Issues & Insights

The FDA Needs Reform – Biden’s Nominee Is Not the Person to Do It

When President Joe Biden nominated former Obama-era Food and Drug Administration Commissioner Dr. Robert Califf to return to his old post, he made what was widely seen as a safe, if uninspired, choice. He easily sailed through a Dec. 14 Senate committee hearing to vet him. “[Califf] gushed about his love of high-quality data, skillfully navigated questions on hot-button topics like abortion and drug pricing, and even had personal anecdotes about COVID-19 testing and opioid prescribing at the ready,” according to Stat.

Since then, Califf has encountered some opposition to his confirmation, even from Democrats. Sen. Joe Manchin, D-W.V., cited the need for a change in “culture at the FDA.” And from his perch in congressional La La Land, Sen. Bernie Sanders, D-Vt., doubted that Califf would be “willing to stand up to the greed and power of the pharmaceutical industry.” He is shocked – shocked – that former FDA commissioners would be hired as consultants to drug companies.

However, the final Senate vote is likely this week, reflecting that Majority Leader Chuck Schumer thinks he has the votes for confirmation.

Dr. Califf is a distinguished cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at the organizational levels below the commissioner. The FDA, a huge and critically important but dysfunctional organization, now needs a bold, clear-thinking reformer to lead it, but Califf, the ultimate insider, has the ideal resume to keep it on the wrong path.

Government regulation offers some reassurance to the public, to be sure, but when it is wrong-headed or merely fails to be cost-effective, it actually costs lives – directly by withholding life-saving and life-enhancing products, and also indirectly by diverting societal resources to gratuitous regulatory compliance.

The stakes are high. The FDA’s purview is wide, regulating pharmaceuticals, medical devices, food, and tobacco products that account for about 20 cents of every consumer dollar. The FDA has pushed the average cost (including out-of-pocket expenses and opportunity costs) to bring a new drug to market to more than $2.5 billion. That ensures that many new drugs will have a hefty price tag, and that others won’t get developed at all.

Stat News’ glowing coverage of the nomination is revealing – in an unintended way: “Califf might not get the credit, but he was actually one of the FDA officials at the center of the agency’s early efforts to regulate e-cigarette companies.”

Well, Califf’s approach has led to some awful outcomes. The FDA has almost entirely extinguished the legal market for lower-risk alternatives used by adults to quit smoking. At the same time, unscrupulous businesses continue to provide headline-grabbing talking points to opponents of science-based tobacco harm reduction. And now, it looks as though the Supreme Court may need to decide whether the FDA’s messy rule-making ran afoul of administrative law. A new FDA commissioner will be especially important at this moment in time, as the longtime director of the FDA’s Center for Tobacco Products, Mitch Zeller, recently announced his plan to retire next April.

Putting FDA on the right track will require toughness and discipline at a federal agency where more than 99.9% of the employees are civil servants who cannot be fired, even for incompetence or insubordination. Therefore, the most important role of the commissioner is to ensure that policies are scientifically defensible, that the agency’s culture reflects the appropriate level of risk-aversion, and that managers manage effectively, but that’s difficult, because the incentives that guide bureaucrats are perverse.

The late, great economist Milton Friedman observed that to gain insight into the motivation of an individual or organization, look for the self-interest. So, where does the self-interest of regulators lie? Not necessarily in serving the public interest, alas, but in expanded responsibilities, bigger budgets and grander bureaucratic empires for themselves.

A corollary is that particularly when governmental pre-marketing approval of a product is required, greater health and safety are not synonymous with more stringent regulation. In fact, the net benefit to patients often suffers due to a systematic regulatory phenomenon – the asymmetry of outcomes from so-called Type I and Type II errors. A regulator can err by permitting something bad to happen (e.g., approving a harmful product, a Type I error) or by preventing something salubrious from becoming available (e.g., not approving a beneficial product, a Type II error).

The two types of error are, in effect, opposite sides of the same coin – too-aggressive attempts to avoid Type I errors makes regulators prone to Type II errors. Both outcomes are bad for patients, but the consequences for the regulator are very different. Type I errors are highly visible, causing the regulators to be attacked by the media and patient groups and to come to the attention of congressional overseers, but Type II errors are usually nonevents and elicit little attention, let alone outrage.

The FDA’s approval process for new drugs has long struggled with this Type I/Type II dichotomy. Consider, for example, the FDA’s approval in 1976 of the swine flu vaccine. That approval is generally perceived to have been a Type I error because, although the vaccine was effective at preventing influenza, it manifested a major side effect that was unknown at the time of approval and that resulted in 532 cases of paralysis, including 32 deaths, from Guillain-Barré syndrome, a progressive (and usually temporary) muscle paralysis. The mistaken approval had immediate consequences: The developers of the product and the regulators who allowed it to be marketed were excoriated and punished in the modern-day pillories of congressional hearings, television newsmagazines, and newspaper editorials. 

Regulators remember such occurrences and, thereafter, respond by being overly cautious, and the result is systematic delays in product approvals.

In the pursuit of avoiding Type 1 errors, the FDA has sometimes exceeded its legislative mandate. Regulators have concocted additional criteria for marketing approval of a new drug above and beyond the statutory requirements, which could inflict significant damage on both patients and pharmaceutical companies. For example, they have arbitrarily demanded that a new drug be superior to existing therapies, although the Food, Drug and Cosmetic Act requires only a demonstration of safety and efficacy. And Phase 4 (post-marketing) studies are now routine, whereas the FDA used to reserve them for rare situations, such as when there were subpopulations of patients for whom data were insufficient at the time of approval.

The impacts of FDA regulators’ self-serving actions range from the creation of disincentives to research and development to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.

Another egregious example of the impact of excessive risk-aversion is the sorry saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been marketed in Europe, Japan, Canada, and China. During the delay, more than 150,000 Americans died of IPF, many of whom could have benefited from the drug.

A particularly dubious policy is the FDA’s self-declared jurisdiction over “genetically engineered” animals, which virtually destroyed an entire, once-promising sector of biotechnology. The agency took more than 20 years to approve the first one – an obviously benign, fast-growing salmon – and then botched the five-year review of a single field trial of a genetically engineered mosquito to control the mosquitoes that transmit several viral diseases. (FDA finally conceded it didn’t have jurisdiction over it, and turfed it to the quagmire of the EPA.)

If we are to realize the kind of aggressive, innovation-promoting deregulation that FDA needs, the new commissioner will have to cut the fat and disrupt the agency’s built-in bias for overregulation. We’re not optimistic that Califf or any other Biden nominee will have the appetite for 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 Office of Biotechnology at the FDA and is the author of “To America’s Health: A Proposal to Reform the FDA.” Jeff Stier is a senior fellow at the Taxpayers Protection Alliance.

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1 comment

  • An excellent article. The unmentioned 100-Ton gorilla in the room is COVID. Specifically, the Type 1 & Type 2 Errors and conflicts of interest surrounding COVID vaccines and drugs. Both the vaccines, drugs and protocols unleashed upon the public; and the drugs, vaccines and protocols withheld and actively banned, banished or persecuted to the extent that even discussion is disallowed. Biden’s choice of FDA nominee reflects a deep-seated love and fatal attraction to bureaucratic blunders, inefficiencies and incompetence. It is probably expecting too much for the Senate to do anything more than rubber-stamp.

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