The hypocrisy of Big Pharma on mifepristone

Challenging a Texas court ruling vacating the FDA's authority was the right thing to do, but the industry has no problem ignoring science or skirting FDA rules when it suits its interests

Late yesterday afternoon, more than 400 pharmaceutical executives issued a scathing letter attacking the Trump-appointed judge’s decision invalidating the Food and Drug Administration’s approval of mifepristone, one of two drugs used for non-invasive abortions. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the letter said.

Their fears are justified. Many FDA-approved drugs have severe side effect profiles, including the risk of death. Virtually all cause minor harms, at least in some cases. The agency’s process for approving any drug or medical device relies on making the scientific determination that the benefits of a medical intervention outweighs its risks.

Judge Matthew Kacsmaryk’s ruling in favor of the anti-abortion advocates who brought suit in the Northern District of Texas federal court would put an end to such science-based decision making at the federal level. It would give judges and juries sitting in courtrooms the right to make regulatory decisions.

The impact of his ruling, if upheld by the Supreme Court, would affect a wide range of industries. While the drug industry in this case went to bat for its regulators, one can easily imagine numerous industries using this precedent to challenge environmental, safety, public health and worker protection regulations premised on a balance of risks and rewards.

It would also give the same right to public interest groups who favor greater regulation of business. If the anti-abortion movement can go court shopping in Texas, Public Citizen, the Sierra Club, the Center for Biological Diversity and similar groups can do the same in federal courts where liberal judges hold sway, like in Washington where last week another federal judge upheld the FDA’s approval of mifepristone.

Progressive challenges to regulatory decisions usually fail because federal courts have historically given federal agencies the right to make those decisions. Their powers are not unlimited. Congress sets broad goals (clean air and water; safe products; workplace safety; fair competition) and gives the agencies specific rules for how to achieve those goals like the use of scientific analysis; the balancing of risk and reward; and sometimes taking cost into consideration.

Public interest groups also charge that industry dominates the regulatory process through the use of scientific studies conducted by industry-funded scientists. The courts invariably ignore those complaints.

So the backstory to the mifepristone case is that Big Pharma is carrying water for the entire corporate community. In protecting the integrity of the regulatory process, it is also protecting its control over that process — what economists call agency capture.

One need look no farther than the FDA’s recent decision in the case of Aduhelm, the Alzheimer’s drug that an FDA scientific advisory panel in November 2020 overwhelmingly rejected as ineffective. At least five members of that committee later resigned from the advisory panel with one calling it “the worst approval decision that the F.D.A. has made.”

I didn’t hear any complaints from Big Pharma when top officials at FDA overruled its outside advisors and approved the drug. After Biogen, the drug’s manufacturer, set a pricetag of $56,000 a year for Aduhelm, many insurers have set limits on who can get the drug. Medicare said it will only pay for seniors on the drug if they are enrolled in a clinical trial.

So while I gladly welcome Big Pharma’s legal and political muscle in the fight to protect the regulatory process, I have no illusions about its motivations. It has been noticeably absent in the fight to protect a woman’s right to abortion and other reproductive health rights in conservative states that are moving rapidly to criminalize both a woman’s right to choose and the use of their products in what is the safest method of abortion and post-miscarriage care.

While we’re on the subject of hypocrisy, I saw that a spokesman for Pfizer told the New York Times that the company did not support off-label use of any of its medicines. Its misoprostol, the other drug used in combination with misepristone during a chemically-induced abortion, is not approved for that use. It is prescribed off-label.

Of course, Pfizer had to say that. More than a decade ago, Pfizer signed a corporate integrity agreement with the U.S. Department of Justice after pleading guilty and paying a $1 billion fine for the illegal off-label marketing of four of its drugs.