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.
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;
- a major medical product trade organization in drafting comments for submission to two FDA dockets;
- Biogen, Inc. in the defense of multiple consolidated qui tam suits brought under the federal False Claims Act in the District of Massachusetts;
- 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;
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.
- J.D., Harvard Law School, 2004 (cum laude)
- B.A., University of Pennsylvania, 2001 (summa cum laude)
- New York
- District of Columbia
Rate : $$$