Medicure Pharma submitted a citizen petition to FDA that asserts that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) are adulterated under FDC Act § 402(f). The petition asserts that P5P (a form of vitamin B6) is a new dietary ingredient which has neither been …
Under Title II of the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension by the U.S. Patent and Trademark Office (“PTO”) if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review …
On April 11, 2008, we reported that 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 over the reslisting of U.S. Patent #5,158,952 (“the ‘952 patent”) …
Earlier this year, we reported on a provision in Title VIII of the FDA Amendments Act (“FDAAA”) requiring the responsible party of an “applicable clinical trial” (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § …
Earlier this month, we reported on the status of litigation in the U.S. Court of Appeals for the District of Columbia Circuit concerning Nu-Pharm Inc.’s efforts to get FDA to approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release …
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) …
