DOJ has issued another “voluntary disclosure” policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition. Under this new policy, a company will receive a “presumption of declination” of agency action – i.e., a safe harbor – if …
As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. See some of our prior posts, here, here, and here. If committed with …
Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here). FDA now seeks comments on this very program to support its continued collection of information as …
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 …
Legal doctrines can be like parrots. Sometimes it is hard to know if they are dead or just resting. Under the False Claims Act (FCA), if a company’s fraudulent conduct induces a governmental entity to enter into a contract with the company, then any claims for …
All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field. But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates …
On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that …
It may be just a coincidence that DOJ released its latest policy pronouncement at the same time as the final “Daniel Craig as James Bond” movie. But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they …
The adage that “no one is perfect” applies as equally to companies as it does to people. Before committing to a merger or acquisition with another company, a potential Buyer must conduct due diligence to identify the imperfections of a target company so the Buyer …
Companies often use rebranding to reposition and refocus their business. Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally. The federal government does its own version of rebranding with each change in administration. Just before the July 4 holiday weekend, …
In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to …
On April 2, 2021, the Ninth Circuit issued a decision in a False Claims Act (FCA) case against Medtronic. The Dan Abrams Co. LLC v. Medtronic Inc., No. 19-56377, 2021 U.S. App. LEXIS 9637 (9th Cir. Apr. 2, 2021). Relator appealed the U.S. District Court …
It’s not just drug companies that push the limit on marketing their products – see our posts about recent OPDP warning letters. Medical device companies are fighting for any edge to differentiate their products too. Even before COVID-19 brought an onslaught of new players to …
It’s a burning question: when will we return to normal? And although the answer is hugely subjective, this post focuses on the date the official emergency declaration for COVID-19 will terminate. Despite the general sentiment that we want to be back to normal sooner rather …
Although it is difficult to glean much positive during these COVID-times, particularly if you are (or could be) the subject of a government enforcement action, this post attempts to provide a possible silver lining. As part of an effort to support economic recovery during this …
