The FDA secured authority over deciding which drugs will be prescription‐only and which will be available over the counter in 1951. That power denied women ready access to emergency contraception — the “morning‐after pill” — for more than twelve years, despite the recommendations of expert advisory panels and its availability in Europe. It ultimately took a court order for women to get access to the drug without restriction.
To this day, the FDA still requires a prescription for hormonal contraceptives, despite appeals from the American College of Obstetrics and Gynecology and the American Academy of Family Practice to allow American women to join women in 102 other countries who get birth‐control pills over the counter.
For years, the FDA deprived people of access to safe, non‐sedative antihistamines without a prescription while permitting them to buy much more dangerous sedative antihistamines over the counter. And the FDA still hinders efforts to combat drug‐overdose deaths by classifying the overdose antidote naloxone as prescription‐only, despite tacitly admitting it should not require a prescription.
Self‐administered, at‐home tests for various medical conditions have required pre‐market FDA approval since 1976. The FDA’s paternalistic concern for consumers has delayed or blocked patients from accessing at‐home pregnancy tests, at‐home HIV tests, at‐home genetic‐screening tests, and most recently, at‐home COVID tests.
FDA procrastination in approving drugs for the market, sometimes influenced by vocal special‐interest groups, causes countless unseen patients to suffer or die waiting for permission to use a lifesaving drug. This phenomenon, known as drug lag, spurred civil disobedience from AIDS activists in the 1980s and inspired the “Right to Try” movement of the last decade.
The severe costs of securing FDA approval, in money and time, are responsible for what health economists call drug loss, the phenomenon whereby pharmaceutical manufacturers choose not to invest in the development of new drugs because they don’t believe they’ll be able to recoup the considerable approval costs.
Aside from political pressures, as Nobel‐winning economist Milton Friedman pointed out, FDA regulators fear the fallout from potential adverse reactions to approved drugs. Yet they are insulated from the unseen consequences of drug lag and drug loss, so they have an incentive to maintain the status quo.
In a Cato Institute white paper, Michael F. Cannon and I have traced the history of how private organizations monitored, reported on, and regulated pharmaceuticals prior to the Food, Drug, and Cosmetic Act of 1938. Organizations such as the U.S. Pharmacopeial Convention and the American Medical Association Council on Pharmacy and Chemistry engaged in safety and quality testing of drugs on the market. Only drugs with the AMA’s Seal of Acceptance could be advertised in the various AMA journals. The AMA’s Chemical Laboratory continuously tested products for purity and composition.
The AMA’s Council on Pharmacy and Chemistry was shuttered in 1955, as the FDA continued to accumulate unchallenged authority to regulate drugs. But even today, the AMA maintains a registry of reported adverse drug reactions. And other organizations, from Consumer Reports to health‐insurance companies to academic journals to foreign regulatory agencies, continuously monitor and report on the safety and efficacy of drugs and vaccines. The FDA itself relies on research and trials conducted in the private sector.
In 2015 and again in 2019, Senators Ted Cruz (R., Texas) and Mike Lee (R., Utah) introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act. The proposal would allow consumers to choose between FDA‐approved drugs and drugs approved by the regulatory agencies of a number of developed countries. Though it is too deferential to FDA regulators and doesn’t provide nearly enough choice, it would still be a step in the right direction. But it failed to advance out of committee both times it was introduced.
The COVID-19 pandemic has provided many examples of how regulations and bureaucratic stasis can impede a rapid and nimble response to a public‐health emergency. To deal with the emergency, the FDA temporarily suspended many of its regulations and other red tape — a tacit admission that they were blocking the way.
If anything good comes out of the pandemic, let it be a widespread recognition that the 21st century has no use for this sclerotic, politicized relic of 20th‐century central planning.