Ms. Florence has counseled on matters involving fraud and abuse enforcement, federal and state anti-kickback laws, advertising and promotion issues, GMP/QSR compliance, HIPAA and False Claims Act defense, among other representations. She excels at advising clients facing complex challenges, quickly and efficiently assessing the wide spectrum of unique issues impacting life science and health care companies, and providing practical, business-minded advice.
Ms. Florence’s extensive experience across multiple matter types allows her to keep one step ahead of potential issues and proactively identify impact areas for clients in the industry. She applies this insight in advising FDA-regulated companies, genomic laboratories and other health care providers regarding fraud and abuse and FDA regulatory compliance in several contexts, including in connection with internal investigations, corporate integrity agreement implementation and corporate compliance programs assessments. In addition, Ms. Florence frequently serves as a subject-matter expert on high-stakes transactions, and has advised clients on more than 200 transactional matters.
Ms. Florence’s recent representations include:
- Purdue Pharma L.P. in connection with emerging developments relating to the marketing of opioid medications, including its successful resolution of U.S. Department of Justice (DOJ) civil and criminal investigations concerning the sale and marketing of opioid products;
- a pharmaceutical manufacturer in concurrent criminal and civil investigations by the DOJ and numerous state attorneys general relating to product marketing;
- a leading genomic laboratory in a self-disclosure of health care fraud and abuse concerns identified through an internal investigation, as well as the subsequent government investigation; and
- a rare disease biotechnology company in an internal investigation of allegations regarding improper product promotion, as well as strategic counseling regarding product promotion, reimbursement and patient support services, and medical affairs activities.
- a major medical product trade organization in drafting comments for submission to two FDA dockets;
- 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; and
- multiple pharmaceutical and medical device manufacturers in providing strategic counseling regarding marketing and promotion strategies, medical affairs activities, engagements with health care professionals, and reimbursement and patient support services.
- Dicerna Pharmaceuticals, Inc. in its $3.3 billion acquisition by Novo Nordisk;
- Permira, a private equity firm, in the sale of contract development and manufacturing company Lyophilization Services of New England, Inc., a company backed by the Permira funds;
- Alcon in its $355 million acquisition of the U.S. commercialization rights to the ophthalmic medication Simbrinza from Novartis;
- GX Acquisition Corp., a special purpose acquisition company sponsored by Trimaran Capital Partners, in its merger with Celularity Inc., a clinical-stage biotechnology company. The combined company is expected to have an initial post-transaction equity value of approximately $1.7 billion; and
- Honeywell in its $1.3 billion acquisition of Sparta Systems, a provider of enterprise quality management software for the life sciences industry, from New Mountain Capital and other stockholders.
Ms. Florence has been repeatedly selected for inclusion in Chambers USA: America’s Leading Lawyers for Business and was named a Go To Life Science/Health Care Lawyer in 2022 by Massachusetts Lawyers Weekly. In addition, she serves as the Boston office hiring partner and a member of the firm’s Women’s Initiatives Committee, which works to promote the retention and advancement of women in the firm.