Earlier today, the White House announced that President Bush signed H.R. 3580, the FDA Amendments Act of 2007, into law. The U.S. Department of Health and Human Services subsequently issued an announcement praising the new law as "an important step forward in ensuring the safety …
Earlier today, FDA’s Office of Generic Drugs posted a letter on its website requesting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning at least one ANDA submitted to the Agency containing a paragraph IV patent certification requesting FDA approval for …
We previously reported on several cases involving FDA-regulated products and certain preemption of state law issues. Yesterday the Supreme Court agreed to hear (i.e., granted Cert. [see page 5]) in one of those cases – Warner-Lambert v. Kent. The case concerns Warner-Lambert’s REZULIN (troglitazone), certain …
Specialty Distribution Services (“SDS”), a corporate subsidiary of Express Scripts, Inc., has admitted to violations of FDC Act § 303(e) and agreed to pay $10.5M as part of a 36-month deferred prosecution agreement with the U.S. Attorney’s Office for the District of Massachusetts in connection …
The United Nations (“UN”) drug control system is given authority, through treaties (called “conventions”), to establish international controls and monitor medicines that are subject to abuse. Member countries that are signatories to the conventions are committed to control substances at the same level as dictated …
Late today, the U.S. Senate passed FDA reform legislation by unanimous consent. The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007. Earlier in the day there was some concern that the Senate vote on the …
House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012. Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …
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 …
