Under the FDA, drug manufacturers are required to prove their medicines are “safe and efficacious.” This involves costly and time-consuming clinical trials, which reduces the occurrence of bad drugs but slows introduction of good drugs.
An ideal FDA would balance these two effects (safety versus speed) in a thoughtful manner; a real-world FDA is likely to err toward excessive caution. If the FDA approves a bad drug, the adverse outcomes make headlines.
If the FDA delays a good drug, the cost is less obvious because most of those affected are not aware their illness could have been treated more effectively. A great deal of evidence supports this perspective and estimates huge life-saving benefits would be derived from greater speed.
In Libertarian Land, private mechanisms would achieve a better balance between speed and safety. Drug companies would conduct clinical trials, but with less bureaucracy and delay. They would also allow — without government approval — experimental use of medications that have not completed their clinical trials.
Drug companies would avoid selling bad drugs because the negative publicity reduces profits (as does killing off one’s customers).
Independent private groups, such as Consumer Reports, the American Medical Association, hospital chains, insurance companies, professional journals, and others would assess the information provided by drug companies, facilitating informed decisions by patients and doctors about which medicines to use.
If these private mechanisms went wrong, those harmed would sue manufacturers for damages using the tort liability system. Manufacturers understand the risks of such lawsuits and would weigh the costs of marketing a bad drug too quickly against the lost profits from marketing a good drug too slowly.
Libertarian Land would also allow human challenge trials, in which volunteers or paid participants receive an experimental medicine and are then exposed to the disease that the medication attempts to treat.
This would allow trials with only, say, a hundred participants to suggest within weeks whether the medication is effective, rather than requiring hundreds of thousands of participants and taking months or years.
When the results from a challenge trial were positive, the trial would expand, providing more information and protecting more people. Those most at risk get the medication without regulatory impediments.
This is especially valuable for infectious diseases, since fewer cases means reduced spread in the population generally. Meanwhile standard clinical trials would occur simultaneously, confirming the challenge trial results.
This approach would likely have made a huge difference in limiting the Covid pandemic. Moderna had the formula for its mRNA vaccine by mid-January, 2020, when caseloads were still low. A human challenge trial would have confirmed effectiveness within weeks, allowing ramp up of vaccination programs within months, rather than the ten months it took to even start vaccinations under the FDA.
In Libertarian Land, large-scale production would happen quickly due to the absence of barriers from the FDA, the Centers for Disease Control and Prevention, or other federal and state policies.
Some might think that addressing the FDA’s excessive focus on safety implies reform rather than elimination, but that is a fool’s errand. Any agency, once created, will see its mission expand, and the FDA is a case in point.
Until 1962, it conditioned drug approvals only on safety, but in response to the thalidomide tragedy, the Kefauver-Harris amendment mandated that the FDA determine efficacy as well, thereby increasing delays. As with weeds, the only way to prevent re-emergence of harmful effects is to root out the source entirely.
