A federal judge in Texas has taken a shocking and irresponsible action:invalidating the Food and Drug Administration’s approval of mifepristone, a medication used safely by hundreds of thousands of women each year to help terminate pregnancies as part of a two-pill regimen. For what appears to be the first time, a court has invalidated an agency drug approval — an approval that was based on extensive review of scientific evidence, earned the unanimous support of outside experts and retains, after two decades, the full backing of major professional medical organizations.
The decision is so stunning that it is reasonable to ask whether courts should have any role in reviewing the F.D.A.’s scientific decision-making at all. In fact, judges do have an important job: protecting the ability of the agency to use science and expert judgment to support the health of the American people. The Texas decision is a perversion of this role and, by undermining the F.D.A., represents a threat to the safety of millions of Americans.
There’s a name for the day of the week when the F.D.A. finds itself in court: Monday. Also, Tuesday, Wednesday, Thursday and Friday. Sometimes the weekends, too. The agency’s large stable of dedicated attorneys defends its actions on a multitude of issues. These include routine administrative matters such as whether the agency moved too fast or too slow on a generic drug approval or whether the agency has missed regulatory deadlines.
More consequential cases challenge whether the agency has the authority under statutes or the Constitution to address serious threats. For example, the Supreme Court struck down the agency’s initial attempt to regulate the marketing of tobacco products, leading Congress to later pass legislation permitting the agency to move forward. To the chagrin of many public health advocates, an expanding constitutional doctrine of corporate speech has led courts to limit the actions that the F.D.A. can take to protect the public.
And then there are those cases that seek to overturn actual regulatory decisions, which may be brought by advocacy groups, regulated companies or other affected parties. In determining whether the agency has been “arbitrary and capricious,” the standard of review, courts have long respected the judgments of the F.D.A.’s experts, especially those that are in line with expert advice and the consensus of leading medical organizations. This respect has led courts in rare instances to intervene when inappropriate political interference has disrupted the agency’s normal processes.
Example A is Plan B. In 2009, a federal judge ordered the F.D.A. to make emergency contraception available over the counter to 17-year-olds. The decision came after investigations found that the leadership of the F.D.A. during the Bush administration deviated from normal procedures when it overruled the decisions of multiple staff scientists, the views of leading medical associations and the vote of advisory committees, all of which were supportive of making the product available without a prescription to people of all ages.
By 2011, the agency’s scientists had again determined that it was appropriate to permit emergency contraception to be sold over the counter without age restrictions. This time, the F.D.A. commissioner appointed by President Barack Obama supported the scientists’ position, publicly explaining that it was based on scientific findings, expert advice, and data from well-designed studies. Yet the secretary of health and human services overruled the agency and blocked approval for all ages on the basis of her own review of the evidence, a decision endorsed by the president himself.
Again, the matter headed to court. The judge found that the secretary’s decision was “obviously political,” and cited expert testimony stating that the F.D.A.’s scientific decisions shouldn’t “bend to political winds.” The court ordered the F.D.A. to make emergency contraception available over the counter without age restrictions.
Political attempts to interfere in F.D.A.’s decision making are rare, but dangerous. During the Trump administration, concerns over political interference at the F.D.A. flared up during in the Covid-19 pandemic. The White House reportedly pressured the agency to support ineffective treatments and authorize vaccines before key data on safety had been gathered. Overruling agency scientists could have led to a court battle, with the judiciary needing to step in to preserve the agency’s authority and the trust of the public.
Now, growing ideological polarization, reflected in the Texas decision’s embrace of extreme language about abortion and health, poses new risks to the F.D.A.’s integrity. The Federal Food, Drug, and Cosmetic Act requires the F.D.A. to approve medications on the basis of “substantial evidence.” Trust in the agency’s work rests on the idea that decisions that affect a nation are based on facts, not ideology or influence.
Courts should protect this principle. Were a future administration to attempt to evade these requirements, such as by withdrawing medications that have been appropriately studied and approved, courts should strike it down. Such a threat of legal action may have kept the Bush administration from reconsidering the approval of mifepristone back in the early 2000s. Courts should also step in, as they have done in the past, as states like Wyoming try to outlaw approved drugs.
The scientific and regulatory excellence of the F.D.A. is a point of national pride. Because of its independent, thorough and expert reviews of data, the agency remains the international gold standard for approving medications. Confidence that the F.D.A. can do its work is essential for clinicians and patients, who routinely depend on the agency’s decision making on matters of life and death. It is also necessary for companies and their investors to develop important new therapies for devastating conditions. If judges can interfere with legitimate and well-supported F.D.A. action, there is no reason to believe that the consequences will be limited to abortion medications.
Courts can protect the work of F.D.A., or they can destroy it. In issuing an order to keep mifepristone on the market in certain states, a federal judge in Washington State is supporting the many millions of Americans who depend on the F.D.A.’s scientific decisions. The Supreme Court will soon have to decide which side it is on.
Dr. Sharfstein is a professor of the practice at the Bloomberg School of Public Health at Johns Hopkins. He was principal deputy commissioner of the Food and Drug Administration from 2009 to 2011.
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