Biden Is Late to Name an FDA Commissioner
(Bloomberg Opinion) -- Five months into Joe Biden’s presidency, the Food and Drug Administration is without a leader. This is too long for a critical health agency to wait as the country works to fully emerge from a pandemic. And that’s not the only reason for urgency.
Under an acting commissioner, the FDA isn’t paralyzed. It can go about its business of reviewing drugs and medical devices. But it lacks a properly accountable leader to set its course, represent the agency to the public, and make sure its processes are working as they should.
Lately the agency has fallen short. It recently ignored its own scientific panel’s advice and approved aducanumab, an expensive but possibly ineffective Alzheimer’s treatment. The decision was based not on data showing that the drug works, but on indirect evidence that it might work because it acts on the amyloid plaques that might be a cause of Alzheimer’s dementia.
In recent years, and especially during Donald Trump’s administration, the FDA has come under pressure to speed up drug reviews and to make more medicines available for emergency use before they are even provisionally approved. The unorthodox approval of aducanumab, widely criticized by medical experts, suggests the FDA might be beginning to let down its traditional standards and countenance drugs that seem merely promising.
That would be a worrisome shift in direction. Doctors, patients, drugmakers and taxpayers are entitled to expect that medicines and medical devices will not be allowed onto the U.S. market if scientists cannot find sufficient evidence that they work — and that the agency’s judgment will not be influenced by political pressure. Biden’s nominee to be FDA commissioner should be asked, in Senate approval hearings, exactly what she or he will do to maintain high standards for drug quality.
Other urgent business before the FDA involves tobacco regulation. The agency has already announced a plan to ban the sale of menthol cigarettes; a new leader is needed to make sure the regulations are written and steered through the approval process without delay. The FDA should also extend the proposed menthol flavor ban to vaping products, limit nicotine levels in cigarettes and e-cigarettes, and continue to monitor and restrict teenagers’ access to tobacco. A permanent, accountable commissioner can make sure this work gets done.
Biden has taken longer than his predecessors to name an FDA head, and for months, former commissioners have implored him to move faster. Health and Human Services Secretary Xavier Becerra says the holdup is Biden’s special concern for the FDA job. “This is one of those positions where obviously the president is very interested because FDA is just not another agency, it’s a critical agency,” Becerra told Bloomberg Law.
Yes, it’s critical. That’s what makes the delay in appointing a leader so damaging.
Editorials are written by the Bloomberg Opinion editorial board.
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