By Riëtte van Laack— On April 18, 2012, Rep. Leonard Lance introduced the Cosmetic Safety Amendments Act of 2012, a bill (H.R.4395) “to establish new procedures and requirements for the registration of the cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and …
By Ricardo Carvajal— The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its Second Annual Workshop on Food and Supplements on June 12 in Downers Grove, Illinois. Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will …
By Ricardo Carvajal — FDA’s second annual reportable food registry (RFR) report confirms that foodborne pathogens and undeclared allergens continue to account for the vast majority of instances of reportable food. There has been little change in the total number of primary reports submitted (i.e., initial reports …
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 Ricardo Carvajal – The USP plans to make available on its website a database of published articles that report “fraudulent activities related to food ingredients,” including foods used as ingredients (e.g., milk, honey, and olive oil). The database will also be included in tabular format …
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 Riëtte van Laack – In an April 3, 2012 letter to FDA Commissioner Dr. Margaret Hamburg, Senator Richard Durbin (D-IL) requests that FDA take action against energy drinks containing “exceptionally high” levels of caffeine and other possibly stimulating substances such as guarana and ginseng. Caffeine is …
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 Ricardo Carvajal – Warning letters issued by FDA since late February provide an indication of the types of violations that could trigger reinspection fees under the authority provided by the Food Safety Modernization Act (“FSMA”). As we noted in a prior blog posting, FSMA authorized …
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 Carmelina G. Allis – In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and …
