By David B. Clissold – In a federal lawsuit filed on Friday, February 25, 2011 in the District of Columbia, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the FDA, DHHS, Kathleen Sebelius, Margaret Hamburg, and Lawrence Deyton for declaratory and injunctive relief …
By Kurt R. Karst – In a win for compounding pharmacies and a loss for FDA, the U.S. Court of Appeals for the Fifth Circuit ruled last week in Med. Ctr. Pharmacy v. Holder that the U.S. District Court for the Western District of Texas violated …
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act § 201(ff)(3)(B) or § 301(ll) acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements …
By Kurt R. Karst – It was just yesterday that we commented on how folks in the Hatch-Waxman community have been patiently awaiting FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic …
By Ricardo Carvajal – In a letter directed to Attorney General Eric Holder, Senator Patrick Leahy (D-VT) asked the U.S. Department of Justice (“DOJ”) for an update on its investigation of the Peanut Corporation of America (“PCA”) and its president, Stewart Parnell. According to the letter, FDA …
By Kurt R. Karst – As folks in the Hatch-Waxman community patiently await FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) with skinny labeling that omits, via …
By Peter M. Jaensch – United States Senator Charles Schumer (D-NY) recently introduced legislation that is intended to prevent sales of recalled biologics, drugs, medical devices, infant formula, and foods. However, if that legislation is enacted it may actually dissuade companies from undertaking voluntary recalls. On February …
By Kurt R. Karst – Last week, substantively identical legislation was introduced in both the U.S. House of Representatives and in the U.S. Senate to amend the FDC Act to prohibit the manufacture, marketing, sale, or distribution of an authorized generic version of an NDA-approved drug …
By Riëtte van Laack – As previously reported, on Dec. 8, 2010, FDA published a proposal to amend the interim final rule ("IFR") governing health claims concerning the risk of cardiovascular heart disease and consumption of phytosterols (see 21 C.F.R. § 101.83). FDA stated that, as …
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 …
