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National Review

The Johnson & Johnson-Vaccine Fiasco Is Business as Usual for the FDA

Last week, the Food and Drug Administration reported that six women of childbearing age who received the one-dose Johnson & Johnson COVID vaccine contracted a rare form of blood clotting in the venous drainage of the brain — one associated with a low platelet count. Sadly, one of the six died and another is in critical condition at the time of this writing. The FDA recommended “pausing” the use of the J&J vaccine until more information can be gathered. But even though this was less than a one-in-a-million event — more than 6 million Americans have received the J&J vaccine — and the risk of blood clots in women taking oral contraceptives is higher, the advisory panel established by the FDA to study the problem punted. It decided to not decide — waiting instead to see if any more cases get reported. We may never know how many people will die from COVID who would have gladly taken their chances with the vaccine. The FDA is also sitting on a decision to grant emergency-use authorization to the AstraZeneca COVID vaccine. Though it has been widely used throughout the developed world, reports of the same rare complication resulting from the AstraZeneca vaccine — which, like the J&J vaccine, uses an adenovirus as a vector — have kept the FDA from approving its use. Yet the U.S. government is giving roughly 4 million doses of its stock of the vaccine to Mexico and Canada. The FDA won’t allow Americans to act on their own assessments of the risk of dying from COVID versus the risk of a complication from these two vaccines. Instead, it has forced the public to accept the risk-benefit assessment of the majority of its advisory-committee members. And this is nothing new: For more than 80 years, the FDA has infringed on the right of people to make their own lifesaving decisions. 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.