By Kurt R. Karst – In a notice that will appear in the Federal Register later this week, FDA is announcing the establishment of a public docket (Docket No. FDA-2014-N-0032) to receive input and suggestions on ways to improve the quality of ANDAs (original, amendments, and …
By Jeffrey N. Wasserstein & Delia A. Stubbs – For years, those of us who followed FDA’s attempt to provide guidance related to social media felt like Vladimir and Estragon from Samuel Beckett’s Waiting for Godot. FDA initially promised guidance by the end of 2010. But, …
By Kurt R. Karst – It’s been quite some time since FDA established a public docket soliciting comment on an ANDA approval/Hatch-Waxman issue. But FDA revived the process earlier this week when the Agency issued a “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of …
By Kurt R. Karst – So much of what we do and think about each day inevitably leads us back to one topic: Hatch-Waxman. Take, for example, Polar Vortex 2014. That recent event got us thinking about two things: Snowmageddon 2011, and how warm we hope …
By Kurt R. Karst – With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit …
By Karla L. Palmer – FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 …
By Kurt R. Karst – Sandoz Inc. (“Sandoz”) is appealing to the U.S. Court of Appeals for the Federal Circuit (Docket No. 14-1693) a November 2013 decision from the U.S. District Court for the Northern District of California granting Amgen Inc.’s (“Amgen’s”) and Hoffmann-La Roche Inc.’s …
By Kurt R. Karst – Last week, in an unusual move, the U.S. Court of Appeals for the Federal Circuit waded into non-patent territory when the Court issued its decision in Allergan, Inc. v. Athena Cosmetics, Inc. (Case No. 2013-1286), a consolidated appeal of several decisions …
By Kurt R. Karst – In a recent memorandum to Center for Drug Evaluation and Research (“CDER”) staff (reprinted below, and a condensed version of which was posted on FDA’s website, here), CDER Director Janet Woodcock, M.D. announced that the Department of Health and Human Services …
By Kurt R. Karst – There’s a hot debate brewing over whether or not a biosimilar biological product licensed under Section 351(k) of the Public Health Service Act (“PHS Act”), as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), should share the …
By Kurt R. Karst – In a recent Complaint filed in the U.S. District Court for the Western District of Washington (at Seattle), several trade groups – the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Generic Pharmaceutical Association (“GPhA”), the Biotechnology Industry Organization (“BIO”), and …
By Kurt R. Karst – Last week, FDA announced the issuance of a long-anticipated draft guidance document, titled “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,” providing details on acceptable physical attribute differences between generic drugs and their NDA Reference Listed Drug (“RLD) …
By Kurt R. Karst – On December 12th, a group of bipartisan lawmakers led by Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013 (“ADAPT Act”). If enacted, the ADAPT Act would, among other …
By Kurt R. Karst – Congress has been silent on new legislation addressing drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) since the U.S. Supreme Court issued its June 2013 opinion in Federal Trade Commission v. Actavis, Inc., 570 U.S. ___ (2013). As …
By Jennifer M. Thomas – To the extent that Plaintiffs, or interested observers, hoped the District Court for the District of Columbia would seize an opportunity to take FDA to task for failing to prevent or stop drug shortages, they were disappointed by Judge Howell’s Thanksgiving …
