Bass, Berry & Sims attorneys John Kelly and Rob Platt authored an article in Life Science Compliance Update outlining risk areas faced by pharmaceutical and medical device manufacturers related to False Claims Act (FCA) violations. According to Department of Justice data, these manufacturers accounted for nearly half of FCA recoveries within the healthcare industry in 2016. As John and Rob discuss, last year's enforcement targeted several key risk areas, including speaker programs and off-label promotions, discount pricing programs, and violations of current good manufacturing practices (cGMP).
As the authors point out in conclusion, "the breadth of conduct that can expose manufacturers to unwanted liability is likely to expand as agencies and whistleblowers seek new ways to hold companies accountable for alleged misconduct. With that in mind, it is critical that pharmaceutical and medical device manufacturers develop adequate compliance programs that both help them prevent inappropriate conduct and allow them to address concerns if they arise rapidly."
The full article, "Pharmaceutical and Device Manufacturers: Buyer Seller Beware," was published in the July 2017 issue of Life Science Compliance Update and is available online to subscribers.