Much has been written comparing the coronavirus epidemic with the 1918 flu that killed an estimated 675,000 U.S. citizens, about the same number as those who have died with AIDS. During the AIDS epidemic, the Food and Drug Administration was a crucial factor, as it is now. So, the mistakes the FDA made with the AIDS epidemic can be instructive today — if we are willing to learn from them.
The FDA’s greatest mistake on AIDS was the agency’s attempt to delay approval of the protease cocktails for three years to more thoroughly test their efficacy. This was prevented by protesting AIDS activists. Had the FDA succeeded in imposing that delay, AIDS would have taken at least 86,000 additional lives in the United States during those three years.
Neither Congress nor any administration ever called the FDA to account for a near-disaster rooted in its culture of delay. In the coronavirus epidemic, our failure to correct past FDA mistakes may cost untold thousands of lives and has precipitated a shocking economic crisis.
That failure underlies the initial U.S. lag in deploying coronavirus testing. South Korea halted the virus early because they tested early, while our testing was still mired in regulatory mud. The specifics remain murky, but we know where the delays occurred — within the bureaucratic morass of FDA.
First, the FDA ordered Seattle researchers to halt testing because their lab was not certified. The agency also rejected available foreign paradigms to develop the FDA and the Centers for Disease Control and Prevention’s own in-house tests, all the while forbidding private U.S. labs to initiate testing independently. But then, the first FDA-CDC tests had defective reagents.
As if that weren’t enough, the FDA waited two months to lift restrictions on tests from private labs, delayed the sale of home tests, and delayed masks and protective gear. Thanks mainly to the FDA, the U.S. response was bogged down until we passed the point where it was possible to contain the epidemic as South Korea did with its swift, flexible response. Today, supplies of masks and tests, including those for immunity, remain inadequate given demand.
Although President Trump defended the FDA in public, the testing debacle alerted him that the agency would also delay treatments. He ordered the FDA to expedite testing of treatments on an emergency basis — something no president did for AIDS drugs. But the FDA has continued its procedural pushbacks on finding a quick solution to the crisis by using existing drugs. The economy cannot wait for Dr. Anthony Fauci and the National Institutes of Health to develop a vaccine or a cure and then wait, still longer, for the FDA to approve it. We need drugs that patients can take at the onset of symptoms that can help them enough to save their lives. Then, we can all return to our jobs and lives.
Trump gets how regulation can impede innovation. Initially, he hoped to appoint a committed reformer as the FDA commissioner. He considered James O’Neil, a colleague of Peter Thiel, who wanted to reinvent the FDA to make it innovation-friendly. However, pressure from the FDA bureaucracy, backed by Big Pharma lobbyists, prevailed. Michael Gottlieb, Trump’s first commissioner, made improvements but left unchanged the FDA’s culture of delay, and his new commissioner, Stephen Hahn, is no reformer. The big question for Trump: Will the FDA’s coronavirus blunders move him to bring the agency and our entire medical research and development into the 21st century?
With future pandemics, which could be far more dangerous, America will need an FDA on standby, footing like our defenses against terrorism. To survive the terrible economic disruption of modern epidemics, as well as to deal with the spiraling costs of an aging population and the threat of bio-warfare, we need a fast, flexible 21st-century regulatory system. The FDA’s culture of delay, grounded on its antediluvian thalidomide mythology, requires a paradigm shift. We need an FDA whose motto is not “prevent new thalidomides” but “promote new innovation.”
Government protection of public health is essential. But we need to weigh all public needs, including the crucial need to maintain a strong, secure economy. The FDA’s risk-averse culture has time and again hindered crucial innovation, and with the coronavirus, the FDA has become a threat to our economic security. Once the current pandemic is under control, the hard work of reinventing the FDA must begin.
James Driscoll, a Ph.D. and longtime AIDS activist who led the AIDS movement for the FDA reform in the 1990s, is the author of How AIDS Activists Challenged America and Saved FDA from Itself.
