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Updates to FCPA and Impact for Healthcare Companies

By Lindsey Fetzer & Thad McBride on June 5, 2023
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We co-authored an article for Compliance Today with Channing Landreth, the associate vice president and managing counsel at Labcorp, to summarize how recent developments related to the Foreign Corrupt Practices Act (FCPA) impact healthcare companies.

As we point out, “Given its regulatory burden, the healthcare industry—including pharmaceutical, medical device, and biotechnology companies—is particularly vulnerable to FCPA issues.”

The article focuses on several specific FCPA issues for healthcare companies to consider, including: permissible domestic practices that could run counter to the FCPA, the broad definition of “foreign official,” third-party liability, and risks related to regulatory approvals.

Noting these challenges, we emphasize the importance of implementing a robust compliance program that includes two key elements in particular:

  1. Management involvement and support so the compliance message is strong and consistent from the very top.
  2. Implementation of a tailored compliance program based on the “prerequisite step of assessing risk so that compliance measures appropriately address those risks.”

To read more about the challenges faced by healthcare companies under the FCPA, please access the full article, “Update on the Foreign Corrupt Practices Act: Considerations for Healthcare Companies,” which was published in the June 2023 issue of Compliance Today and is available online.

Photo of Lindsey Fetzer Lindsey Fetzer

Lindsey Fetzer, a member in the Washington, D.C. office, represents clients in connection with government and internal investigations and litigations involving alleged violations of the False Claims Act (FCA), Anti-Kickback Statute (AKS), Foreign Corrupt Practice Act (FCPA), and other criminal and civil regulations.

Lindsey Fetzer, a member in the Washington, D.C. office, represents clients in connection with government and internal investigations and litigations involving alleged violations of the False Claims Act (FCA), Anti-Kickback Statute (AKS), Foreign Corrupt Practice Act (FCPA), and other criminal and civil regulations. Lindsey has represented clients in foreign and domestic matters involving the U.S. Department of Justice (DOJ), U.S. Securities and Exchange Commission (SEC), and other primary enforcement agencies.

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Photo of Thad McBride Thad McBride

Thad McBride advises public and private companies on the legal considerations essential to successful business operations in a global marketplace. He focuses his practice on counseling clients on compliance with U.S. export regulations (ITAR and EAR), economic sanctions and embargoes, import controls (CBP)…

Thad McBride advises public and private companies on the legal considerations essential to successful business operations in a global marketplace. He focuses his practice on counseling clients on compliance with U.S. export regulations (ITAR and EAR), economic sanctions and embargoes, import controls (CBP), and the Foreign Corrupt Practices Act (FCPA). He also advises clients on anti-boycott controls, and assists companies with matters involving the Committee on Foreign Investment in the United States (CFIUS). Thad supports international companies across a range of industries, including aviation, automotive, defense, energy, financial services, manufacturing, medical devices, oilfield services, professional services, research and development, retail, and technology. Beyond advising on day-to-day compliance matters, Thad regularly assists clients in investigations and enforcement actions brought by government agencies, including the U.S. Department of Justice (DOJ), the U.S. Treasury Department Office of Foreign Assets Control (OFAC), the U.S. State Department Directorate of Defense Trade Controls (DDTC), Customs and Border Protection (CBP), the U.S. Commerce Department Bureau of Industry & Security (BIS), and the Securities & Exchange Commission.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    GovCon & Trade
  • Organization:
    Bass, Berry & Sims PLC
  • Article: View Original Source

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