But the flare-up over aducanumab shows not some flaw with FDA decision-making, but rather deeper issues with the agency’s overly broad mandate. The FDA should address these resignations by clarifying their mission and ensuring that vacancies don’t hobble the agency’s core functions. There’s no turning back now from a wiser, more flexible FDA that puts the needs of patients first.

Big decisions carry large consequences. In evaluating aducanumab, the FDA faced a number of trade-offs. It was clear from most observers examining the research that the medication, which supposedly slows down the progression of Alzheimer’s, is not a sure thing. While one major trial affirmed the efficacy of the drug, another analysis concluded that the drug did not work as intended. Safety wasn’t an issue with this drug because there was agreement that side-effects were well-managed over the course of the drug’s administration. And overall, rates of adverse events appear to be similar between the placebo given during the trials and high doses of the medication.

The question therefore boiled down to whether the FDA should approve a largely safe drug that may well slow the progression of a devastating disease with a 100 percent fatality rate. The FDA wisely opted to err on the side of hope, but members of the agency’s “Peripheral and Central Nervous System Drugs Advisory Committee” were none too pleased. All but one of the committee’s 11 members voted against green-lighting the medication (with the final member voting “uncertain”). Harvard Medical School professor Dr. Aaron Kesselheim penned a sharply worded resignation letter following the FDA’s approval of aducanumab, calling the agency’s verdict, “probably the worst drug approval decision in recent U.S. history.”

In his letter, Dr. Kesselheim raises some interesting concerns not directly related to the scientific nitty-gritty of the decision. The medical expert fears that, should the FDA continue to green-light drugs that may wind up not working, public trust in the agency may erode while the healthcare system becomes even more expensive. The fragile nature of the FDA’s public trust, though, runs far deeper than any one agency approval decision. Congress requires the agency to attest to not only the safety of medications, but also the effectiveness of drugs prior to approving them. It is therefore difficult to trust the agency if the FDA gives the seal of approval to a medication and then the drug turns out not to work.

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