By Jennifer D. Newberger – On Tuesday, April 17, 2012, Senators Burr and Coburn introduced the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act, or the “PATIENTS’ FDA Act.” This bill is intended to complement the proposed user fee agreements negotiated between FDA and …
By Kurt R. Karst – Carrying through on his promise to introduce legislation to legislatively overturn the U.S. Supreme Court’s June 23, 2011 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), Senator Patrick Leahy (D-VT), along with co-sponsor Sens. Al Franken (D-MN), Jeff …
By Kurt R. Karst – In a 2-1 panel decision handed down by the U.S. Court of Appeals for the Federal Circuit earlier this week, the Court affirmed a September 2010 Judgment on the Pleadings by the U.S District Court for the Southern District of New …
By Kurt R. Karst – The wait is over. In a unanimous decision delivered by Justice Elena Kagan (along with a concurring opinion from Justice Sonia Sotomayor) on April 17, 2012, the Court held in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S that “[a] generic …
By Kurt R. Karst – Last Friday, ViroPharma Incorporated (“ViroPharma”) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s approval of three ANDAs for generic versions of ViroPharma’s VANCOCIN (vancomycin …
By Karla L. Palmer – Franck’s Lab Inc., a pharmacy that compounds veterinary drugs and whose bulk animal drug compounding activities were vindicated by a Florida federal district court last year, recently filed its Brief for the Appellees in the matter of United States v. Franck’s …
By Kurt R. Karst – In what might be the longest citizen petition response of all-time (87-pages!), FDA, on April 9, 2012, largely denied a March 17, 2006 petition for stay of action (here and here) (Docket No. FDA-2006-P-0007) submitted by ViroPharma Incorporated (“ViroPharma”) concerning the …
By Kurt R. Karst – It was yet another exciting day in the Hatch-Waxman world when news broke Wednesday morning that Teva Pharmaceuticals USA, Inc. (“Teva”) and Cephalon, Inc. (“Cephalon”) filed a Complaint and Motions for a Temporary Restraining Order and Preliminary Injunction against FDA in …
By Kurt R. Karst – We recently got our hands on a copy of the latest report FDA submitted to Congress on citizen petitions covered by FDC Act § 505(q). The report, titled “Third Annual Report On Delays In Approvals Of Applications Related To Citizen …
By Kurt R. Karst – Fans of Saturday Night Live know popular Weekend Update correspondent Oscar Rogers (played by Kenan Thompson) and his three-step approach to addressing important issues of the day: Step 1: Fix. Step 2: It. Step 3: FIXIT! That approach sums up the …
By Alan M. Kirschenbaum – Two days ago, during argument before the Supreme Court on the Affordable Care Act ("ACA"), Justice Breyer referred to “loads” of miscellaneous provisions of the Act outside the core insurance provisions. One of these is section 6004, which requires manufacturers and …
By Kurt R. Karst – Last week, the New York Times ran an editorial calling on Congress to enact legislation to address the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011). In Mensing, the Court ruled …
By Kurt R. Karst – In litigation that moved at breakneck speed on March 28, 2012, Judge Beryl A. Howell of the U.S. District Court for the District of Columbia denied AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) Motion for Temporary Restraining Order (Complaint here) seeking to vacate FDA’s …
By Kurt R. Karst – In a decision and accompanying Order handed down on March 27, 2012, Judge Richard J. Leon of the U.S. District Court for the District of Columbia ordered that FDA “immediately notify any and all state correctional departments which it has reason …
By Kurt R. Karst – In a decision that if left intact could have far-reaching implications for FDA, the U.S. District Court for the Southern District of New York recently granted a Motion for Summary Judgment filed by the National Resources Defense Council (“NRDC”) and three other …
