When Robert Califf was selected by President Biden for a second stint as FDA commissioner, we called it a safe but uninspired choice. Unfortunately, we have been proven right.
Califf is a distinguished academic cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at organizational levels below the commissioner, and he seems unwilling to engage with them. He has also made it clear that he’s not interested in criticism from the public, even though the FDA is required by law to consider public comments as part of the rule-making process.
Califf did give some reason for hope last summer when he commissioned a review of the agency’s food and tobacco regulatory programs. On the food front, the report echoed criticism from members of Congress, industry and public interest groups that there isn’t a single chain of command among various FDA food oversight offices. However, a diverse group of stakeholders are unhappy with the reorganization plan FDA announced in January and fleshed out further in late February because it doesn’t fully integrate the all-important food inspection work into the new Human Foods program. If Califf doesn’t correct that soon, industry and consumer groups might ask Congress to do it instead.
A more comprehensive reorganization and improved supervision might prevent embarrassing regulatory excesses such as the formal Warning Letter that FDA sent to a Massachusetts bakery for including “love” in its 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.
The report directed its sharpest criticism at the FDA’s Center for Tobacco Products for a litany of operational missteps, directionless policymaking and self-inflicted legal problems. The report even pointed out “a lack of clarity about the distinction between, and the intersection between, policy and science.”
More specifically, the report’s expert panel “was unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.”
The FDA’s February 24 response to the report on tobacco policy makes the agency’s widely criticized response to the food report look good by comparison. Rather than exhibit contrition (for his predecessor’s failures), Center for Tobacco Products Director Brian King doubled down on the regulatory gobbledygook: “Effective immediately, CTP will initiate the development of a comprehensive 5-year strategic plan, building upon the foundation of the center’s previous strategic plans.”
If only there had been a previous strategic plan! (Our prediction: Expect the FDA to go to Congress for additional funding to implement cherry-picked, largely ineffectual responses to the report.)
The FDA’s recent approach to COVID-19 has also been widely viewed as a disappointment. Perhaps the most egregious failure has been its unwillingness to approve, even under Emergency Use Authorization, a new drug called PEG-lambda interferon that performed well in a medium-size Phase 3 trial to treat COVID-19 infections.
Both primary endpoints of the trial — 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 the PEG-lambda experienced no more side effects than those who received a placebo.
A reminder to Dr. Califf: Ensuring food safety, regulating tobacco products rationally, and getting new drugs to patients to treat serious illnesses are the foundations of the FDA’s mandate.
What we need, but are not getting, is bold remedies for the agency’s well-documented shortcomings.