By Kurt R. Karst – A recent report from Leerink Swann LLC analyst Howard Liang, Ph.D. suggests that what appears to be a recent increase in the number of Refuse-to-File (“RTF”) letters issued by FDA to NDA and BLA sponsors – some of which are large, …
By John A. Gilbert, Jr. & Peter M. Jaensch – In a press conference at the National Press Club on April 19, 2011, the Administration presented its action plan (“Plan”) to address concerns about the increase in prescription drug abuse. The Plan is entitled: “Epidemic: Responding to …
By William T. Koustas – On Tuesday, April 19, 2011, after years of debate and several public meetings, FDA released the final Risk Evaluation and Mitigation Strategy ("REMS") it will require for all extended-release opioid medications. The final REMS was issued as part of the White …
By Kurt R. Karst – A recent amendment to the America Invents Act (H.R. 1249) introduced by Representative John Conyers (D-MI) and passed by voice vote during a markup of the bill last week by the House Committee on the Judiciary would give The Medicines Company …
By Kurt R. Karst – On April 15th, Judge Ellen S. Huvelle of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a Complaint filed last September by ViroPharma Incorporated (“ViroPharma”) in connection with the approval of ANDAs for generic versions …
By Nisha P. Shah – On April 13, 2011, FDA issued a proposed rule that would expand the scope of clinical investigator disqualification. 76 Fed. Reg. 20575, Apr. 13, 2011. The proposed changes are in response to a September 2009 report by the Government Accountability Office …
By Kurt R. Karst – Since the U.S. Court of Appeals for the Federal Circuit issued its December 2009 decision in Forest Group, Inc. v. Bon Tool Co. concerning the maximum $500 per violation penalty for intentionally falsely marking a product (in that case, spring-loaded parallelogram …
By Kurt R. Karst – FDA has responded to requests included in two reports accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (Public Law No. 111-80) – House Report No. 111-279 and Senate Report 111-39 – requesting information …
By Kurt R. Karst – On occasion we dream about Hatch-Waxman and wake up in the morning with a burning question. One of the recent questions we wondered about is whether FDA would take the position that an ANDA sponsor who amends a long-pending ANDA to …
By Roger C. Thies – On March 30, 2011, FDA publicly announced that it would not take enforcement action under certain conditions against pharmacies that compound hydroxyprogesterone caproate for injection for the reduction of the risk of certain preterm births in women who have had at …
By Kurt R. Karst – Some court decisions just leave us scratching our heads after we read them, and the decision handed down last week by Judge Freda Wolfson of the U.S. District Court for the District of New Jersey in Medeva Pharma Suisse A.G. v. …
By Kurt R. Karst – Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a pair of decisions in a long-running dispute between Lannett Company, Inc. (“Lannett”), the self-proclaimed “oldest generic drug manufacturer” in the United States (founded in 1942), and Celgene …
By Roger C. Thies – FDA announced on March 30, 2011 that it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or …
By Kurt R. Karst – Although we were not in attendance at today's argument before the U.S. Supreme Court in PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501) concerning whether certain Circuit Court decisions “abrogated the Hatch-Waxman Amendments by allowing …
By Kurt R. Karst – Late last week, Par Pharmaceutical, Inc. (“Par”) filed a Complaint in the U.S. District Court for the Eastern District of Pennsylvania seeking a declaration that two recently issued patents – U.S. Patent Nos. 7,858,122 (“the ‘122 patent”) and 7,863,316 (“the ‘316 …
