By Susan J. Matthees – FDA recently announced two new developments related to its review of proprietary name submissions. First, FDA announced the availability of a new manual of policies and procedures (“MAPP”), MAPP 6720.2: Procedures for Handling Requests for Proprietary Name Review, that details the …
By Alan M. Kirschenbaum – Last Friday the Senate Finance Committee completed its mark-up of the “America’s Healthy Future Act of 2009.” The Committee is awaiting scoring by the Congressional Budget Office before it votes on the bill this week. Earlier we reported on the original …
By Kurt R. Karst – Last week, the U.S. District Court for the District of New Hampshire ruled in a 67-page opinion that various state law tort claims brought against generic drug manufacturer Mutual Pharmaceutical Company, Inc. (“Mutual”) are not preempted by Title I of the …
By William T. Koustas – FDA recently issued its most extensive guidance for industry regarding Risk Evaluation and Mitigation Strategies (“REMS”) since their enactment of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The “Draft Guidance for Industry: Format and Content of Proposed …
By Kurt R. Karst – We previously reported on a Senate floor amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (H.R. 2997) co-sponsored by Senators Sam Brownback (R-KS) and Sherrod Brown (D-OH) that would establish within …
By William T. Koustas – The United States Court of Appeals for the District of Columbia Circuit (“Court”) recently issued an opinion affirming the FDA’s (or “Agency”) approval of the anthrax vaccine for all known routes of infection and rejected the Plaintiffs’ efforts to enjoin …
By David B. Clissold & Ricardo Carvajal – An importer and distributor of cigars has sued FDA to enjoin the agency from taking any adverse action with respect to Djarum brand cigars under Chapter IX of the FDCA until such time as the agency lawfully asserts …
By Jeff Wasserstein – We previously blogged on the effort by W. Scott Harkonen, the former CEO of InterMune, to dismiss an indictment for misbranding and fraud. That effort was unsuccessful, and Mr. Harkonen was convicted after trial of one count of wire fraud. He …
By Jeffrey K. Shapiro – FDA’s Office of Combination Products (“OCP”) recently issued a proposed rule (74 Fed. Reg. 48,423) setting forth current good manufacturing practice (“cGMP”) requirements for combination products. The proposed rule does not independently establish new requirements; rather, it clarifies which set of …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Jamie K. Wolszon and John R. Fleder explores the so-called “strict liability” criminal prosecution doctrine in FDA cases that largely derives from the 1975 U.S. Supreme Court case of United States v. Park. FDA believes …
By Douglas B. Farquhar – In a 98-page decision filed on September 23rd, the United States Court of Appeals for the First Circuit affirmed the judgment of Boston federal court Judge Patti Saris awarding certain “Medigap” insurance companies, patients and third-party payors $13 million from …
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. …
