The FDA has problems -- Here are the qualities the next commissioner must have to fix them

The Food and Drug Administration (FDA) is the nation's most ubiquitous regulatory agency.  It oversees a vast array of medical and food products that account for 25 cents of every consumer dollar, with a value of over a trillion dollars annually.

And the agency has problems.

It’s too risk-averse, bureaucratically top-heavy, and dependent on policymaking that constitutes the “dark matter” of government – announcements, guidance documents, warning letters, speeches and so on, instead of formal rulemaking.

OPIOID CRISIS -- SINCE WHEN DOES THE GOVERNMENT WRITE PRESCRIPTIONS?

With the just-announced resignation of FDA Commissioner Dr. Scott Gottlieb, the White House and Health and Human Services Secretary Alex Azar will begin a search to replace him. We need someone who will deregulate aggressively in order to stimulate innovation, get more products on the market, and put downward pressure on drug prices.

The FDA is a favorite target of critics, who variously accuse regulators of excessive risk-aversion and delay of approvals, or of too cozy a relationship with the drug industry. Former FDA Commissioner Frank E. Young once characterized his agency as "a slow-moving target that bleeds profusely when hit."

Sen. Charles E. Grassley, R-Iowa, then-chairman of the Senate Finance Committee, chided the agency during a hearing, "The health and safety of the public must be the FDA's first and only concern." He is right, but particularly when governmental pre-marketing approval of a product is required, greater safety is not synonymous with more stringent regulation.

In fact, net benefit to patients often suffers 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 delayed side effects), or by preventing something good from becoming available (not approving a beneficial product such as the meningitis B vaccine that the FDA delayed for years). 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 to be investigated 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, let alone outrage.

If we are to balance drug safety, innovation in research and development, and the availability and price of new medicines, we must find a way to make regulators accountable for costly errors of all kinds.

Former FDA Commissioner Alexander Schmidt aptly summarized the regulator's conundrum: "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."

As a result, regulators make decisions defensively, so they tend to delay or reject new products of all sorts, from fat substitutes to vaccines and painkillers. That's bad for public health and for consumers' freedom to choose.

Congressional oversight is supposed to provide a check on regulators' performance, but rarely does it focus on their unnecessarily delaying product approvals. A premature or mistaken approval makes for more exciting hearings, with injured patients and their families paraded before the cameras.

If we are to balance drug safety, innovation in research and development, and the availability and price of new medicines, we must find a way to make regulators accountable for costly errors of all kinds.

The implicit contract between society and regulators demands greater accountability: We grant civil servants lifetime tenure, shielding them from the pressures of partisan politics and the threat of retaliation (which prevents the firing of even the most incompetent and ineffective employees), and in return, they are supposed to make decisions based solely on the public interest.

Alas, that is not always the case.

While he did a lot of chest-thumping on easier issues, Dr. Gottlieb shied away from or stumbled over many tough ones. The FDA’s current dysfunctional regulation of animals made with modern genetic engineering (see this and this), the war on e-cigarettes, and the permissiveness toward illegal claims by the organic food industry are good examples.

Several characteristics will be essential in Gottlieb’s replacement.

Superior management skills and experience. The agency's scope is so sweeping – encompassing cardiac pacemakers, x-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, genetically engineered animals, artificial sweeteners and fat substitutes – that a single person cannot be expected to master the body of science, medicine, pharmacology and engineering (to say nothing of the law and "regulatory science") involved. One must assume that the FDA's own professional staff can frame the issues and options; the function of the agency head, then, should be primarily to manage the far-flung empire and to make the final decision on difficult policy questions.

Unassailable integrity and honesty. The commissioner's decision-making must meld law, science, medicine and regulatory precedents, in a way that maximizes the public interest. The incumbent needs to earn the respect of those who have a stake in the FDA's policies and decisions – patient groups, individual consumers, drug companies – by means of candor and consistency.

Committed to regulatory reform. The FDA needs both to streamline existing regulatory procedures and requirements, and to work with Congress on new approaches that offer non-governmental alternatives to some of the agency's functions. The latter could include enhanced use of expert advisory committees, contracting out product reviews, reciprocity of approvals with certain foreign counterparts, and the creation of a mechanism like Underwriters Laboratories' certification of thousands of categories of products. In addition, FDA's senior and mid-level managers must be made more accountable for their decisions – especially those that delay the availability of new drugs, vaccines and medical devices to patients in need of them.

Distanced from politics. The FDA commissioner's job should not be awarded as a political plum, as are certain cabinet posts and ambassadorships. Politics should be banished insofar as that is possible, with the commissioner taking the heat for unpopular decisions.

American innovation and patients who need FDA-regulated products deserve nothing less.

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