The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Gwen M. McKee and John R. Fleder discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). While the enforcement provisions of FDAAA have frequently been ignored in public …
The Food and Drug Law Institute is scheduled to hold its 6th Annual Conference on Enforcement and Litigation on February 19-20, 2008. Among other topics of discussion slated for the conference are the U.S. Sentencing Commission’s proposed guidelines that would greatly enhance the criminal penalties …
The United States Sentencing Commission (“Commission”), which sets the guidelines that are usually followed by federal judges sentencing defendants convicted of federal crimes, has issued proposed Sentencing Guidelines (“Guidelines”) that would likely greatly enhance the criminal penalties applied to some criminal violations of the Federal …
We previously reported on FDA’s plans to take enforcement action with respect to firms manufacturing and distributing unapproved drugs containing hydrocodone. According to the October 1, 2007 FDA Federal Register notice: Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than …
On December 21, 2007, the United States Attorney’s Office for the District of Massachusetts announced that pursuant to a plea agreement reached on October 30, 2007, under Federal Rule of Criminal Procedure 11(c)(1)(C), under which the parties can agree to the particular sentence imposed (subject …
Late last week, a yet-to-be released FDA draft guidance on “Good Reprint Practices” was made public by Rep. Henry Waxman (D-CA). Waxman, on behalf of the Committee on Oversight and Government Reform, issued a letter to FDA strongly urging it to refrain from finalizing and …
We previously reported that the Supreme Court had agreed to hear the PMA device preemption case Riegel v. Medtronic, Inc. The status of the case was in question earlier this fall because of an untimely motion to substitute the correct party (following the death of …
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 …
