The FDA and the Biden administration’s nominee for commissioner, Robert Califf, are both deeply flawed.
By Shannon Brownlee and Jeanne Lenzer | 20 January 2022
WASHINGTON MONTHLY — If Robert Califf, the White House nominee for commissioner of the U.S. Food and Drug Administration, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. Meanwhile, about a third of Americans refuse to get vaccinated for COVID-19, in part because they distrust government and scientific institutions.
In the case of the FDA, at least some of that mistrust is deserved even if the COVID vaccines are generally safe. (We’ve both taken them.) The most recent FDA disaster erupted in June, when officials approved the Alzheimer’s drug Aduhelm over the objections of the agency’s biostatistician and an 11-member committee of expert advisers. The data submitted by Biogen, the drug’s manufacturer, failed to show that Aduhelm is effective. It also poses a significant risk of harm, including brain bleeds and swelling in about a third of test subjects. Agency higher-ups decided to overlook these shortcomings and put the drug on a fast track for approval.
Three members of the FDA advisory committee promptly quit in protest over the Aduhelm decision, and multiple hospital systems have refused to administer the wildly expensive drug, fearing it doesn’t work, will hurt patients, and will break their budgets. (The drug is priced at $28,000 a year per patient.) Thanks to its eye-popping price, the Centers for Medicare and Medicaid Services raised its premiums by 14.5 percent, the largest increase in its history, half of which was to accommodate this one drug. It’s no wonder that European regulators gave Aduhelm a thumbs-down, and Japan appears ready to follow suit. On January 11, the CMS announced its preliminary decision not to pay for Aduhelm except for patients enrolled in high-quality clinical trials, saying “important questions” remain about the drug. That decision should be finalized later this year. […]