Under Trump, FDA seeks to abandon expert reviews of new drugs

The FDA, under President Trump, is moving to abandon its long-standing practice of using external advisory committees to review individual drug applications, a shift advocated by George Tidmarsh, head of the Center for Drug Evaluation and Research. Tidmarsh contends these panels are redundant and resource-intensive, asserting that transparency can be achieved through the publication of complete response letters. However, critics, including former FDA officials and academics, warn this change will reduce crucial expert input and public scrutiny, potentially undermining the rigor and public trust in drug approval decisions, citing past controversies such as the Aduhelm approval.

Analysis

The Food and Drug Administration (FDA) is signaling a significant shift in its drug approval process, intending to phase out the use of external advisory committees for individual drug applications. George Tidmarsh, a key FDA leader, publicly stated the agency's desire to abandon these expert panels, framing them as redundant and resource-intensive. The proposed alternative for maintaining transparency is the recent initiative to publish complete response letters (CRLs) sent to companies upon drug application rejection. This policy change is already manifesting, with a sharp decline in advisory meetings from 22 in the prior year's period to just seven this year. However, this move is met with substantial criticism from former FDA officials and academics, who argue it removes a vital layer of public scrutiny and independent expert validation. The controversy surrounding Biogen's Aduhelm approval, where the FDA greenlit the drug despite a negative committee vote, is cited as a prime example of the tensions this new policy could exacerbate. The direct impact is already apparent for companies like Capricor Therapeutics, which saw its planned advisory meeting canceled before receiving a CRL. Critics contend that this shift away from public expert deliberation, which historically aligns with FDA decisions 97% of the time on 'yes' votes, could lead to a less transparent, more politicized, and potentially less rigorous approval process, thereby consolidating power within the agency and increasing regulatory uncertainty for the entire pharmaceutical and biotech industry.

Key Decisions for Investors

• Investors in the biotech sector should heighten their assessment of regulatory risk, as the removal of advisory committees introduces significant unpredictability into the approval pathway, especially for companies with novel or controversial drug candidates.
• Pay close attention to small and mid-cap biotechs, such as Capricor Therapeutics, which are particularly vulnerable as they lose a public forum to validate their science and now face a more opaque, internal FDA review process.
• The newly published Complete Response Letters (CRLs) will become a critical data source; investors should meticulously analyze these documents to retrospectively understand the FDA's evolving decision-making criteria in the absence of pre-decisional committee debates.