By Kurt R. Karst – Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new …
By Etan J. Yeshua & Kurt R. Karst – Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions. In doing so, Judge Edward R. Korman of …
By Kurt R. Karst – A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the …
By Kurt R. Karst – Despite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter. If a company – or FDA – misses a deadline by just one day, …
By Kurt R. Karst – A recent per curiam decision from the U.S. Court of Appeals for the District of Columbia Circuit may be the last word in litigation Hill Dermaceuticals, Inc. (“Hill”) initiated in November 2011 against FDA, as Hill filed a petition for …
By Kurt R. Karst – Excitement is running high in the pharmacetical world with just hours to go before the U.S. Supreme Court hears oral argument on Monday, March 25, 2013 in Federal Trade Commission v. Actavis (Docket No. 12-416) concerning whether drug patent settlement …
By Kurt R. Karst – Over the past week we’ve been inundated with new items concerning generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers. …
By Alexander Varond – On March 12, 2013, FDA released a draft version of a revision to the February 2000 final guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level.” We refer to the draft version as “Revision 1.” Revision 1 retains the original …
By Kurt R. Karst – Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA …
By Kurt R. Karst – We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the …
By Karla L. Palmer – The National Association of Attorneys General (“NAAG”) today sent a letter to the U.S. Food and Drug Administration’s Margaret Hamburg urging the Agency to adopt standards requiring manufacturers and marketers of generic prescription opioids to develop tamper-resistant versions of such products. …
By Kurt R. Karst – Earlier ths week, Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC (collectively “Counterclaim Plaintiffs”) filed their opposition to Actelion Pharmaceuticals Ltd.’s and Actelion Clinical Research, Inc.’s (collectively “Actelion’s”) Motion for Judgment on the Pleadings and to Dismiss Counterclaims in …
By Kurt R. Karst – Finally! A Hatch-Waxman lawsuit that is not overly complex and not difficult to unravel. Late last week, Sun Pharma Global FZE, Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceuticals Industries, Ltd. (collectively “Sun”) filed a Complaint and a Motion for a …
An article published by Law360 and co-authored by H. Keeto Sabharwal and Dennies Varughese of Sterne Kessler Goldstein & Fox PLLC, and Kurt R. Karst of Hyman Phelps & McNamara PC, examines whether, and to what extent, a successful Inter Partes Review (“IPR”) challenge by a …
By Kurt R. Karst – In a widely anticipated move, Momenta Pharmaceuticals, Inc. and Sandoz Inc. have petitioned the U.S. Supreme Court to review the August 3, 2012 judgment of the U.S. Court of Appeals for the Federal Circuit, in which a divided (2-1) Federal …
