Patrick Leahy (D-VT) reintroduced legislation to strengthen criminal penalties for food safety violators in the form of the Food Safety Accountability Act of 2011. As with the version of the bill introduced last year, the current version would amend Title 18 …
By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) was busy in 2010! According to recent data obtained by FDA Law Blog, after a banner year in 2009 in which OOPD surpassed the 2,000 orphan drug designation mark and designated a near-record 160 …
