By Carmelina G. Allis – The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form FDA-483s before the agency’s issuance of Warning Letters. This announcement is in line with our …
By Douglas B. Farquhar – In an August 6, 2009 speech at an event sponsored by the Food and Drug Law Institute, Margaret A. Hamburg, M.D., the new FDA Commissioner, promised to ratchet up enforcement by speeding up issuance of Warning Letters, reducing the amount of time that …
By Carmelina G. Allis – We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code. The defendants allegedly conducted clinical …
Hyman, Phelps & McNamara’s John R. Fleder has written an article in the July/August 2009 edition of the Food and Drug Law Institute’s Update Magazine. The article is entitled: “Vindicated on Appeal – It Does Happen.” The article discusses a recent ruling in United States …
By Ricardo Carvajal – In a complaint filed on July 1, the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the …
By Carmelina G. Allis – We previously reported that the State of New Jersey had entered into an agreement with Synthes, Inc. to settle allegations that the company failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Now, …
JP Ellison – The U.S. Attorney's Office for the Western District of Missouri announced three guilty pleas to misdemeanor violations of the FDC Act in connection with the "nationwide recall of pet food and the death and serious illness of countless pets across the United States …
By Jamie K. Wolszon – Earlier this month, a U.S. District Court for the Northern District of California judge refused to dismiss a criminal indictment of the former Chief Executive Officer (“CEO”) of InterMune for misbranding and wire fraud charges connected to the off-label promotion …
The thought of federal agents storming the offices of an FDA-regulated company may seem far-fetched to some, but it is becoming a common reality, according to Hyman, Phelps & McNamara, P.C. attorneys John R. Fleder and William T. Koustas in a recent article in FDLI's Update publication. …
By JP Ellison – Today Attorney General Eric Holder and HHS Secretary Kathleen Sebelius announced the creation of a new interagency effort, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat healthcare fraud. Medicare appears to be the primary focus of the …
By JP Ellison – On May 18, 2009 the U.S. Department of Justice and sixteen states announced that they had intervened in whistleblower (qui tam) lawsuits pending in federal district court in Massachusetts against drug manufacturer Wyeth, alleging false claims act violations under federal and …
By Wes Siegner & Ricardo Carvajal – FDA has issued a warning letter to General Mills in which the agency alleges “serious violations” of the FDC Act in the label and labeling of Cheerios cereal. Specifically, FDA contends that the following label claims make Cheerios …
By Ricardo Carvajal – On May 11, FDA announced the condemnation and forfeiture of $1.3 million worth of dietary supplements marketed to body builders because the supplements contain “one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to …
By Christine P. Bump – The State of New Jersey announced this week that it had entered into a landmark agreement with Synthes, Inc. to settle allegations that Synthes failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Synthes …
By Ricardo Carvajal – At its public meeting on economically motivated adulteration ("EMA"), FDA got no shortage of suggestions on how to better prevent, detect, and address instances of EMA. FDA called the meeting “to stimulate and focus discussion about ways in which the food …
