Should the U.S. Food and Drug Administration, which currently resides organizationally within the Department of Health and Human Services, become an independent agency? A few academics recently argued that “partisan political interposition has grown increasingly worrisome. 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 have made a similar recommendation.

In fact, political meddling at the FDA has been extremely rare in recent years, in no small part because of the agency’s 17,000-plus employees, more than 99.9% enjoy civil service protection from political influence or retaliation. And although there have been some real problems with the formulation of policies and their implementation, they have been largely self-inflicted wounds that might have been avoided with more, not less, oversight.

Regulators and risk / The FDA is ubiquitous in Americans’ lives, regulating products that account for more than $1 trillion annually—25¢ of every consumer dollar. Regulation of those goods provides some measure of reassurance and tangible benefits, to be sure, but it has massive costs, direct and indirect. Regulation that is wrong-headed or that merely fails to be cost-effective actually costs lives, both directly by withholding life-saving products and indirectly by diverting societal resources to gratuitous regulatory compliance.

There is widespread belief among the public and their representatives that more-stringent regulation is synonymous with greater public well-being. In fact, net benefit to patients is often compromised because of a regulatory anomaly: 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 like a drug with unrecognized side effects), or by preventing something good from becoming available (not approving a beneficial product in a timely way). Both outcomes are bad for the public, but their 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 investigated by Congress. 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 unnecessarily 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.

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 the FDA were to become an independent agency.

These perverse incentives for FDA regulators yield a host of negative consequences for public welfare, ranging from disincentives for product research and development (and inflated costs for them), to significant threats to public health. The detrimental effects of FDA delays in approving certain new drugs already available in other industrialized countries are well documented.

An example is the long delay before the FDA’s 2015 approval of Fluad, a flu vaccine that contains an adjuvant that boosts immune response. It is used primarily in the elderly, whose immune response to flu vaccines typically is poor. According to the Centers for Disease Control,

It has been estimated that between 71 percent and 85 percent of seasonal flu-related deaths have occurred in people 65 years and older and between 54 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people in that age group.

Fluad had been used in Italy since 1997 and approved in more than three dozen countries. The 18-year delay in availability in the United States undoubtedly resulted in many avoidable hospitalizations and deaths. Another example was the delay in approval of a much-needed meningitis B vaccine.

Yet another egregious example of the harm from the FDA’s excessive risk-aversion is the drug pirfenidone. It is 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.

These examples illustrate the endemic problem at “gatekeeper” regulatory agencies, which must grant an affirmative approval before a product can be legally marketed. Their timidity can be lethal.

Labeling and advertising / The FDA also has authority over the accuracy and integrity of food labeling. Although this isn’t generally an issue on the same life-or-death scale as drug approvals, it is important to informing consumers’ choices in a free market. It also offers examples of regulators’ distorted priorities and poor judgement.

Consider one example: In 2017, the 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 stated.

But while the FDA finds time to police inconsequential violations at small bakeries, it has been giving a pass for decades to the $47-billion-a-year organic industry’s blatantly false and deceptive advertising claims. Consider the Whole Foods website, which explicitly claims that organic foods are grown “without toxic or persistent pesticides.” In fact, organic farmers rely on both synthetic and natural pesticides to grow their crops, just as conventional farmers do, and organic products can contain residues of numerous synthetic as well as natural chemicals.

In addition to such blatant untruths, food marketers are masters at subtly misleading consumers. A favored technique is the “absence claim”: asserting a meaningless distinction between products in order to make theirs seem superior. The feds would never allow an orange juice producer to label its product “fat free,” for example, because that would imply the product is healthier than other orange juice when, in fact, no orange juice contains fat. Generally, the FDA comes down hard on such behavior. But some get a pass: Tropicana labels its orange juice “Non-GMO Project Verified” and Hunt’s labels its canned crushed tomatoes “non-GMO,” even though there are no genetically engineered oranges or tomatoes on the market. In fact, absence claims about GMOs are never enforced: I was unable to find a single FDA warning letter or other enforcement action against deceptive “non-GMO” labeling.

The Non-GMO Project’s butterfly label appears on more than 55,000 organic and nonorganic products on supermarket shelves today, many of which have no GMO counterpart or couldn’t possibly contain GMOs. The clear purpose of these labels, as one peer-reviewed academic study found, is to “stigmatize food produced with conventional processes even when there is no scientific evidence that they cause harm, or even that it is compositionally any different.” The labels and anti-genetic-engineering propaganda are effective: another study found nearly half of consumers avoid GMO-labeled foods.

The FDA’s years-long inaction is all the more surprising inasmuch as they published explicit guidance on this issue in 2015:

Another example of a statement in food labeling that may be false or misleading could be the statement “None of the ingredients in this food is genetically engineered” on a food where some of the ingredients are incapable of being produced through genetic engineering (e.g., salt).

That FDA guidance went further, explaining that GMO absence claims can also be “false and misleading” if they imply that a certain food “is safer, more nutritious, or otherwise has different attributes than other comparable foods because the food was not genetically engineered.” But this (in addition to violating the “standard of presence” criterion) is exactly what the Non-GMO Project’s butterfly labels are all about. Its website, considered by the FDA to be a part of its labeling, describes certain foods as being at “high risk” of “GMO contamination.”

Fortunately, the regulatory landscape for labeling may be changing. Guidance issued in March indicates that the FDA recognizes these widespread deceptive practices. It remains to be seen whether regulators will follow up this guidance with long-overdue enforcement action or continue to give a pass to the politically favored organic industry.

Greater accountability needed / Earlier this year, a blog post on Health Affairs’ website by three distinguished former federal officials raised valid objections to making the FDA an independent agency. Quoting from their post:

  • The [U.S.] president’s program—which is conceptualized and implemented through accountability to cabinet secretaries and the [Office of Management and Budget]—is important for directing the activities of the FDA. For example, presidential initiatives to lower drug prices bear on the rapid approval of generics but also on how such products are purchased by Medicare and Medicaid. In addition, policies to address the opioid crisis draw on the expertise and regulatory structure of the FDA, as well as many other federal agencies—inside and outside of HHS. FDA coordination and expertise [are] invaluable in formulating this program and can best be incorporated when the FDA is part of the vibrant debate that goes on among HHS operating divisions.
  • An independent FDA would be able to represent its views in litigation without reference to well-established policies of the Department of Justice (DOJ). (Agencies within HHS, on the other hand, must follow DOJ policies.) Failure of the FDA to follow the DOJ’s central rules on matters such as jurisdiction, standing, immunity, and remedies could leave the court system with inconsistent positions being taken by different parts of the US government. This phenomenon is also potentially present if the FDA was to adopt a different view on points related to foreign policy than the Departments of Defense or State, or the US Trade Representative.
  • There are benefits to be secured from working within the HHS and OMB structures to make sure that the tools and techniques of economic analysis are consistently applied to rulemaking involving similar matters. The OMB’s Office of Information and Regulatory Affairs may seem cumbersome to the leader of an HHS operating division, but it has consistently been a highly useful check on the risks of excessively 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

The post’s authors were charitable enough not to mention that the FDA has had some terrible commissioners over the last three decades. Even the meager existing oversight and management of them has been something of a check on their worst inclinations.

What the FDA needs is not more independence and freedom from accountability, but better management and more conscientious oversight. There is a role both for Congress, which must demand greater perspicacity and discipline from regulators, and for the HHS, which should restore responsibility for the FDA’s performance to the assistant secretary for health, who once had authority over the agency.