By Kurt R. Karst – At a September 24th Senate Judiciary Committee Executive Business Meeting, Senator Herb Kohl’s (D-WI) substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, was adopted by unanimous consent. As we previously reported, the amendment makes significant changes to …
By Kurt R. Karst – Many thanks to all of those who participated in our little Hatch-Waxman trivia contest. Although no single person was able to correctly answer all of the questions, just about all of them were correctly answered through your collective knowledge. The answers are provided …
By Kurt R. Karst – Late yesterday (Sept. 22nd), Wyeth Pharmaceuticals (“Wyeth”) sued FDA in the U.S. District Court for the District of Columbia over the Agency’s recent decision to approve two ANDAs for generic versions of ZOSYN (piperacillin sodium; tazobactam sodium) Injection. Both ANDAs …
By Kurt R. Karst – September 24, 2009 is the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act (Public Law No. 98-417) – commonly known as “Hatch-Waxman” or “Waxman-Hatch” depending on when you became familiar with the law. …
By David B. Clissold & Ricardo Carvajal – As we discussed in a prior post, the FDC Act’s ban on "characterizing flavors" in cigarettes took effect on September 22, 2009. FDA marked the occasion by issuing a press release that highlights the effects of those cigarettes …
By Alan M. Kirschenbaum – The Senate Finance Committee began today to mark up its healthcare reform bill, the America’s Healthy Future Act of 2009. In a previous post, we provided an outline of the provisions of the Chairman’s Mark that would specifically affect drug …
By Kurt R. Karst – Over the past several weeks there has been growing chatter about FDA’s Document Archiving, Reporting and Regulatory Tracking System (“DARRTS”) and how its implementation might affect generic drugs. DARRTS is a Center for Drug Evaluation and Research (“CDER”) information technology …
By Carrie S. Martin – On September 21, 2009, FDA announced in a Federal Register notice that the Agency plans to hold a public hearing to discuss issues regarding the promotion of FDA-regulated products – specifically prescription drugs, prescription biologics, and medical devices – via the …
By Kurt R. Karst – A few months ago after FDA’s approval of an NDA for the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) (amylase; lipase; protease) we queried whether FDA might apply a presumption in favor of New Chemical Entity (“NCE”) status for all PEPs, such …
By Alan M. Kirschenbaum – Today the Senate Finance Committee (“SFC”) released the Chairman’s Mark of the “America’s Healthy Future Act of 2009,” which currently is scheduled for Committee mark up next Tuesday, September 22. Among the various health reform proposals in the House and Senate, …
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 …
