The FDA’s Dysfunction Is A Public Health Crisis Of Its Own
Earlier this month, President Biden tapped Dr. Robert Califf to lead the Food and Drug Administration. The agency had been operating without a Senate-approved commissioner for almost a year.
In my last column, I detailed how the FDA’s failures reviewing and approving tests for COVID-19 have prolonged the pandemic. This week, we have a new source of dysfunction to explore—the FDA’s foot-dragging on antiviral pills that treat COVID-19 and booster shots. Americans are needlessly suffering—and dying—because of that dysfunction.
Since President Biden took office, FDA veteran Dr. Janet Woodcock has served as interim commissioner. It’s unclear why the president waited 10 months to nominate a permanent head in the midst of a pandemic.
Interims are less than ideal for a few reasons. They may struggle to convince rank-and-file employees to follow their orders, given that the bureaucracy knows someone else will eventually come along. Companies with business before the FDA, meanwhile, may tread cautiously, as an unpredictable regulatory process can be extremely costly.
If ever there were a time for strong leadership that can bring clarity for employees and regulated companies alike, it’s during a pandemic. Instead, the bureaucracy has just limped along.
Urgency doesn’t appear to be in the agency’s vocabulary. An FDA advisory committee is not scheduled to consider for emergency use authorization an antiviral pill from Merck and Ridgeback Therapeutics that appears to cut the risk of hospitalization and death from COVID-19 by half until November 30.
Merck applied for an EUA October 11. It’s flabbergasting that it’s taken the FDA more than a month and a half to get a meeting on the calendar to consider that application. Since October 11, the seven-day average of daily COVID-19 deaths has never fallen below a thousand.
Colloquially, a thousand people are dying a day. And the meeting is still more than a week away!
Then there’s Pfizer’s COVID-19 pill, which appears to reduce the risk of hospitalization or death by 89% compared to a placebo in high-risk adults with COVID-19. The data were so promising that Pfizer stopped the trial of the drug. Continuing with it—and depriving the placebo group of a treatment with such strong evidence of effectiveness—would’ve been considered unethical.
In other words, it’s unethical to deprive trial participants of Pfizer’s pill, given how effective it’s proven thus far. But ordinary patients can’t have it until the FDA says so. And the FDA hasn’t yet said when it will consider Pfizer’s drug for an emergency use authorization.
If present trends hold, thousands of people will die of COVID-19 between now and November 30. It’s not unreasonable to assign the FDA some responsibility for those deaths.
The FDA has also finally been dragged into doing something on COVID-19 booster shots. On Friday afternoon, November 19, the agency green-lit boosters of the Pfizer-BioNTech and Moderna vaccines for everyone over the age of 18, provided that six months had passed since their last shot.
Several states had previously taken to just ignoring the agency’s guidance. State officials in California, Colorado, New Mexico, Arkansas, West Virginia, Kansas, Maine, Rhode Island, and Louisiana had already opened up eligibility for boosters to all fully vaccinated adults before the feds weighed in.
Gov. Jared Polis, D-Colo., justified his decisions to expand access to boosters on CBS’s “Face the Nation,” saying, “I’ve been very frustrated with the convoluted messaging out of the CDC and the FDA. Everybody should get the booster after six months. The data are (is) incredibly clear that it increases your personal protection level.”
The FDA’s perpetual tardiness is a product of its culture—and the incentives its employees face. Agency officials don’t get in trouble if a drug or medical device that could save lives never makes it to market. But if an FDA-approved product injures or kills someone, then the agency could take some serious blows from Congress and the public.
Alex Tabarrok, an economics professor at George Mason University, has called the people who die when the FDA fails to approve a good drug the residents of an “invisible graveyard.” That graveyard is much fuller today, thanks to the agency’s slow response to COVID-19.Read More