FDA gave us all a New Year’s present on January 2nd when it announced the Agency’s new Data Dashboard. The Dashboard graphically breaks down data on FDA Inspections, Compliance Actions (warning letters, injunctions, and seizures – more commonly known by industry as “enforcement actions”), Recalls, …
Federal law continues to prohibit the possession, cultivation or distribution of marijuana and prohibits operating a business for these purposes. A number of states continue to follow Federal law and prohibit the use of marijuana under any circumstance, but a growing majority of other states …
On December 20, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) published a report entitled “Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates.” This report is the result of Congress’ September 2016 …
The U.S. Court of Appeals for the Second Circuit issued a decision a couple of weeks ago reversing the conspiracy conviction of a defendant for distribution of unapproved drugs, among other things. The trial court had rejected evidence relating to an advice-of-counsel defense asserted by the …
Sherman, set the Way-Back Machine. A press release from the U.S. Department of Justice announced that the former Compliance Director of Pharmakon Pharmaceuticals, Inc. has pleaded guilty in Indiana to conspiring to defraud the United States government by lying about failed potency tests of drugs that …
The Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation, and Compliance Conference is just a few weeks away, and spaces are going fast! The two-day conference will be held on December 6-7, 2017, in Washington, D.C. Hear from new government officials, including Rebecca Wood, the …
Back in the day, there were some freaky-looking cosmetic contact lenses that could make people look like they had the eyes of a wolf, a fish, or an insomniac vampire (excuse the redundancy, please). The costume accessories were especially popular with the frightener, if not …
The Sixth Circuit recently dealt another blow to relators seeking damages under the False Claims Act (FCA) based on allegations of off-label promotion. In a 2-1 decision, the court, in United States ex rel. Ibanez v. Bristol-Myers Squibb Co., affirmed the district court’s dismissal of …
Paul Simon sang about the 50 ways to leave your lover but there are more ways to go to jail if you are regulated by FDA. Congress has increased the regulatory powers of FDA significantly in the past 20 years but largely unnoticed has been …
It is the False Claims Act (FCA) case that wouldn’t die. The complaint in United States ex rel. King v. Solvay Pharmaceuticals, Inc. was originally filed in 2006 in the U.S. District Court for the Southern District of Texas. Through a series of partial summary …
On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning …
In a settlement noteworthy to any company with a drug subject to a Risk Evaluation and Mitigation Strategy (“REMS”), on September 5, 2017, the U.S. announced a multi-million dollar civil settlement with Novo Nordisk for an alleged violation of REMS requirements for its drug Victoza …
Since the Supreme Court issued its False Claims Act (“FCA”) ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016) courts have grappled with Escobar’s concept of FCA “materiality.” Materiality was described by the Supreme Court as a “rigorous” …
In an advisory opinion posted on August 25, 2017, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that enforcement action would not be taken against a drug manufacturer’s proposal to replace products that require specialized handling that …
According to a European Medicines Agency (EMA) press release issued on August 23, 2017, the FDA, the European Commission (EC), and the European Medicines Agency (EMA) recently signed a new confidentiality commitment that allows the FDA to share non-public and commercially confidential information, including trade …
