By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maine came one step closer to a merits ruling in a lawsuit filed last September by two Maine pharmacists, three Maine trade associations (the Maine Pharmacy Association, Maine Society of …
By Kurt R. Karst – In a May 14, 2014 Order following a hearing earlier that day, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia granted on ripeness grounds FDA’s Motion to Dismiss a lawsuit brought by Teva Pharmaceutical Industries …
By Jessica A. Ritsick & William T. Koustas – On May 8th and 9th, FDA got the ball rolling on the implementation of Title II of the Drug Quality & Security Act (“DQSA”), the Drug Supply Chain Security Act (“DSCSA”), by hosting a public workshop for …
By James C. Shehan – As previously reported here, in February 2012, FDA released three highly-anticipated guidances on biosimilars. Those of us interested in biosimilars have naturally been eagerly awaiting the next usual step in the process, the issuance of final guidances and perhaps the first …
By Kurt R. Karst – In a Complaint (and Motion for Temporary Restraining Order and Expedited Preliminary Injunction) lodged in the U.S. District Court for the District of Columbia, Teva Pharmaceutical Industries Ltd. and Teva Neuroscience, Inc. (collectively “Teva”) allege that FDA’s May 2, 2014 denial …
By Anne K. Walsh & Kurt R. Karst – Earlier this week, Hyman, Phelps & McNamara, P.C. submitted a Citizen Petition to FDA on behalf of a client requesting that the Agency determine that Ranbaxy Laboratories, Ltd. (“Ranbaxy”) has forfeited or is not eligible for first-to-file …
By Anne K. Walsh – Most news involving the False Claims Act reports that a company paid large sums of money to the government and relators to settle allegations of off-label promotion. Not so in this post about a recent decision dismissing a relator’s complaint. Not …
By Kurt R. Karst – We’ve said it before, and we’ll say it again: 180-day generic drug marketing exclusivity governed by the version of the FDC Act in effect prior to the December 2003 enactment of the Medicare Modernization Act (“MMA”) is alive and kicking. . …
By Kurt R. Karst – Earlier this week, FDA issued its highly anticipated (well, at least for this blogger) Consolidated Response to two Citizen Petitions (Docket Nos. FDA-2013-P-1397 and FDA-2013-P-0884) submitted to the Agency last year by Eisai Inc. (“Eisai”) and UCB, Inc. (“UCB”) arguing that …
By Kurt R. Karst – FDA’s recent denial of a November 2009 Citizen Petition (Docket No. FDA-2009-P-0566) submitted by the American Dental Association (“ADA”) requesting that the Agency “review and establish an appropriate regulatory classification” for the safe use of peroxide-containing tooth whiteners that lighten tooth …
By Kurt R. Karst – The battle over New Chemical Entity (“NCE”) exclusivity for Fixed-Dose Combination (“FDC”) drugs continues to heat up. In a recent Petition for Reconsideration and Petition for Stay (Docket No. FDA-2013-P-0119), Ferring Pharmaceuticals, Inc. (“Ferring”) requestes that FDA reconsider its denial of …
By James C. Shehan – The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs. In a …
By Kurt R. Karst – When FDA announced on February 21, 2014 that the Agency would, upon finalization of a draft guidance document, reinterpret the New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity for a newly approved Fixed-Dose Combination Drug …
By Kurt R. Karst – Shortly after Massachusetts Governor Deval Patrick issued a press release on March 27, 2014 announcing a Declaration of Emergency and that the Governor had directed the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, to take several actions …
By Kurt R. Karst – In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust laws by preventing generic competition for …
