For the first time in over a decade, the United States Sentencing Commission (the “Commission”) is considering amending the Sentencing Guidelines that are applied to individuals and organizations convicted of criminal violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 72 Fed. Reg. …
We have seen a rash of cases brought by the government and private “whistleblowers” alleging that companies have violated the Federal False Claims Act (“FCA”) by promoting the sales of drugs and devices for “off-label” uses (i.e., uses that have not been approved by FDA). …
The U.S. Court of Appeals for the Seventh Circuit, in its recent opinion in United States v. Global Distributors, Inc., remanded for reconsideration to the U.S. District Court for the Northern District of Illinois (Eastern Division) the imposition of the maximum allowable monetary penalties under …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
In two previous posts (here and here), we reported on a trend in Warning Letters issued by FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) that focuses on ensuring that promotional pieces contain substantial evidence to support advertising claims and proper presentations of safety …
Last Friday, FDA announced the Agency’s plans to take enforcement action against firms marketing unapproved drug products in timed-release dosage forms containing guaifenesin, a commonly used expectorant drug. On May 29, 2007, FDA published a Federal Register notice to this effect. FDA’s latest action is …
Our colleague John Fleder has just written an article for FDLI Update that outlines the agencies and offices that get involved in decisions to commence FDA enforcement actions, such as Warning Letters, seizures, injunctions (consent decrees), and criminal prosecutions. Mr. Fleder, who used be the …
As we previously reported, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) has, in the past year, focused its efforts on ensuring that promotional pieces contain proper presentations of safety data and appropriate efficacy claims. Two new Untitled Letters from DDMAC, however, illustrate that …
As we previously reported, FDA has promised to accelerate its enforcement efforts against marketed unapproved drugs in 2007. Indeed, in the past month, FDA has announced two enforcement actions, and future actions are likely. In early April 2007, FDA announced that companies must stop manufacturing and …
