Eye on FDA

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high interest to patients, clinical communities, industry stakeholders and policy-makers in Congress.

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022 petition filed by the Center for Science in the Public Interest, among other food safety and health advocates, which asserted that the additive induces cancer in male rats and urged the agency to revoke authorization. 

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight. Notably, this draft guidance includes recommendations with respect to the clinical assessment of weight reduction drugs in both adults and pediatric patients, revising and replacing the draft guidance for industry “Developing Products for Weight Management” issued in February 2007. 

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated Appropriations Act, 2023, Congress gave the FDA the authority to require that a confirmatory trial be underway prior to the granting of accelerated approval or within a specific time period after the date of accelerated approval. This latest guidance comes on the heels of the accelerated approval guidance issued by the agency just last month (see prior analysis here), in which the agency stated its intent to address the 2023 authority in a separate guidance.

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and rules, and might ultimately have different policy priorities and goals than the previous administration. Thus, the release of these numerous new guidances reflects topics that the FDA likely views as particularly important to address.

In recent days, President-elect Trump has made progress in announcing the names of various individuals he intends to nominate to serve in some of the most senior and influential leadership positions at the Department of Health and Human Services (HHS) and which also require Senate confirmation. The first of these announcements was that President-elect Trump intends to nominate RFK Jr. to serve as HHS Secretary. The HHS Secretary is responsible for overseeing all 13 of the Department’s Operating Divisions, including the FDA, in addition to the Department’s staff divisions. President-elect Trump also recently announced his intent to nominate physician and former Representative Dave Weldon (R-FL) to serve as the next Director of the Centers for Disease Control and Prevention and Dr. Janette Nesheiwat as the next Surgeon General.