Maya Florence represents pharmaceutical, biotechnology and medical device manufacturers in Food and Drug Administration (FDA) enforcement and regulatory matters, federal and state government civil and criminal investigations, and litigation.

Bio

Ms. Florence has extensive experience in matters involving advertising and promotion issues, GMP/QSR compliance, fraud and abuse enforcement, federal and state anti-kickback laws, HIPAA and False Claims Act defense. Her work often involves assisting clients in balancing the competing demands and navigating risks involved in concurrent investigations by federal authorities and state attorneys general.

Ms. Florence also frequently provides legal and strategic advice to FDA-regulated companies, as well as hospitals and other health care providers, regarding fraud and abuse and compliance in several contexts, including FDA regulatory compliance, Corporate Integrity Agreement implementation, internal investigations and strategic transactions. She has significant experience developing, implementing and assessing corporate compliance programs for pharmaceutical and medical device companies. In addition, Ms. Florence frequently conducts due diligence and strategic counseling in connection with life sciences and health care industry transactions, and has advised clients on more than 150 transactional matters.

Ms. Florence’s recent representations include:

  • two pharmaceutical manufacturers in concurrent criminal and civil investigations by the U.S. Department of Justice (DOJ) and numerous state attorneys general relating to the marketing of opioid medications, as well as general FDA regulatory issues, health economics and proactive health care compliance matters;
  • Biogen, Inc. in the defense of multiple consolidated qui tam suits brought under the federal False Claims Act in the District of Massachusetts;
  • a major medical product trade organization in drafting comments for submission to two FDA dockets;
  • Becton, Dickinson and Company in its $24 billion acquisition of C. R. Bard, Inc.;
  • Veloxis Pharmaceuticals A/S as plaintiffs in filing a federal action against the FDA to reverse the agency’s decision to delay approval of Veloxis’ new drug Envarsus XR based on marketing exclusivity given to an earlier-approved competing drug;
  • a leading biotechnology company on FDA, health care and global regulatory compliance matters in connection with several acquisitions and strategic commercial transactions;
  • a major medical device manufacturer in providing strategic regulatory and compliance advice in connection with the company’s marketed products, and in connection with a DOJ investigation;
  • a leading pharmaceutical company in connection with emerging developments relating to the marketing of prescription medications, general FDA regulatory and health care compliance matters, and in conducting internal investigations of regulatory and compliance matters;
  • Humana Inc. in its contemplated merger with Aetna for $37 billion in cash and stock; and   
  • multiple pharmaceutical and medical device manufacturers in providing strategic counseling regarding reimbursement and patient support services.

Ms. Florence has repeatedly been selected for inclusion in Chambers USA: America’s Leading Lawyers for Business. In addition to her practice, Ms. Florence is a member of the firm’s Women’s Initiative Committee, which works to promote the retention and advancement of women in the firm.

Selected Presentations

  • “Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar,” Skadden, Palo Alto, CA, March 29, 2018
  • “American Conference Institute FDA Boot Camp, Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls,” New York, March 9, 2018
  • “Managing Risk in the Whistleblower Nation,” Health Care Law & Compliance Institute, Dallas, March 5, 2018
  • “A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar,” Skadden Seminar, November 14, 2017
  • “False Claims Act Developments: What to Consider When the Government Declines Intervention,” Skadden Webinar, November 14, 2017

Credentials

Education

  • J.D., Harvard Law School, 2004 (cum laude)
  • B.A., University of Pennsylvania, 2001 (summa cum laude)

Admissions

  • Massachusetts
  • New York
  • District of Columbia

Experience

  • Law Clerk, Hon. Colleen Kollar-Kotelly, U.S. District Court for the District of Columbia (2006-2008)

Maya P. Florence

Partner, Health Care and Life Sciences
maya.florence@skadden.com