FDA Under President Trump Seeks to Abandon Expert Reviews of New Drugs

What's Happening?

The FDA, under the leadership of President Trump, is moving to discontinue the practice of convening outside expert panels to review drug applications. This shift marks a departure from a policy established in 1972, which aimed to incorporate expert advice in technical decisions regarding drug approvals. George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research, stated that these advisory meetings are redundant and consume significant resources. The FDA has traditionally aligned its actions with the votes of these committees, which have been instrumental in reviewing evidence and providing recommendations on drug approvals. The agency has begun publishing 'complete response letters' to companies when products are not approved, promoting transparency similar to that of advisory meetings.

Why It's Important?

The decision to abandon expert reviews could have significant implications for drug approval processes in the U.S. Critics argue that this move may reduce public scrutiny and transparency, potentially affecting the credibility of FDA decisions. Advisory committees have historically played a crucial role in ensuring rigorous evaluation of drug risks and benefits, providing a platform for public understanding and expert input. The change could consolidate decision-making power within the FDA, reducing accountability to external experts and the public. This shift may impact pharmaceutical companies, healthcare providers, and patients who rely on the thorough vetting of new drugs.

What's Next?

The FDA plans to continue consulting advisory committees on broader regulatory issues but will limit meetings on specific drugs. The agency will release complete response letters as they are issued, aiming to maintain transparency. The reduction in advisory meetings has already begun, with only seven held since President Trump reentered the White House, compared to 22 in the previous year. The FDA's approach may face opposition from former officials, academics, and industry stakeholders who value the input of advisory committees in the drug review process.

Beyond the Headlines

The move to abandon expert reviews may reflect a strategic consolidation of power within the FDA, potentially reducing accountability to outside experts and the public. This decision could lead to long-term shifts in how drug approvals are perceived and conducted, affecting the balance between industry pressures and rigorous scientific evaluation. The ethical implications of reducing public and expert involvement in drug approval processes may provoke debate among policymakers and healthcare advocates.