Yesterday, the U.S. House of Representatives Committee on Energy and Commerce released a Discussion Draft of the "Food and Drug Administration Globalization Act of 2008." The “Discussion Draft is meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure …
Recently, calls have been mounting for FDA to require manufacturers of cosmetics to highlight the presence in their products of what are variously referred to as “nanomaterials,” “nanoingredients,” and “nanoscale materials,” among other descriptors. The objective of this requirement would be to enable consumers to …
In a previous post we opined that § 912 of the FDA Amendments Act (“FDAAA”) could represent a fundamental shift in the dividing line between foods and drugs. For our most recent thoughts on that subject, we refer you to the column we recently published …
Earlier this month, FDA announced the release of the Agency’s draft Prescription Drug User Fee Act (“PDUFA”) IV Drug Safety Five-Year Plan. The draft plan is one of the goals FDA agreed to under PDUFA IV, which is the latest reauthorization of PDUFA that was …
Earlier today, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva. This case concerns the relisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange …
On April 2, 2008, upon FDA’s request, federal agents seized more than $1.3 million in dietary supplements from LG Sciences, LLC of Brighton, Michigan. According to FDA’s news release, the seized products contained “unapproved food additives and/or new dietary ingredients for which there [was] inadequate …
Earlier today, the U.S. Court of Appeals for the Third Circuit issued its much anticipated opinion in Colacicco v. Apotex, Inc. (Several parties, including FDA, entered and argued the case as amici for the appellee.) The case concerns whether actions taken by FDA pursuant to …
Last month, the U.S. Court of Appeals for the Fourth Circuit held that the whistleblower protection provisions of the Sarbanes-Oxley Act, 18 U.S.C. § 1514A, did not protect a former employee of Wyeth who alleged that he was fired for complaining to Wyeth management about …
On March 31, 2008, FDA published a Federal Register notice announcing the availability of Compliance Policy Guide (“CPG”) § 500.500, which sets “guidance levels” for 3-MCPD in acid-hydrolyzed protein (“acid-HP”) and Asian-style sauces. 3-MCPD is a chloropropanol, and chloropropanols have been identified as carcinogens. Under …
On March 24, 2008, FDA asked the U.S. District Court for the District of Connecticut to dismiss a January 22, 2008 Amended Complaint alleging that the Agency improperly denied HiFi DNA Tech, LLC’s petition for reclassification of an HPV nested DNA polymerase chain reaction (PCR) …
Earlier this year, we reported on the U.S. District Court for the District of Columbia’s January 24, 2008 order dismissing Nu-Pharm Inc.’s complaint against FDA seeking declaratory and emergency injunctive relief with respect to Nu-Pharm’s ANDA #77-615 for a generic version of Abbott Laboratories’ DEPAKOTE …
In our October 2007 summary and analysis of the FDA Amendments Act (“FDAAA”), Hyman, Phelps & McNamara, P.C. noted that FDAAA § 912, concerning a new prohibition against foods to which drugs or biological products are added, is “of potential significance to the development of …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack and John R. Fleder discusses a recent court ruling showing the potential perils faced by a company and its officers who aggressively defend their position. In United States v. Kaminski, the …
Welcome to the wonderful world of blogging, Dr. von Eschenbach! Yep, just like his boss, Department of Health and Human Services Secretary Michael Leavitt, who started “Secretary Mike Leavitt’s Blog” last year, FDA Commissioner, Dr. Andrew von Eschenbach, has started a blog as well – …
On March 21, 2008, the California EPA Office of Environmental Health Hazard Assessment (“OEHHA”) announced a workshop scheduled for April 18, 2008 to seek public input on the potential regulation of nutrients, such as vitamins and minerals, under Proposition 65 (the Safe Drinking Water and …
