The FDA Needs More Adult Supervision, Not More Independence Henry I. Miller
https://issuesinsights.com/2019/11/25/the
Academics and former agency heads have called for the Food and Drug Administration to become an independent agency, out from under the umbrella of the Department of Health and Human Services (HHS). Although the FDA has real problems, giving it more independence isn’t the solution.
The argument may sound compelling. “Partisan political interposition has grown increasingly worrisome” at the FDA, said three academics in an article in the journal Science. They continued: “As the sole arbiter standing between a new drug application and a potential public health calamity, the FDA can hardly afford to be buffeted by undue political interference,” and should, therefore, become an independent agency. A group of former heads of the agency made a similar recommendation in January.
Yet political meddling has been extremely rare in recent years, and the genuine calamities in which the FDA has been involved have been self-inflicted wounds that might have been avoided with more, not less, accountability and oversight.
The FDA is ubiquitous in Americans’ lives, regulating products that account for more than $1 trillion dollars annually — 25 cents of every consumer dollar. Its regulation provides some measure of reassurance and tangible benefits, to be sure, but it has massive costs, direct and indirect. For example, bringing a new drug to market costs, on average, more than $2.5 billion.
Regulation that is excessive actually costs lives, both directly by withholding life-saving products, and also by diverting societal resources to gratuitous regulatory compliance.
The late economist Milton Friedman observed that to gain insight into the motivation of an individual or organization, look for the self-interest. Alas, the self-interest of regulators lies not in serving the public interest, but in expanded responsibilities, bigger budgets and grander bureaucratic empires for themselves. Bureaucrats have perfected the art of achieving these goals, often at the expense of responsible governance.
Another incongruity is the widespread misconception that more-stringent regulation is synonymous with greater safety. The reality is that net benefit to patients is often compromised by the asymmetry of outcomes from the two types of mistakes that regulators can make. A regulator can commit an error by permitting something bad to happen (approving a harmful product such as a drug with side effects that are discovered only after the product is on the market), or by preventing something good from becoming available (i.e., not approving a beneficial product in a timely way). Both outcomes are bad for the public, but the consequences for the regulator are very different.
The first kind of error is highly visible, causing the regulators to be attacked by the media and patient groups, and investigations by Congress. But the second kind of error — keeping a potentially important product out of consumers’ hands — is usually a non-event, eliciting little attention.
As a result, regulators make decisions defensively, tending to delay or reject new products of all sorts, from cancer drugs to vaccines and painkillers. That’s bad for public health and for physicians’ and consumers’ freedom to choose among a variety of products.
Lawmakers’ Role
Congressional oversight is supposed to provide a check on regulators’ performance, but rarely does it focus on gratuitous delays in product approvals. A premature or mistaken approval makes for more exciting hearings, with injured patients and their families paraded before the cameras. There is no reason to expect that congressional oversight would be more conscientious if FDA were to become an independent agency.
The impacts of FDA regulators’ self-serving actions range from the creation of disincentives to research and development (and inflated costs for them) 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 patients died of IPF in the United States, many of whom could have benefited from the drug.
FDA also has authority over absence claims on food labels. While this isn’t an issue on the same life-or-death scale as drug approvals, it is certainly crucial for continuing innovation in the food supply. Inexplicably, for decades the FDA has been tolerating misleading food manufacturers’ “absence claims” — a label or other assertion that makes a meaningless distinction between their item and another. For example, the Non-GMO Project butterfly label is an absence claim. It’s on tens of thousands of products at the grocery store, even those that could never contain GMOs, such as orange juice (no GMO oranges) or salt (which is a mineral not obtained from organisms). “A statement may be false or misleading if,” says FDA’s Guidance for Industry, “if it suggests or implies that a food product or ingredient is safer, more nutritious, or otherwise has different attributes than other comparable foods because the food was not genetically engineered.”
Conversely, while the agency has been giving a pass to the kind of costly and misleading labeling described above, at times regulators have been over-zealous. In 2017, FDA sent a formal warning letter to a Massachusetts bakery for including “love” in its ingredient list. “‘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 said. This is a parody of responsible regulation.
In addition to these examples of FDA needing more adult supervision, three distinguished former federal officials have offered in the journal Health Affairs compelling procedural arguments against making FDA an independent agency. As an independent agency, they said, FDA would not be bound to the policies of the Department of Justice, potentially leading to inconsistent positions being taken by different parts of the government on issues that could include foreign policy.
Furthermore, they point out, applying a consistent approach to rulemaking as required by working within Health and Human Services and Office of Management and Budget strictures is a useful check on highly expensive regulation. “It’s also a way that Congress and the president can ensure consistency across government in the application of expertise in regulatory policy,” they said.
The need for adult supervision of regulators is implicit in humorist P.J. O’Rourke’s pithy observation, “Giving money and power to government is like giving whiskey and car keys to teenage boys.” Thus, what we need for FDA is not more independence and freedom from accountability but better management and more-conscientious oversight.
That is easier said than done, but there is a role both for Congress, which must demand greater perspicacity and discipline from regulators, and for the Department of Health and Human Services, which should restore to the HHS assistant secretary for health direct management responsibility for FDA’s performance.
Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. An FDA official for 15 years, he was the founding director of its Office of Biotechnology.
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