By Kurt R. Karst – On September 15, 2009, FDA issued its long-awaited decision responding to several citizen petitions submitted in 2005 and 2006 (available here, here, here, and here) concerning the approval of ANDAs for generic versions of Wyeth Pharmaceuticals’ ZOSYN (piperacillin sodium; tazobactam sodium) …
By Ricardo Carvajal – FDA has issued a letter to the tobacco industry offering a reminder that, under the standard for cigarettes in FDCA section 907(a)(1)(A), a cigarette or any of its component parts may not contain “an artificial or natural flavor (other than tobacco or …
By Kurt R. Karst – At a September 10, 2009 Senate Judiciary Committee Executive Business Meeting, Senator Herb Kohl (D-WI) stated his plans to pursue a substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, that would make significant changes to the …
By Ricardo Carvajal – USDA’s Food Safety and Inspection Service (“FSIS”) has released a prepublication version of an Advanced Notice of Proposed Rulemaking (“ANPRM”) that seeks additional public input on the conditions under which FSIS should permit use of the claim “natural” in the labeling …
By Cassandra A. Soltis – Regrow your hair. Cure cancer. Obtain a photographic memory. These are just some of the claims that Kevin Trudeau, infomercial marketer extraordinaire, has made for various products over the years. The Federal Trade Commission (“FTC”) is all-too-familiar with Mr. Trudeau …
FDA Law Blog and Hyman, Phelps & McNamara, P.C. wish to congratulate Olsson Frank Weeda Terman Bode Matz PC on celebrating their 30th Anniversary as a food and drug law firm. Let us say, you’ve aged extremely well! We wish you much success over the …
By Kurt R. Karst – Since the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”), Hatch-Waxman scholars have wondered how FDA might answer the following question: “What is the effect of a forfeiture of 180-day exclusivity eligibility due to the …
On September 10, 2009, Hyman, Phelps & McNamara’s John R. Fleder and William T. Koustas will speak at a Thompson Interactive audioconference on FDA’s use of criminal search warrants. The audioconference, titled “Unannounced FDA Raids: Be Ready Before They Appear at Your Door,” will cover the …
For the past couple of years the American Bar Association (“ABA”) has published a list of the top 100 legal “blawgs” in the blogosphere – The ABA Blawg 100! The ABA is currently soliciting nominations for its 3rd annual list. Although FDA Law Blog was …
By Ricardo Carvajal – FDA previously announced that the Reportable Food Registry that the agency is required to establish by section 417 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") would become operational on September 8, 2009, and that responsible parties would be …
By Michelle L. Butler – On September 1, 2009, the Health Resources and Services Administration (“HRSA”) issued a Final Notice regarding qualified children’s hospitals and the 340B Drug Pricing Program. See 74 Fed. Reg. 45,206 (Sept. 1, 2009). Section 340B of the Public Health Service …
By Kurt R. Karst – On Tuesday, September 8, 2009 (just shy of the 25th anniversary of the September 24, 1984 enactment of the Drug Price Competition and Patent Term Restoration Act – i.e., the “Hatch-Waxman Act”), the U.S. Court of Appeals for the Federal …
By Douglas B. Farquhar – Pharmaceutical manufacturer Pfizer has agreed to the largest drug marketing settlement yet – $2.3 billion (yes, that is “billion” with a “b”) to resolve claims originally brought by six whistleblowers that the firm illegally marketed four drugs – according to …
By Kurt R. Karst – In a recent opinion, Judge Richard E. L. Strauss of the Superior Court of California, County of San Diego, granted motions for summary judgment ruling that Bayer AG and several generic drug manufacturers, including Barr Pharmaceuticals Inc., The Rugby Group, …
By David B. Clissold & Ricardo Carvajal – Five tobacco manufacturers including R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, and Commonwealth Brands, Inc. (the second, third, and fourth largest tobacco manufacturers in the U.S., respectively), and a retailer of tobacco products have sued FDA in a …
