We Don’t Need the FDA

In late August 2021, The Food and Drug Administration (FDA) approved the Pfizer COVID vaccine. At this time, the vaccines developed by Moderna and Johnson & Johnson have not been approved by the FDA. Despite the delay in approving the Pfizer vaccine, and the lack of approval for the Moderna and Johnson & Johnson vaccines, by late November more than 450 million doses of the vaccines had been administered in the United States.

So, while government officials have spent months deciding whether we should be allowed to get vaccinated, tens of millions have acted on their own judgment. We were competent to judge the efficacy and safety of the vaccines ourselves, and we didn’t wait for the FDA’s bureaucratic stamp of approval to act on that judgment.

The vaccines were available because the FDA granted Emergency Use Authorization (EUA). But even the process of obtaining an EUA took Pfizer weeks. During that time, millions of Americans were infected. The resulting suffering and deaths were caused because it is illegal for pharmaceutical companies to sell drugs without the FDA’s approval.

In regard to the vaccines, the FDA did nothing to protect us. What it did do was delay distribution and prevented millions from receiving a life-saving medicine. And the vaccines are not an isolated example.

For decades, the FDA has routinely denied terminally ill patients access to experimental drugs that might save their lives. If these patients, in consultation with their doctor, choose to try an experimental drug, they should not need the FDA’s approval.

Pharmaceutical companies have a vested interest in producing safe and effective products. Even without the FDA, they would engage in clinical trials to determine safety and efficacy—harming one’s customers is not a good business strategy.

The vaccines have demonstrated that we don’t need the FDA. What we do need is the freedom to act on our own judgment. For that to occur in health care, we must abolish the FDA.