As Prescribed

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community.

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As the sector navigates a dynamic landscape of scientific advancements, economic pressures, and regulatory changes, stakeholders are increasingly leveraging strategic transactions to gain a competitive edge.

As the healthcare and life sciences industry gears up for the highly anticipated JP Morgan Healthcare Conference later this month, stakeholders across the sector are focusing on key trends and strategies to make the most of this unparalleled networking and deal-making event. To help attendees make the most of the 2025 conference and related events, Morgan Lewis recently hosted its second annual Pre-JPM Conference Networking Event featuring a panel discussion of industry leaders, who offered insights into what they are prioritizing in the run-up to the conference and how they are positioning themselves for a successful conference.

340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies, manufacturer restrictions on contract pharmacies and 340B distribution, CE data submission requirements, and the definition of “patient.” With billions of dollars at stake, it is unlikely that manufacturers or CEs will change course any time soon. And while federal and state legislation has been proposed to address these issues, we cannot know whether such legislation will be enacted.

The US Supreme Court recently debated the future of the legal precedent known as Chevron deference in two separate cases arising out of the National Marine Fisheries Service’s statutory interpretation of the Magnuson-Stevens Act, a statute it enforces. The decision in these cases will almost certainly have far-reaching impacts on agency actions, including as it is applied in the healthcare and life sciences industries.

Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations. Many companies working on COVID-19 products, services, and treatments are not traditional healthcare or life sciences companies. This, however, is a highly regulated space, and regulators are continually issuing new policies and regulations. As companies lend their expertise to the battle against the pandemic, they should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability risks.