On April 18, the Supreme Court will hear oral argument in two consolidated cases that present the question of whether a defendant can “knowingly” submit a false claim under the Federal False Claims Act when the alleged falsity is based on an objectively reasonable legal …
The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the …
GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal …
A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification. …
(Caution: Links in the first paragraph are a wild musical ride. Click at your own risk) For those of you that review Rx ad/promo materials, it’s a familiar scenario: Marketing has come to the Legal Department with significant concerns about competitor activities – consumers are being …
As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge …
Sentencing for defendants convicted in federal court of felony offenses that involve fraud, including violations of the Federal Food, Drug, and Cosmetic Act, may be dramatically reduced based on an opinion issued last week by a panel of the Third Circuit Court of Appeals. The …
Anne Walsh of Hyman, Phelps & McNamara PC will be presenting on “The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they Conflict” as part of the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December …
Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” In particular, we noted …
The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number …
On October 6, President Joe Biden issued a brief but sweeping three-step statement towards reforming Federal marijuana law. The president’s first step was a pardon of all prior federal offenses of simple marijuana possession and a direction to the Attorney General to develop an administrative …
On September 26, 2022, Biogen Inc. agreed to pay $900 million to the United States and various states to settle a False Claims Act (FCA) lawsuit. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in …
In a recent JAMA editorial (unfortunately behind a paywall), three authors called for increased use of the Park Responsible Corporate Officer doctrine, under which senior level officials at a company can be held liable under a strict liability theory even if they were not involved …
In a speech last week, Deputy Attorney General Lisa Monaco touched on a number of topics that should interest readers of this blog. First, although the topic of her speech was corporate criminal enforcement, DAG Monaco stressed that DOJ’s “number one priority is individual accountability.” …
Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the …
