Ms. Florence has counseled on matters involving fraud and abuse enforcement, federal and state anti-kickback laws, advertising and promotion issues, GMP/QSR compliance, artificial intelligence and cybersecurity, 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 300 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
- 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 multinational medical device manufacturer in an internal investigation of potential fraud and abuse in connection with a patient support program, including counseling regarding potential self-disclosure mechanisms
- 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
- 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
- POINT Biopharma in its $1.4 billion sale to Eli Lilly
- Intercept Pharmaceuticals in its $800 million sale to Alfasigma
- Mayne Pharma Group Limited in its $475 million sale of Metrics Contracts Services to Catalent, Inc.
- Alnylam Pharmaceuticals, Inc. in its $2.8 billion co-development and co-commercialization agreement with Roche Holding AG to develop and commercialize its hypertension drug Zilebesiran
- 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 selected for inclusion repeatedly 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.