The Food and Drug Administration is the nation's most ubiquitous regulatory agency, responsible for overseeing products — drugs, medical devices, tobacco products, and most foods — that account for about 20 cents of every dollar spent by consumers. It is currently going through a rough patch, with priorities that seem to make little sense.
Drug approval and enforcement actions are falling through the cracks. An example of the former is the agency's recent failure to approve, even under emergency use authorization, a new drug called PEG-lambda interferon that performed well in a medium-sized phase 3 trial to treat COVID infections. The results, published in February, showed that patients who got the drug within three days of showing symptoms were 51% less likely to be hospitalized or to need an extended visit to an emergency room compared with those given a placebo and that the benefit was even greater (89%) in the unvaccinated.
In summary, the two primary endpoints of the trial were met: COVID-related hospitalizations and emergency department stays of longer than six hours were significantly lower in patients who got the drug. Another critical finding was that the patients who received PEG-lambda experienced no more side effects than those who received a placebo. (Paxlovid, the leading COVID drug, is very effective but has many potentially troublesome drug-drug interactions with other medicines.)
As a 15-year veteran of the FDA who evaluated drugs in the same class as PEG-lambda, I believe on the basis of publicly available data that it could at least have been approved under emergency use authorization . PEG-lambda could be especially valuable in view of the growing dominance of a new subvariant of SARS-CoV-2 omicron called XBB.1.16, which is both more transmissible and more prone to immune escape than its predecessors. And the virus continues to evolve.
Another recent example is the agency's slow-walking of approvals for vaccines to prevent respiratory syncytial virus infections, viral enemy number one for children. RSV results in more pediatric hospitalizations than any other single cause, and pediatricians have long been helpless to stem the tide of RSV-infected newborns, who are at particularly high risk for landing in the hospital. (The first RSV vaccine was finally approved by the FDA on May 3.)
The FDA also came up short on the debacle of the infant formula shortage, which it seemed not even to notice, let alone take action to address, for many months.
Among the FDA's worst shortcomings is its lax oversight of dietary supplements, even when they are adulterated or misbranded. A recently published study of the melatonin concentration in more than two dozen recently launched gummies containing dietary supplements found that almost all of the products had greater than 10% more melatonin than advertised. One product contained three times the amount indicated on the label. This is a significant public health problem because large amounts of melatonin have adverse effects on children, which has prompted an exponential increase in melatonin-related poison-control calls in recent years .
At the same time that the FDA is failing to fulfill some of its basic responsibilities, it is wasting time and resources on trivia. An example is the update of the agency's 2022 list of food regulations that allows pet dogs, not just service animals, "in outdoor dining areas, where approved" by local authorities. Cats and other pets are prohibited. It's unclear from where the FDA thinks it derives jurisdiction over this.
More evidence that the FDA is going to the dogs is the warning letter sent to a Massachusetts bakery for including "love" in its product ingredient list. The reason? "'Love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient," it stated.
Such gratuitous actions are not cost free. The drafting of policies and action letters requires surprising numbers of bureaucrat hours as documents migrate up the food chain and are reviewed and signed off at higher and higher levels.
We need more strategic priorities and better management at the FDA. I am not optimistic that we'll get them.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished fellow at the American Council on Science and Health. He was the founding director of the FDA's Office of Biotechnology.