On September 28, 2007, the U.S. Department of Justice announced that Bristol-Myers Squibb (“BMS”) agreed to pay more than $515 Million Dollars to settle off-label promotion, anti-kickback, Average Wholesale Price (“AWP”), and Best Price (“BP”) allegations, and related False Claims Act claims. The enforcement action …
Earlier today, FDA announced a new initiative, called the Generic Initiative for Value and Efficiency (“GIVE”), which is intended to increase the number and variety of generic drug products. According to Gary Buehler, R.Ph., Director of FDA’s Office of Generic Drugs (“OGD”): GIVE is an initiative …
On September 27, 2007, the U.S. House of Representatives Committee on Energy and Commerce passed H.R. 970, the Dextromethorphan Distribution Act of 2007, after a legislative “mark-up” session. Similar legislation was introduced in the U.S. Senate in May 2007 (S. 1378) and was referred to …
On September 27, 2007, the U.S. Attorney’s Office for the District of New Jersey announced settlements with five companies (Biomet, Inc., Depuy Orthopaedics, Smith & Nephew, Inc., Zimmer, Inc., and Stryker Orthopedics, Inc.) resolving anti-kickback allegations. The allegation common to all five cases is that each …
On September 18, 2007, FDA’s Center for Drug Evaluation and Research (“CDER”) launched its latest publication, the “Drug Safety Newsletter”. This quarterly electronic publication is intended as an additional source of drug safety information for healthcare professionals and complements existing communications targeted at healthcare professionals …
On September 24, 2007, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking that would expand the classification of dronabinol, commonly known as delta-9-tetrahyrdocannabinol (“THC”), as a Schedule III controlled substance under the Controlled Substances Act. THC is a federally-controlled Schedule I controlled …
On September 28, 2007, the Washington Legal Foundation (“WLF”) asked the Supreme Court to review the U.S. Court of Appeals for the District of Columbia Circuit’s recent ruling in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach concerning access to experimental therapies. …
Earlier today, FDA announced that the Agency plans to take enforcement action with respect to marketed unapproved drugs containing hydrocodone. Hydrocodone is an opioid derived from codeine that is recognized both for its analgesic and antitussive effects, and is an active ingredient in several FDA-approved …
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 …
