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. …
Earlier this week, the European Medicines Agency (“EMEA”) announced that EMEA and FDA have adopted a common application form for sponsors seeking orphan drug designation in the European Union (“EU”) and the U.S. The move to a common application form was anticipated when FDA and …
On November 20, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to remove the thresholds for distributing, importing, and exporting pseudoephedrine and phenylpropanolamine (“PPA”). In September 2007, DEA indicated in testimony before the Senate Finance Committee that the Agency was in the process …
In the preemption world, “fraud on the FDA” cases are fairly common. As one court recently used the term, fraud on the FDA means a drug or a medical device company is liable to someone who was injured by their product if that product was …
The Deficit Reduction Act of 2005 changed the basis for the federal government’s calculation of how much it reimburses states for their Medicaid generic prescription drug purchases. Instead of using the “average wholesale price,” or AWP, which is a benchmark price, the federal reimbursement is …
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). …
Late last week, FDA announced several steps intended to strengthen the advisory committee process. The announced improvements are part of a broader FDA effort to address recommendations made by the Institute of Medicine in its September 2006 report, titled "The Future of Drug Safety: Promoting …
In early October, we reported on legislation introduced in the U.S. House intended to restrict the distribution and possession of raw dextromethorphan, an antitussive drug found in many over-the-counter cold/cough drug products. Dextromethorphan is not a federally-controlled substance, however, the Drug Enforcement Administration (“DEA”) recently …
Last week we reported that on October 24, 2007, Cobalt Pharmaceuticals Inc. (“Cobalt”) submitted to FDA an emergency petition for stay of action in which Cobalt publicly disclosed the company’s status as a first applicant eligible for 180-day exclusivity for generic acarbose tablets — marketed …
Earlier this year, President Bush signed Executive Order 13439 establishing the Interagency Working Group on Import Safety (“Working Group”). The Working Group, chaired by Department of Health and Human Services Secretary Mike Leavitt, was charged with conducting a comprehensive review of current import safety practices …
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 …
Yesterday, Representatives Henry Waxman (D-CA) and Tom Allen (D-ME) and Senator Ted Kennedy (D-MA) announced plans to introduce the Non-Prescription Drug Modernization Act of 2007 (“NDMA”). The bill comes in the wake of recent concern over the use of Over-the-Counter (“OTC”) cough/cold drugs in children …
In September, we reported that FDA established a public docket (#2007N-0417) soliciting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning the diabetes drug acarbose (marketed by Bayer Pharmaceuticals under the tradename PRECOSE). Specifically, FDA’s September 26, 2007 letter states: As …
Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” (The …
