As Prescribed

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.

On the last day of the 2024 J.P. Morgan Healthcare Conference, we’re taking a look back at the last year to revisit the developments that had a considerable impact on the life sciences industry, including the transactional market.

With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration (FDA), recently issued a policy statement describing how the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits “unfair methods of competition.”

As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program.

At a recent Food and Drug Law Institute (FDLI) conference, Arun Rao, Deputy Assistant Attorney General for the US Department of Justice’s (DOJ’s) Consumer Protection Branch (CPB), reiterated DOJ’s “Safe Harbor Policy” with respect to mergers and acquisitions (M&A). Mr. Rao’s comments demonstrate DOJ’s continued efforts to promote its corporate compliance and self-disclosure initiative, which continues to create important implications for stakeholders in the life sciences industry.

FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on November 22, which follows a proposed rule on the same topic published in 2010.

Substantial evidence, the evidentiary standard for effectiveness established in 1962 by the US Federal Food, Drug, and Cosmetic Act (FD&C Act), is the measure against which all drugs and biologics are approved in the United States. This standard is, in large part, what makes the FDA’s approval standard often considered the worldwide “gold standard” for drug approvals. Now, recent draft guidance issued by FDA looks to refine this standard even further.

FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant growth, and plans to address challenging scientific and regulatory issues. With a well-earned reputation of stability, and slow, plodding progress, moments with so many elements in flux at FDA don’t come around often, so it is worth keeping an eye on how these begin to unfold to have a sense of where CBER—central to many of the exciting developments in industry—is headed.

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition.