By Kurt R. Karst – Like Yogi Bear, who is always on the lookout for a better way to procure pic-i-nic baskets, we are always on the lookout for innovative strategies companies come up with to protect their market exclusivity. Two strategies have recently come by …
By Kurt R. Karst – Earlier this week, FDA announced the availability of a final guidance document, titled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act,” explaining the Agency’s interpretation of this statutory provision …
The Food and Drug Law Institute (“FDLI”) will host an intensive one-day, must-attend conference on June 24, 2011, at the Westin City Center in Washington, DC, titled “Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy.” The conference will cover myriad Hatch-Waxman issues, including 180-Day Exclusivity, …
By Nisha P. Shah & Kurt R. Karst – The U.S. Government Accountability Office (“GAO”) recently issued a report required by the FDA Amendments Act of 2007 (“FDAAA”) concerning the effects of the Pediatric Research Equity Act (“PREA”) (FDC Act § 505B) and the Best Pharmaceuticals …
By Kurt R. Karst – Last week, in a seven-page response, FDA denied an October 18, 2010 Citizen Petition submitted on behalf of Lupin Limited (“Lupin”) requesting that FDA determine that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) ANDA No. 79-081 for a generic version of COMBIVIR (lamivudine …
By Kurt R. Karst – Last Friday, Nostrum Pharmaceuticals, LLC (“Nostrum”) lodged a Complaint against FDA in the U.S. District Court for the District of New Jersey seeking declaratory and injunctive relief arising from the Agency’s decisions on pre-Medicare Modernization Act (“MMA”) 180-day exclusivity with respect …
By Kurt R. Karst – The Federal Trade Commission’s (“FTC”) drumbeat of opposition to patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) grew louder last week with the Commission’s submission of an amicus brief with the U.S. Court of Appeals for the …
By Kurt R. Karst – Last Friday, ISTA Pharmaceuticals, Inc. (“ISTA”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District Court for the District of Columbia seeking to vacate FDA’s May 11, 2011 approval of Coastal …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V. notifying them that the Bureau believes the companies violated …
Recently, we were perusing FDA-TRACK (Transparency, Results, Accountability, Credibility, Knowledge-sharing), FDA’s “web-based tool for tracking progress on key activities throughout the agency and making the information available both internally and to external stakeholders and the public,” and the FDA-TRACK Health Care Reform Dashboard in particular, …
By Robert A. Dormer – In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out” process. …
Hyman, Phelps & McNamara, P.C., Director Josephine M. Torrente will be moderating a session at the Food and Drug Law Institute’s (“FDLI’s”) upcoming 1-day conference on Risk Evaluation and Mitigation Strategies (“REMS”), which were created under the 2007 FDA Amendments Act. The FDLI conference, for …
By Kurt R. Karst – On May 10th, the U.S. District Court for the District of Columbia ruled in FDA’s favor in a case filed last July by Graceway Pharmaceuticals, LLC (“Graceway”) stemming from the Agency’s January 2010 denial of a Graceway citizen petition and approval …
By Kurt R. Karst – While we were at the American Conference Institute’s conference on Paragraph IV Disputes last week, the Federal Trade Commission (“FTC”) announced the publication of its annual summary of agreements filed with the Commission during Fiscal Year 2010 – “Agreements Filed with …
By Kurt R. Karst – FDA’s recent move to remove from the market hundreds of unapproved cough, cold, and allergy drug products has spawned two new lawsuits that might very well be one of the last hurrahs for court challenges to FDA Drug Efficacy Study Implementation-related …
