By Kurt R. Karst – In a Federal Register notice scheduled for publication on August 4th, FDA will announce the Prescription Drug User Fee Act (“PDUFA”) user fee rates for Fiscal Year (“FY”) 2011. As in all previous years under the fourth iteration of PDUFA, …
On August 4, 2010, the Food and Drug Law Institute (“FDLI”) will host a webinar, titled “FDA’s (Emerging) Oversight of Laboratory-Developed Tests.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will moderate the webinar and a panel of speakers that includes FDA’s Elizabeth A. Mansfield, …
By Susan J. Matthees – POM Wonderful is still in court. The maker of POM Wonderful pomegranate juice brought suit against Coca-Cola, alleging the Coca-Cola’s Minute Maid Enhanced Pomegranate Blueberry Flavored 100% Juice Blend is misleading and deceptive to consumers because the name suggests that …
By Kurt R. Karst – On Thursday, the U.S. Senate Committee on Appropriations approved the inclusion of the “Preserve Access to Affordable Generics Act” in the report (Senate Report No. 111-238; pages 144-148 & 150-151) accompanying the Fiscal Year 2011 Financial Services and General …
By Ricardo Carvajal – FDA released a report summarizing the first seven months of the agency’s experience with its Reportable Food Registry (for more on recent developments pertaining to the RFR, see our prior posting here). The data summarized by FDA show how the potential …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the Federal Circuit denied Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd.’s (“Sun”) Petition for Panel Rehearing and Rehearing en banc of an April 14, 2010 Federal Circuit decision in …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Columbia denied Sanofi-Aventis’s Motion for Summary Judgment and granted Cross-Motions for Summary Judgment (here and here) filed by FDA and intervenor-defendants last fall in a dispute over FDA’s approval of applications …
By Alexander J. Varond* & Diane B. McColl – As noted in our blogpost less than two months ago, the U.S. District Court for the District of Columbia held that FDA acted unconstitutionally in Alliance for Natural Health, US v. Sebelius when the agency limited qualified …
By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA officials, at a July 19-20, 2010 workshop, stated that the agency intends to end the “exercise enforcement” authority over some laboratory-developed tests (“LDTs”). Put more plainly, FDA now plans to regulate some LDTs as medical …
By Kurt R. Karst – As we thought might happen, Sanofi-aventis U.S. L.L.C. (“Sanofi”) sued FDA over the Agency’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection). (On the …
By Ricardo Carvajal – As we discussed in a prior posting, Section 4205 of the Patient Protection and Affordable Care Act requires the display of certain nutrition information by chain restaurants and retail food establishments with 20 or more locations doing business under the same …
By Kurt R. Karst – On July 26, 2010, the U.S. District Court for the District of Wyoming denied a Motion for Temporary Restraining Order and Preliminary Injunction filed last week by Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) against FDA in …
By Kurt R. Karst – Earlier today, FDA issued its long-awaited response (45 pages) to a February 2003 citizen petition submitted to the Agency on behalf of Aventis Pharmaceuticals, Inc. (“Aventis”) concerning the approval of generic versions of the company’s anti-coagulant drug LOVENOX (enoxaparin sodium …
By Kurt R. Karst – Earlier this week, Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Wyoming requesting that the court enjoin FDA …
By Nisha P. Shah – A U.S. District Court recently held that misrepresentation and false description of active ingredients by a manufacturer of generic prescription vitamins can be actionable under the Lanham Act. Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, LLC. Plaintiff, Sciele Pharma, Inc., develops …
