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're always prepared, they always think creatively and their work product is excellent.
Ranked among the leading New York firms for Healthcare.
—Chambers USA, 2020
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.
Proposed Elimination of Medicaid Rebate Cap Could Negatively Impact Innovator Pharmaceutical Industry
Both houses of Congress are currently working on a “budget reconciliation” process that could ultimately lead to enactment of a bill that, among other things, would authorize $1.9 trillion in additional government spending. As part of this process, on February 9, 2021, the House Energy and Commerce Committee (“House E&C Committee”) announced it is considering the elimination of a cap on certain rebates pharmaceutical companies pay to the Medicaid program. Read more. >
Biden Takes Aim at Trump Administration Healthcare Policies
On January 28, 2021, marking a significant departure from the Trump Administration, President Biden issued an Executive Order with the stated purpose of strengthening the Affordable Care Act (“ACA”) and Medicaid. Read more. >
Consolidated Appropriations Act: Implications for Healthcare and Life Sciences Companies
On December 27, 2020, President Trump signed into law the Consolidated Appropriations Act (the “Act”), a massive coronavirus relief and spending bill. At over 5,000 pages, the Act provides funding for economic relief and public health measures to address the pandemic, and also includes regulatory provisions with significant implications for healthcare and life sciences companies. Read more. >
The Trump Administration’s Final Drug Pricing Hurrah—Will It Last?
On November 20, 2020, the Department of Health and Human Services (“HHS”) issued two sets of rules addressing longstanding Trump administration proposals intended to reduce prescription drug prices. HHS issued an Interim Final Rule that will result in “Most Favored Nation” (“MFN”) pricing for certain Medicare Part B drugs, effectively subjecting them to a form of price control. HHS also issued a Final Rule that would repeal the regulatory safe harbor under the Anti-Kickback Statute (“AKS”) for rebates from prescription drug manufacturers to pharmacy benefit managers (“PBMs”) that administer Medicare Part D plans. As described in greater detail below, both rules are highly controversial and may be subject to legal challenge. The Biden administration could also decide to repeal these initiatives. Read more. >
The Potential Impact of a Biden Administration on Life Sciences, Healthcare, and Consumer Product Companies and Investors
With Election Day tomorrow and the possibility of new President sworn in on January 20, 2021, in this article we highlight the potential implications of a Biden
Administration on life sciences, healthcare, and consumer product companies and investors. Specifically, we explore potential Biden Administration policy changes that may impact these important sectors of the economy, taking into consideration a variety of factors including Congressional control, composition of the President’s cabinet, the administration’s policy priorities, and outside factors such as the coronavirus pandemic and economy. Read more. >