By Kurt R. Karst – From time to time throughout Hatch-Waxman history the question has come up: What court decisions terminate a 30-month litigation stay arising as a result of a timely filed patent infringement action in response to a Paragraph IV certification (in either …
By Kurt R. Karst – FDA recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of …
By Karla L. Palmer – In the wake of the New England Compounding Center (“NECC”) matter, on November 2, 2012, Congressman Edward J. Markey (D-MA), senior member of the Energy and Commerce Committee, introduced legislation that will attempt to strengthen federal oversight of compounding pharmacies. NECC, …
Frank Sasinowki, Director at Hyman, Phelps & McNamara, P.C. and board member of the National Organization for Rare Disorders ("NORD"), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s ("CURED’s") first research symposium on eosinophilic gastrointestinal disorders ("EGID"). CURED is a …
By Kurt R. Karst – The recent lawsuit filed against FDA in the U.S. District Court for the District of Columbia in which Mylan Laboratories Limited and Mylan Pharmaceuticals Inc. are challenging FDA’s decision that Ranbaxy Inc. is eligible for 180-day exclusivity for its generic …
By Kurt R. Karst – When the word came out early last week that Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia ruled against FDA in litigation over 180-day exclusivity for generic versions of ACTOS (pioglitazone HCl) Tablets, we …
By John A. Gilbert & William T. Koustas – Pharmaceutical companies, wholesale distributors, FDA, and many other stakeholders have long sought a uniform national prescription “drug pedigree,” track-and-trace, and distributor licensing regime. While the Prescription Drug Marketing Act (“PDMA”) and the implementing regulations have included …
By Kurt R. Karst – A lot has been happening at FDA over the past two months – and in particular in recent weeks – as the Agency works diligently to implement the Generic Drug User Fee Amendments of 2012 (“GDUFA”). There have been various …
By Kurt R. Karst – We were hardly surprised when we learned that Momenta Pharmaceuticals, Inc. and Sandoz Inc. (“Plaintiffs-Appellees”) filed a Petition for Rehearing en banc seeking reconsideration of an August 3, 2012 decision by a divided (2-1) panel of judges from the U.S. …
By Kurt R. Karst & Jeffrey N. Gibbs – We’ve been following litigation involving the Florida veterinary compounding pharmacy Franck’s Lab, Inc. (“Franck’s”) for a couple of years. We won’t get into all of the case details here – for that, see our previous posts …
By Kurt R. Karst – The Federal Trade Commission (“FTC”) is seeking leave to file a second amicus brief in private antitrust litigation espousing the Commission’s views that a branded drug company’s commitment, as part of a settlement agreement, not to launch an Authorized Generic …
By Kurt R. Karst – It was 50 years ago today (October 10th) that President John F. Kennedy signed into law the Kefauver-Harris Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962), which amended the 1938 FDC Act to require, among other things, …
By Kurt R. Karst – In a Complaint recently filed in the U.S. District Court for the District of New Jersey, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) seek declaratory relief that Actelion is under no duty or obligation to supply prospective …
By Kurt R. Karst – Just weeks after Federal Trade Commssion (“FTC”) Chairman Jon Leibowitz signaled in a speech that the Commission would appeal to the U.S. Supreme Court the U.S. Court of Appeals for the Eleventh Circuit’s April 2012 ruling (and subsequent July 2012 …
By Kurt R. Karst – Those of us who work in the drug approval world know that a high degree of coordination among various FDA components is necessary for a smooth and efficient approval process. This is particularly true for ANDA generic drug …
