The FDA has problems in many of the product areas it oversees – slow approval of drugs; unnecessary, prolonged shortages of infant formula; and problematic, ineffective regulation of tobacco products, among others. To his credit, the agency head, Commissioner Dr. Robert Califf seems to realize that. In July, he acknowledged that "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."
To accomplish that, he commissioned a report to recommend corrective actions.
So far, so good.
Unfortunately, instead of soliciting a truly independent, expert analysis of the FDA's problems, Califf adopted what is sometimes called the Burger King Approach to obtaining advice, named after an advertisement for the fast-food chain that promised that you pay your money and "You Have It Your Way." Califf tasked the Reagan-Udall Foundation, which FDA describes as both "a partner organization" and an "independent" group, to evaluate the agency's food and tobacco programs and report back in 60 days.
In truth, the foundation, created by Congress and largely funded by the FDA, is far more an FDA partner and collaborator than an independent group: Califf and two former FDA commissioners sit on its board of directors. As though that wasn't sufficiently incestuous, the foundation tapped former Clinton administration FDA Commissioner Dr. Jane Henney to lead the project and Lauren Silvis, a former chief of staff at the FDA and senior adviser at HHS, to lead the review of the agency's tobacco regulatory programs (which she worked on at the agency).
Presumably in an effort to make this project pass the sniff test, Califf (in his role as FDA commissioner, not as a Reagan-Udall Foundation board member) directed the foundation to gather input from outside experts, perhaps recognizing that an evaluation by an "independent" group composed largely of FDA cheerleaders would be suspect.
We're not convinced. If the best solutions to some of the FDA's problems were belt-tightening to reduce excess bureaucracy and ceding some regulatory jurisdiction to the food regulators at USDA, is this the group to recommend it? The Reagan-Udall Foundation review should consider what the first half of its namesake, President Ronald Reagan, might have done and incorporate the types of deregulatory recommendations made earlier this year by the Heritage Foundation.
Sadly, far from embracing austerity and deregulation, Califf has signaled that he'd like the report to recommend additional funding and powers, and, since he's paying for the study, he's likely to have the results his way, to echo the Burger King ad. The regulation of tobacco products, in particular, has been a bête noire for the FDA. The agency's implementation of the 2009 Tobacco Control Act has been a dismal failure. A central component of the law tasked FDA's Center for Tobacco Products with authorizing lower-risk alternatives to cigarettes. Under Presidents Barack Obama, Donald Trump, and now Joe Biden, the FDA envisioned a regulated marketplace of innovative, lower-risk nicotine products that could eventually make cigarettes obsolete.
As a critical deadline to submit product applications came and went, the 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 that the process has neither protected youth from using e-cigarettes nor authorized products that adult smokers have used to quit smoking. The FDA's fumbles have left former smokers who used flavored e-cigarettes to quit smoking with two bad choices: return to smoking or purchase risky black-market vaping products.
There are plenty of FDA challenges that need to be dissected. It's doubtful that the Reagan-Udall Foundation is the organization best equipped to do it.
Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA's Office of Biotechnology. Jeff Stier is a senior fellow at the Taxpayers Protection Alliance.