60 Minutes on Legislation, Politics and Policy

The Future of FCA Enforcement Under the Biden Administration: Compliance Strategies for Life Sciences & Healthcare

September 24, 2021 10:30am

David N. Kelley
Dechert LLP

Gregg Shapiro
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
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