The FDA is influenced by much more than science.
On September 1, the Food and Drug Administration announced the sudden retirements of the director and deputy director of the FDA’s Office of Vaccine Research and Review. Most news reports characterized the departures of Dr. Marion Gruber and Dr. Philip Krause as resignations. The respected scientists were purportedly disturbed by political pressure from the White House and the Centers for Disease Control and Prevention to quickly approve giving COVID-19 booster shots to everyone over age twelve whose second jab was at least eight months earlier. According to Politico, the FDA is “facing a potential mutiny” by its staff and outside vaccine advisers, angry that they are being bypassed and that the FDA is being pressured by the administration into deciding on boosters prematurely.
Recent studies show antibodies against COVID waning over time. This has led some countries, such as Israel, to offer booster shots to anyone over age twelve who got their second Pfizer dose more than five months ago. This may be why President Biden muddied the waters last week by suggesting that boosters might be given to people whose vaccinations are just five months old, after the administration announced two weeks earlier that boosters will be given to people with eight-month-old vaccinations starting September 20.
Many experts in the field are not yet convinced of the need for boosters. Some contend that antibody levels tell only part of the story. They argue that although it is common for antibody levels to wane over time, T-cell immunity and immune memory often persist and recharge antibody production and the immune response if the virus attacks again. They and others worry that public-health officials may be “jumping the gun” by recommending boosters. Pfizer has submitted only early trial results to the FDA to support its claim that boosters are needed, and phase III trial data have not yet been delivered. The FDA needs the data to determine if giving a third dose to the general public so soon after the second dose is a safe and effective allocation of vaccine supplies.
It should come as no surprise that politics and special-interest pleading affect FDA decisions. The history of the FDA is rich with such examples. Despite the overwhelming recommendation of a 2003 FDA advisory panel that the emergency contraceptive Plan B be reclassified from prescription-only to over-the-counter, it took ten years and a federal court order before that finally happened for women of all ages. And for many years, at the behest of manufacturers, several non-sedating antihistamines remained classified as prescription-only, so they could bring a better price from the insurance companies that pay for prescription drugs. The drugmaker simultaneously urged European regulators to approve the drugs for over-the-counter access. Meanwhile, American consumers were able to buy only sedating antihistamines, which are more dangerous than non-sedating, without a prescription.
The FDA is just as bad when it comes to oral contraceptives. The American College of Obstetrics and Gynecology and the American Academy of Family Practice have, for decades, urged the FDA to make them available without a prescription, as is the case in 102 countries. Yet the FDA defers to outside interests and continues to require a prescription.
Although overdose deaths hit a record 93,000 last year, the FDA still hasn’t made the opioid-overdose antidote naloxone available over the counter. The agency has practically pleaded with naloxone makers to ask the FDA to reclassify the drug, even though reclassification doesn’t depend on the makers’ request. The makers probably realize prices tend to drop when drugs move from prescription-only to over-the-counter.
While some complain that politics interferes with the FDA’s mission, the fact is the FDA’s powers are inherently political. When control of drug development and availability is concentrated in a government monopoly instead of being dispersed among private entities competing in an open market, special-interest pleading and political influences become unavoidable.
As Michael F. Cannon and I point out in our white paper, before the Food, Drug, and Cosmetic Act (FDCA) of 1938, the right of the people to self-medicate was sacrosanct and respected by the government. In fact, the framers of the FDCA gave a rhetorical nod to this right in the Congressional Record. Over the years, power has continually accrued to the FDA, crowding out and rendering superfluous various private testing and certification organizations. Many, such as the U.S. Pharmacopeia and the American Medical Association’s Council on Pharmacy and Chemistry, were evaluating and standardizing drugs and formularies long before Congress got into the act. Crowding out by the FDA caused the AMA to close the Council on Pharmacy and Chemistry in 1955. It then initiated a registry to report adverse drug reactions. From 1938 to 1962 the FDA relied on the National Research Council of the National Academy of Sciences — a private organization — to evaluate and certify the efficacy of drugs that the FDA determined were safe.
The zigzagging and inconsistent recommendations of government and public-health officials over the past 18 months have sown a justified distrust among the public. When the FDA renders its verdict on COVID boosters, we will all be left wondering how much of the decision was really based on “the science.” Regardless, the COVID-19 virus is destined to become endemic — as endemic as the politics in our government agencies.