Opinion | The Supreme Court should be wary of revoking an abortion medication’s approval

Jane E. Henney understands this well. In 2000, she was the FDA commissioner who gave approval for use of mifepristone. Though the drug had already been used for years in a number of countries, including France, Britain and Sweden, this was the first time medication abortions would be legally allowed in the United States.

Henney, an oncologist by training, knew her decision would be contentious, but, as she told me in an interview, “The FDA review and approval process is one in which politics are not taken into consideration.” Her team reviewing the application were experts who used the same standard, thorough and evidence-based process they always followed.

After the FDA received the application for mifepristone in 1996, it convened a committee of external advisers later that year. Over the next four years, the FDA underwent three rounds of rigorous reviews. Ultimately, external and internal experts recommended approval, citing dozens of safety studies, including one that involved 16,000 participants.

Henney disputes the statement by the Texas federal judge who sided with antiabortion activists this month in ruling that the FDA didn’t follow standard procedure in assessing mifepristone’s risks.

“There was nothing wrong with the process,” she said. “In fact, it was reviewed by the Government Accountability Office in 2008. What they found was the normal process was followed; it was done comprehensively; and there were no deviations.”

The ruling makes even less sense because, as Henney said, “it became clear that the safety profile is even better than when we gave approval.” Over the past two decades, more than 4 million women have received mifepristone for their abortion care, and more than 100 peer-reviewed research publications have affirmed its safety. More than half of pregnancy terminations are now medication abortions, which are safer and avoid the logistical barriers of surgical procedures.

If the Supreme Court sides with the lower-court judge and revokes authorization for mifepristone, it would force women to choose other methods of pregnancy termination. The current protocol for medication abortions is mifepristone combined with another drug, misoprostol. Misoprostol could be used alone, but it causes more side effects, such as longer duration of cramping and bleeding. And the confusion around access to mifepristone could delay care for some women, forcing them to seek surgical procedures or even look for mifepristone through illegal sources.

None of these consequences would, as antiabortion activists claim, protect the health of women; rather, restricting a safe method of early abortion care would endanger women’s health. This is what I’ve maintained for years, including when I was president of Planned Parenthood: Banning abortion won’t stop abortions, but it would stop safe and legal abortions.

Even those ambivalent about reproductive rights should worry about the ruling’s implications because of the precedent it would set in undermining the FDA’s authority.

“This would be the first revocation of an FDA-approved product by the courts,” Henney said. “The people who work at the agency, who are experts in their field, do their work with a high degree of professionalism and integrity. To have that be minimized or negated in some way — it troubles me a great deal.”

This concern has resonated throughout the pharmaceutical industry, whose main trade group, the Pharmaceutical Research and Manufacturers of America, wrote in an amicus brief that the ruling threatens to “allow limitless litigation aimed at overturning FDA’s expert drug approval decisions.” Dozens of pharmaceutical executives also filed a brief with the court that warned that the decision “will shatter FDA’s gold standard of scientific safety and efficacy review.”

“I am very respectful of the court’s expertise in many areas, but it is not in determining the risk and benefit of specific drugs,” Henney said. “We’re seeing so many in the pharmaceutical industry deeply disturbed because all their work in developing drugs could be overturned at the whim of a court ruling.”

In addition, an FDA approval gives “not only credibility with the public but also opens worldwide markets,” she said. “Other regulatory bodies recognize the gold standard that the FDA has always been.” Undermining FDA’s authority could upend the United States’ long-held leadership in drug development, with ripple effects on access to therapeutics in other countries.

To me, the question before the Supreme Court hinges on this point: Does it recognize the authority that Congress entrusted the FDA’s scientists and clinicians to represent the public’s interest and approve drugs based on evidence and long-established procedures, or not? Mifepristone must be treated like all other pharmaceutical products reviewed by the FDA, just as reproductive care must be treated like any other aspects of health care.