Daniel C. Fundakowski

Leading life sciences and health care companies look to attorney Dan Fundakowski for strategic, practical advice in connection with health regulatory matters and related disputes.

Dan’s services include:

• Counseling clients on day-to-day health regulatory and compliance issues, including those implicating the federal False Claims Act (FCA); the federal Anti-Kickback Statute (AKS); the Food, Drug, and Cosmetic Act; the Physician Payments Sunshine Act; the HIPAA Privacy Rule; federal regulations governing human subjects research; state drug marketing and compliance laws; and state drug pricing transparency laws

• Guiding clients through government investigations stemming from allegations of the health care fraud and abuse laws and the federal FCA

• Advising clients on regulatory strategy related to drug and biological clinical and nonclinical development programs

• Assisting clients with creating and implementing compliance programs, and negotiating Corporate Integrity Agreements

• Counseling clients in connection with diligence matters and regulatory filings for affiliations, mergers and acquisitions, and other transactions

• Advising clients on how to prepare for and respond to inquiries and audits conducted by the federal government, state attorneys general, and government contractors

• Assisting clients with licensure and complex disputes with regulatory authorities, including the U.S. Department of Justice, the U.S. Food and Drug Administration, and state attorneys general

• Defending health care clients in disputes that are predicated on allegations of off-label promotion, violations of the AKS, research cost mischarging, and the improper reporting of usual and customary prices, among other regulatory allegations

• Conducting confidential internal investigations and audits concerning health care compliance and reimbursement matters, and assisting clients with self-disclosures

Read more

Academic and Professional Background

In a joint degree program, Dan received his J.D., with a Health Law Certificate, from Saint Louis University School of Law and his M.H.A. from Saint Louis University School of Public Health. During that time, he served on the Editorial Board of the Saint Louis University Law Journal.

While attending law school, Dan clerked in the U.S. Attorney's Office in the Eastern District of Missouri, where he worked on health care fraud and abuse investigations. He also interned at Cleveland, Ohio’s largest multispecialty academic medical center, and at a nonprofit provider of continuing care communities for seniors.

Additionally, during law school, Dan spent a semester in Washington, DC, clerking full time for the Health Care Division of the Federal Trade Commission, Bureau of Competition. In this capacity, he assisted with antitrust and competition law investigations and related proceedings within the health care sector.

After graduating from law school, Dan joined Epstein Becker Green in its Health Care and Life Sciences practice. He later served as an attorney in the Life Sciences Health Industry Group of a global law firm. In the fall of 2020, Dan returned to Epstein Becker Green.

Dan regularly writes and speaks on health care enforcement trends and developments. He is a recipient of the 2016 Burton Award for Distinguished Legal Writing for his work on the criminalization of health care noncompliance.

A native of Saint Louis, Missouri, Dan enjoys distance running, fishing, and following major league baseball.

Read less

• The Best Lawyers in America^©: “Ones to Watch” in Health Care Law (2024, 2025).

Education

• Saint Louis University School of Law (J.D., 2012)
  • Editorial Board, Saint Louis University Law Journal
  • Health Law Certificate – Center for Health Law Studies
• Saint Louis University (M.H.A., 2012)
  • School of Public Health
• Butler University (B.A., 2008)
  • Philosophy, Business Administration, Classical Studies

Professional & Community Involvement

• American Bar Association, Health Law Section
• American Health Lawyers Association