As Prescribed

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.

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA) recently issued three guidance documents that impacted the clinical trial landscape and established a new hub for clinical trial innovation.

Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)).

Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform Technology Designation Program. Section 506K was established by Section 2503 of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act of 2022 and enacted as part of the 2023 Consolidated Appropriations Act.

The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin. In 2024, these quotas grew to 20,000 g and 24,000 g, respectively, from just 30 g and 50 g in 2020.

Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). Since the original guidance was published in 2006, the agency has noticed an uptick in not only DMC usage but also broader DMC functions. As DMC use has changed, the guidance provides detailed considerations for sponsors regarding a variety of areas, including when a DMC may be appropriate, the scope of DMC responsibilities, and how to properly set up a DMC.

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug or biologic, as another chapter in its evolution toward the use of real-world evidence (RWE).

It is hard to believe that we are already in February and it has been a month since the 42nd Annual JP Morgan Healthcare Conference in San Francisco wrapped. It was a packed four days in which the major players in the life sciences industry gathered to make deals, form relationships, and discuss upcoming trends for the pharmaceutical and biotechnology industry.

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.

The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare partners Jacqueline Berman, Rebecca Dandeker, Maarika Kimbrell, and Kathleen Sanzo have assembled an in-depth report on drug and biologic developments at the FDA.