Last year, hashtag activists were ready to #AbolishICE, in part over the deaths of about 20 immigrants in custody in 2020. Protesters called on the government to “defund the police” over more than 1,000 killings by law enforcement during the same period. Those deaths are tragic, and many could have been prevented with better policy. But they pale in comparison to the blood on the hands of the Food and Drug Administration (FDA) over the last 12 months.
Faced with the challenge of COVID-19, the FDA screwed up on nearly every level. When the agency did do something right, it was almost always by making exceptions to its normal policies and procedures.
In this month’s cover story, Ronald Bailey describes some specific targeted changes at the FDA and other bureaucracies that could make a huge difference, as well as some crucial moments when the FDA managed—with great effort—to get out of its own way. This incremental approach to reform is both admirable and realistic. To do as Bailey suggests could help ensure that COVID-19 is our last true pandemic.
But sometimes enough is enough. There was a time when Republicans used to offer up lists of government agencies or cabinet departments they would abolish as part of the presidential primary process—say, the Department of Education or the Federal Reserve. The winner never did abolish anything, of course. But after the year we’ve just been through, nothing should be clearer than the need to eliminate an enormous bureaucracy whose documented failures resulted in the preventable deaths of tens of thousands, maybe hundreds of thousands, of people.
The FDA screwed up in prohibiting researchers from testing affected populations in the early days of 2020, when the virus might have been better contained upon arrival in the United States. It screwed up in refusing to lift requirements for mask manufacturers and by declining to allow good substitutes for masks in short supply. It screwed up by collaborating with the Centers for Disease Control and Prevention (CDC) to protect a monopoly on testing tools that ended in a disastrous shortage. FDA staffers tasked with approving both treatments and vaccines screwed up by delaying meetings and taking days off as Americans were dying in unprecedented numbers of a disease for which the agency had potential solutions. At press time, the AstraZeneca vaccine, which was widely available in many other nations, remained unapproved in the U.S., for reasons that are opaque to Americans desperate to resume normal lives.
But this is nothing new. The FDA started screwing up the COVID crisis long before the first bite of bat soup, by suppressing innovation and experimentation that could have better positioned scientists and researchers to prevent the outbreak from becoming a pandemic.
The agency is large, with a 2021 budget of $6 billion and the equivalent of about 18,000 full time staff. But that’s not the real cost of the FDA. Nobelist Milton Friedman got it right when he said: “The FDA has done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process.”
The FDA is being asked to do an impossible, immoral task—and it is doing it badly. Ordinarily, people tend to discover this one at a time, in moments of personal crisis. A patient with a rare cancer is heartbroken to find out a potential treatment is not approved for use in the United States. A pharmacist who would like to offer a customer suffering from side effects an alternate drug is unable to do so. An entrepreneur who has an idea for a new testing tool gets discouraged when she looks into the approvals she would have to obtain before going to market. People seeking to make decisions about their own bodies that would harm no one else are forbidden from doing so, sometimes literally condemning them to death.
This year, Americans experienced that despair and frustration in unison. As our friends and neighbors sickened and died, the FDA equivocated, procrastinated, and played hot potato with tough decisions, just as it has done with minimal consequences to the agency for decades.
The FDA distorts incentives for pharmaceutical companies in ways that can be hard to see because they have been in place for so long. Much as middle schoolers suffer when their instructor “teaches to the test” at the expense of holistic understanding, customers and patients suffer when drug makers focus on jumping through the FDA’s hoops rather than figuring out the best uses for new compounds or the best way to help their customers.
Even now, with three COVID vaccines approved and on the U.S. market, health professionals are unable to pivot to offering a single dose to twice as many people, despite clear evidence that one shot can be highly effective. Why? Because the FDA approval process is not built to handle that kind of change mid-stride. And methods that would have allowed researchers to formally evaluate the efficacy of a single shot were also not allowed pre-release.
The current system is this: The FDA approves new pharmaceuticals as both safe and effective, in most cases after a laborious and expensive process of many years and many millions of dollars. Pharmaceuticals are only approved for certain uses, but physicians are allowed to use them off-label, which immediately undermines the case for the time-consuming efficacy part of the approval. Sometimes, even though drugs have been approved as safe, they are discovered to be harmful after the fact and have to be withdrawn.
When a disease is a really big deal, as with AIDS or COVID-19, the FDA makes exceptions—especially if political pressure comes to bear. The agency grants emergency use authorizations or convenes special committees. When there’s a sob story, a patient is occasionally allowed the “right to try” a treatment earlier than usual. While more exceptions made more often would be an improvement on the status quo, the need for these exceptions and the extremely high stakes for obtaining them shows that there is something deeply wrong with the underlying process.
Whenever a government agency fails in its mission, there are calls for more funding, more authority, more high-quality leadership. But in this case, there is little reason to believe those things will help; the agency’s mission was flawed from the beginning.
In its 115 years of existence, the FDA has certainly nabbed quacks and prevented harmful drugs from coming to market. The agency has been dining out for decades on the story of how it refused to approve thalidomide for sale in the United States, for instance. With all due respect to that incredible catch, this is like NASA boasting about Tang and Velcro. It’s not that the FDA has never done anything good; it’s that it hasn’t done enough to justify the costs.
Sometimes the costs are clear, as they have been this year in the struggle to get access to vaccines and treatments, or as they have been to the sufferers of chronic or terminal illnesses for much longer. Other times the stakes are low for any individual patient but add up. Thousands, maybe millions, of men with heart trouble take a low dose of aspirin every day to reduce the risk of myocardial occlusion. But for many years after that connection was established, the FDA prohibited aspirin manufacturers from advertising it. That single, seemingly minor restriction contributed to the deaths of many, many thousands of Americans.
Alternatives to regulation can also be hard to envision. But the role of the state, if it has one at all, is to protect rights and guard against fraud, not to prevent people from making risky choices. There are many nonstate mechanisms to ensure a safe and effective drug supply. The courts have a role to play here, one that was stunted when the FDA usurped their function in determining where harm or fraud has occurred. Technology to review consumer products is more robust and easier to use than ever, and there are plenty of other industries where private institutions verify and communicate with the public effectively about quality and safety. Without government-granted monopolies and barriers to entry, drugs would proliferate and prices would almost certainly fall, resolving many issues of access.
At the time of this writing, COVID case counts and deaths were finally falling. But there are still 2,000 Americans dying each day. Not every one of these deaths can be laid at the agency’s door, but each day of delay is one more argument for abolishing the FDA.
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