As Prescribed

As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and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 Now, recent draft guidance issued by FDA looks to refine this standard even further.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.

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent protection for emerging biotech companies with patent agent Emily Coury.

Fundraising is one of the key activities in the lifecycle of an emerging company: many CEOs of emerging companies have stated that they are always in financing mode. Given the high cost of bringing life science products to market, raising funds is especially challenging in the biotechnology sector.

Today marks the kickoff of the Biotech Week Boston event series, and for the rest of the week our As Prescribed blog will feature posts exclusively from our Boston life sciences lawyers. Local partners Michael Barron, Laurie Burlingame, and Stephen Altieri will be blogging from the capital of the commonwealth, where they are expressly positioned to advise biotech companies at all phases of their lifecycles, as well as the entities that invest in them.

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.