Many pharmaceutical manufacturers are already struggling under the regulatory burden associated with the various requirements of state gift reporting statutes. That burden may soon be made heavier. Earlier this month, Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) introduced legislation that would require drug, biologic, …
Earlier today, the U.S. District Court for the District of Columbia denied Apotex’s motion for a temporary restraining order and preliminary injunction in a case against FDA involving Apotex’s ANDA for a generic version of AstraZeneca’s PRILOSEC (omeprazole) Delayed-Release Capsules and the effects of AstraZeneca’s …
FDA announced on September 14, 2007 the release of a final guidance document pertaining to analyte specific reagents (“ASRs”), titled “Guidance for Industry and FDA Staff – Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions” (“the ASR Guidance”). A draft version of this guidance …
On September 10, 2007, the U.S. Department of Justice announced that French pharmaceutical company Sanofi-Aventis (“Aventis”), formerly Aventis Pharmaceuticals Inc., agreed to pay $190 million to settle allegations that the company caused false claims to be filed with Medicare and other federal health programs. The …
Last month we reported on a highly anticipated ruling in a case concerning whether a New York City health code regulation requiring restaurants to post calorie content values on menus and menu boards is preempted by the Nutrition Labeling and Education Act of 1990 (“NLEA”). …
In a September 7, 2007 “Legal Opinion Letter” published by the Washington Legal Foundation, attorneys Arnold I. Friede and John F. Kamp criticize legislation introduced earlier this year that would disallow a tax deduction for certain Direct-To-Consumer (“DTC”) prescription drug advertisements. The bill, H.R. 2823, …
On August 29, 2007, the U.S. District Court for the District of Massachusetts denied a motion for class certification in ongoing litigation concerning Parke-Davis’s (a then-Warner-Lambert and now-Pfizer subsidiary) anticonvulsant drug product NEURONTIN (gabapentin). The suit, filed in May 2004, alleges that Parke-Davis was involved …
Over the summer we posted on several preemption cases involving FDA-regulated products. In July, we reported that the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant …
On August 27, 2007, FDA published its long-awaited proposed rule to amend the final monograph for Over-the-Counter (“OTC”) sunscreen drug products. The rule, if finalized, would set standards for formulating, testing, and labeling OTC sunscreen drug products with Ultraviolet A (“UVA”) light and Ultraviolet B …
On August 1, 2007, the U.S. Court of Appeals for the Federal Circuit affirmed (errata) the U.S. District Court for the District of Columbia’s December 2005 ruling declaring that the District of Columbia’s Prescription Drug Excessive Pricing Act of 2005 (the “Act”) is preempted by …
Hyman, Phelps & McNamara, P.C. is pleased to announce that J.P. Ellison has joined the firm as Of Counsel. Mr. Ellison joins HPM from the U.S. Department of Justice Office of Consumer Litigation (“OCL”). By regulation, OCL has responsibility for representing the FDA, Federal Trade …
Hyman, Phelps & McNamara, P.C.’s Brian J. Donato cautioned companies about the dangers of “residual risk” while speaking at a recent conference on risk management sponsored by AdvaMed. Medical Device & Diagnostic Industry reported on the speech in an August 2007 article. Residual risk, which …
The U.S. District Court for the Southern District of New York is expected to decide soon whether a New York City regulation requiring restaurants to post calorie content values on menus and menu boards is preempted by the Nutrition Labeling and Education Act of 1990 …
Earlier today, FDA announced that Tim Coté, M.D., M.P.H., a Captain in the U.S. Public Health Service, has accepted the position of Director of the Agency’s Office of Orphan Products Development (“OOPD”). Dr. Coté is only the fourth OOPD Director since the office was created …
Since FDA announced its current enforcement policy for marketed unapproved drug products in a June 2006 Compliance Policy Guide (“CPG”), the Agency has taken various company- and product-specific enforcement actions. We have previously reported on some of these enforcement actions (here, here, and here). FDA …
