The FDA continues to fail the American public
The Food and Drug administration’s role in approving vaccines to combat the coronavirus shed a new level of scrutiny on the critical government agency and its gatekeeper role in America’s health system.
The FDA managed to overcome its bureaucratic tendencies, approving coronavirus vaccines relatively quickly. But as Michael F. Cannon writes, we shouldn’t take our gaze off the FDA for this apparent job well done. If anything, Cannon says, the FDA deserves even greater scrutiny for its role in keeping life-saving drugs and treatments off the U.S. market:
Between 2000 and 2010, the FDA blocked U.S. patients from accessing a total of 37 novel drugs available in Canada and Europe. In each case, “no other FDA‐approved prescription medicine had the same mechanism of action.” Ten of the drugs treated diseases “for which no alternative therapy was available in the U.S.A.”
The FDA has blocked life-saving vaccines. In 2013, Australia, Canada and the European Union approved a novel vaccine for a strain of meningitis with a case fatality rate of 10%. That year, multiple American universities suffered fatal outbreaks. University officials had to beg the FDA for permission to use the vaccine to protect their students. The FDA relented — in 2015.
Some members of Congress propose freeing Americans to purchase some medicines, from some countries, in limited circumstances. That might be a good first step. Yet all patients have a fundamental human right to make their own medical decisions.
Congress can restore that right by outright eliminating barriers to purchasing drugs available in other countries. Doing so would have allowed U.S. patients to access those 37 novel drugs a median of 13.6 months earlier. It would allow COVID patients to access molnupiravir today.
Getting a bureaucracy to change its stripes, never mind its CYA checklist, is a mammoth undertaking. But it can be done…if the public demands Congress do its job of oversight and accountability.