Debevoise combines a laser-like focus on client objectives, with deep transactional and litigation experience across a wide range of sectors in the healthcare & life sciences industry.
Andrew L. Bab
Mark P. Goodman
Maura Kathleen Monaghan
Kevin A. Rinker
Paul D. Rubin
They are incredibly detail-orientated and have a good sense of how to think about risk and understanding what kind of risks to take.
—Chambers USA, 2021
Ranked among the leading New York firms for Healthcare.
—Chambers USA, 2023
Debevoise FDA lawyers Paul D. Rubin and Melissa Runsten discuss OTC drug provisions in the CARES Act and explain how companies and investors can take advantage of the potential opportunities for innovation that exist under the new regulatory regime. View the webcast here.
The Debevoise Healthcare & Life Sciences Group employs a highly coordinated, multidisciplinary approach to address transactional, litigation and intellectual property matters for leading healthcare & life sciences companies and for private equity firms investing in the industry. The team provides integrated, cross practice legal advice with efficient and seamless execution covering all aspects of healthcare & life sciences matters, including corporate and M&A, litigation and compliance, FDA/FTC regulatory, intellectual property, including licensing and collaboration agreements, and cyber security & data privacy. This approach offers clients a “one-stop-shop” for healthcare and life sciences across nearly all subsectors and stages of the industry lifecycle. The practice’s lawyers are knowledgeable about the issues faced by companies operating and investing in the sector, which enables the Group to develop comprehensive and commercial strategies and solutions.
The Group draws from a broad array of practices throughout the firm, leveraging its experience in private equity, M&A, finance, capital markets, restructuring, litigation, government and regulatory investigations, tax, intellectual property and antitrust, among others. It is well versed in the increasingly global issues facing healthcare & life sciences clients and is well positioned to address those issues through the sophisticated capabilities of the firm’s offices around the world.
The team handles significant transactions and regulatory and litigation matters in a wide variety of areas for pharmaceutical companies, hospitals, medical device manufacturers, financial sponsors, financial advisors and other key players in the industry. The Group’s transactional work includes mergers and acquisitions, financings, securities offerings, licensing, development and commercialization transactions, while its litigation work spans investigations by U.S. government agencies, “bet-the-company” defense work, compliance with U.S. regulatory requirements and defense of intellectual property rights.
The changes contemplated by the Biden administration are sure to have significant implications for every sector of the healthcare & life sciences industry. We will be closely following these developments and providing you with the information you need to stay abreast of coming changes.
29 August 2023
California Regulators Publish Draft Regulations on Health Care Pre-Transaction Notice Requirements
Last year, the California Health Care Quality and Affordability Act (“SB 184”) established the Office of Health Care Affordability (“OHCA” or “the Office”), a new state health care cost commission tasked with, among other things, analyzing health care mergers, acquisitions, affiliations and other transactions involving regulated health care entities. OHCA recently released draft regulations to implement and clarify certain provisions of SB 184, including, among other things, the scope of regulated health care entities, the types of transactions that constitute a “material change” subject to notice requirements and applicable regulatory review periods. Although the Office does not have the authority to block or challenge health care transactions, if adopted in their current form, the Draft Regulations could nonetheless have an adverse effect on health care dealmaking in California, raising concerns over timing of transactions as well as potential costs. Read more. >
21 August 2023
California Seeks to Increase Healthcare Workers’ Minimum Wage to $25/hour
California is poised to pass Senate Bill 525 (“SB 525” or the “Bill”), which would raise the minimum wage for all workers in healthcare facilities across California to $25 per hour by June 1, 2025, and provide a private right of action for any covered worker to enforce the minimum wage requirement. While Senator María Elena Durazo (D), the primary author of SB 525, and proponents of the Bill argue that increasing wages would provide much needed benefits for healthcare workers which, in turn, would improve patient care quality, the Bill has been met with strong opposition from a wide range of interested stakeholders, including the California Hospital and California Children’s Hospital Associations, the California Medical Association, educational institutions, and numerous business organizations. Read more. >
31 July 2023
Artificial Intelligence in Healthcare: Balancing Risks and Rewards
The healthcare industry is rapidly adopting artificial intelligence (“AI”) with the understanding that AI has the power to revolutionize healthcare quality and delivery.Healthcare companies that utilize AI must monitor a complex and evolving framework of foreign and domestic enforcement agencies, as well as foreign, state and local laws and regulations, to fully appreciate the opportunities and risks that AI presents. The use of AI in healthcare also raises significant practical and ethical concerns, which will require healthcare companies to implement the right balance of control and oversight to increase transparency while still extracting the benefits that AI provides. Read more. >
30 May 2023
FDA Guidance Offers Additional Clarity for Decentralized Clinical Trials
On May 2, 2023, the Food and Drug Administration (“FDA”) released new draft guidance with recommendations to help entities conducting decentralized clinical trials (“DCTs”) to fulfill regulatory obligations. The draft guidance builds on previous draft guidances issued by FDA in 2020 to facilitate DCTs in response to the COVID-19 pandemic and in 2021 on the use of digital health technologies to collect data from clinical trial patients remotely. Read more. >
16 May 2023
Artificial Intelligence and the Life Sciences Industry: FDA and FTC Regulatory Update
The life sciences industry is embracing the use of artificial intelligence (“AI”) while the regulatory framework continues to evolve. Read more. >