FDA: Fix Department, ASAP

Published September 19, 2022

Kudos to Food and Drug Administration Commissioner Dr. Robert Califf for acknowledging his agency needs help. Recognizing a problem is a prerequisite to making amends.

On July 19th, Califf conceded, as only a government official could, “the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.” He also commissioned a report to help figure things out.

The FDA’s bungled response to contamination at the Abbott Nutrition infant formula plant in Michigan drew attention to broader problems within the agency’s food regulation bureaucracy.

And after over a decade of tobacco oversight, FDA’s Center for Tobacco Products (CTP) has little to show for its effort. Most recently, it denied Juul’s application to keep its remaining e-cigarettes on the market for sale to adults. The ban was temporarily blocked by a federal court. Days later, CTP all but admitted it botched its highly anticipated review of the science Juul submitted in the application.

In acknowledging both of these “challenges,” the FDA tasked the The Reagan-Udall Foundation, which FDA at once describes as both “a partner organization” and an “independent” group, to evaluate the food and tobacco programs and report back in 60 days.

The foundation, created by Congress and largely funded by the FDA, has close ties to the FDA, including board seats held by both the current and former commissioner. In fact, the foundation tapped former Clinton FDA commissioner Dr. Jane Henney to lead the project.

Dr. Califf (in his role as FDA commissioner, not as Reagan-Udall Foundation board member) was clever to direct the foundation to gather input from outside experts, perhaps recognizing that any evaluation by an “independent” group led partly by himself and FDA alumni is likely to be seen as tainted. It’s like an alcoholic asking his drinking buddies to help him sober up. They may mean well, but is this a smart way to obtain objective help?

On the food front, critics like Rep. Rosa DeLauro (D-CT) point out that there are two food divisions within the FDA, which raises legitimate chain of command concerns. But Califf has signaled that he’d like the report to recommend additional funding and powers. He told Food Safety news “that while Regan-Udall will look at chain of command issues, that’s not the only thing on the table.”

Instead, the foundation should consider what the first half of its namesake might have done, and incorporate the types of deregulatory recommendations made by the Heritage Foundation. The infant formula shortage, which is not completely resolved, should have been addressed with regulatory flexibility, less protectionism and moves to use the federal government’s buying power to broaden the dangerously narrow domestic market.

On tobacco, the FDA’s implementation of the 2009 Tobacco Control Act has been a failure. A central component of the law tasked CTP with authorizing lower risk alternatives to cigarettes. Under Presidents Obama, Trump and now Biden, the FDA envisioned facilitating a regulated marketplace of innovative, lower-risk nicotine products to eventually make cigarettes obsolete.

Yet as a critical deadline to submit product applications came and went, CTP failed to publish product standards that would be the basis of the applications. Instead, applicants were left to guess what evidence regulators needed to be persuaded that the products would protect public health.

It’s no wonder the process has neither protected youth from using e-cigarettes nor has it authorized the products, like Juul, which adult smokers have used to quit smoking. Instead, so far, it only authorized a handful of e-cigarettes — ones that very few adult smokers have used to quit.

The regulatory blunders have fostered innovation-stifling uncertainty and invited litigation that the FDA has been unable to fend off to date.

Worse, the botched process has left former smokers who used flavored e-cigarettes to quit smoking with two bad choices: return to smoking or purchase risky black-market vapes.

When the FDA issued its short-lived denial to Juul, it wasn’t driven by concerns over youth usage. In fact, Centers for Disease Control data shows that regular use of e-cigarettes by youth has fallen significantly after the federal minimum age to buy tobacco products was raised to 21. Rather, the FDA opaquely alluded to toxicological concerns. Juul responded that toxicology data and analysis made up a large portion of the application. And, astonishingly, in withdrawing the denial, the FDA apparently agreed.

What gives?

The Reagan-Udall Foundation might find clues when it considers the recent fate of CTP’s leadership.

Longtime director Mitch Zeller, an early and energetic proponent of using regulation to switch smokers to lower-risk products retired earlier this year, before the FDA issued critical e-cigarette rulings. Then, in July, the CTP’s widely respected top scientist, Dr. Matt Holman, left the agency to take a position with tobacco giant Philip Morris International.

These unusual developments support an even more shocking conclusion: PMI’s stated commitment to creating “a smoke-free future,” as well as similar goals by other industry leaders, is more credible than the FDA’s promise to do the same… at least according to the FDA’s most prominent leaders.

The FDA should ask the foundation to consider whether political pressure stoked by anti-vaping activists funded by Michael Bloomberg are leading the FDA down an unscientific path that winds up only protecting cigarettes.

A truly independent analysis of the CTP’s work should find that FDA must reverse course by issuing clear product standards before requiring manufacturers to submit applications, and instead of using broad product bans, rely on educational campaigns and bans on sales to minors to minimize youth use. In sum, because a regulated but robust market of appealing reduced-risk products is consistent with protecting public health as envisioned by the law, the FDA must work with, not against, private sector innovators to once and for all make cigarettes a thing of the past.

First published at Real Clear Policy.