60 Minutes on Legislation, Politics and Policy
The Future of FCA Enforcement Under the Biden Administration: Compliance Strategies for Life Sciences & Healthcare
David N. Kelley
Partner
Dechert LLP
Gregg Shapiro
Attorney
Newman & Shapiro
(Former Chief, Affirmative Civil Enforcement Unit, U.S. Attorney’s Office, District of Massachusetts)
Matthew Feeley
Assistant United States Attorney
Southern District of Florida
Courtney Gilligan Saleski
Partner
DLA Piper
- Analyzing the Biden Administration’s enforcement policies and priorities of FCA violations by life sciences and healthcare companies
- Anticipating and predicting trends in enforcement from DOJ and FDA
- Preparing for the increase in FCA violations related to FDA’s Good Manufacturing Practice requirements (cGMP)
- Reviewing state and federal investigations and prosecutions stemming from COVID-19 related fraud
- Evaluating fraudulent or unproven medical products
- Adapting to Medicare requirements announced by CMS
- Anticipating an increase in FCA violations related to FDA’s Good Manufacturing
- Preparing for the government’s interest in ensuring PE firms provide oversight of the acquisition of life sciences and healthcare corporations
- Analyzing the expanded reach of FCA enforcement efforts now including opioid marketers and pharmacies