The Collapse of the FDA

Summary

By May, Kennedy and his deputies were taking direct aim at vaccines. They announced that new clinical trials would be required for Covid boosters, even though the shots have long been considered both safe and effective. At the C.D.C., Kennedy himself would soon fire the entire 17-person expert committee that advises federal health officials on vaccine recommendations (not whether shots should be approved, but who should receive them). Their replacements — eight people with little to no relevant expertise and some with obvious conflicts of interest — quickly revoked the government’s longstanding recommendation of a subset of flu vaccines that contain the preservative thimerosal. Vaccine skeptics suspect the preservative of causing autism, despite numerous studies showing the compound to be harmless.One thing that appeared not to have changed was the F.D.A.’s relationship with drug makers. In June, Makary and his deputies began a six-city listening tour with drug-industry executives that was, despite all the talk of radical transparency, closed to the public. (According to Nixon, the communications director at H.H.S., the tour was focused on industry stakeholders, and public transparency would be preserved through other forums.) Later that month, Makary announced a voucher program that would shorten drug review times from 10 to 12 months to just one or two for companies whose products met certain criteria. He also laid out a new list of agency priorities in The Journal of the American Medical Association that, for drugs, seemed to come down to two things: faster reviews and more approvals. “Their paper reads like it’s straight from pharma’s playbook,” Ramachandran told me. “They criticized expedited drug reviews for years, especially with respect to Covid vaccines, saying that it turned the F.D.A. into a rubber stamp. But now they want to do the exact same thing for as many other drugs as possible.”Reports from inside the agency remained bleak. Some of the civil serva...