A District Judge in a Den of Robbers
Texas’s mifepristone ruling hits both abortion and drug industries in one swing.
The pharmaceutical industry is mad. Senior executives of more than 250 pharmaceutical and biotech companies, including the chief executives of both Pfizer and Biogen, responded to a recent ruling by a federal judge with a fuming open letter, saying the ruling “has set a precedent for diminishing F.D.A.’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”
The ruling in question was one out of a district court in Texas last week, which invalidated the Food and Drug Administration’s approval of mifepristone, a drug used to take the life of an unborn child in the early stages of pregnancy, and the tool used to perform more than half of the abortions in the United States today. The ban was set to take effect April 14, but the drug will remain available for now, with some restrictions, after a federal appeals court granted the Biden administration’s emergency request to keep the pill on the market until the issue is settled by a higher court.
In the letter, the executives pressed that pharmaceutical companies rely on the FDA’s “autonomy” to bring products to market, autonomy that is threatened by the judicial system’s involvement. “If courts can overturn drug approvals without regard for science or evidence,” the letter said, “...any medicine is at risk for the same outcome as mifepristone.” Putting aside the intentional checks and balances of our system of government, one of which is the role of the judicial branch in keeping the executive branch in line, it is an odd position for the executives to take, and one that only gets odder the longer you look at it.
The FDA’s history is anything but autonomous: The influence of the pharmaceutical industry is so obvious as to hardly need stating. These executives may know this better than anyone, but they also have a vested interest in making sure you don’t. Still, even if we hadn’t seen the FDA played like a harp by pharma executives before, a functioning regulatory agency is by definition a hurdle in the path of drug makers. Why would they rush to defend it? Why indeed, unless their own pathways to success were concurrent with the agency’s unchecked power.
The FDA exists, in theory, to put up good, firm speed bumps between drug manufacturers and the public. This is not because all pharmaceutical executives are mad scientists or greedy by nature, but because, as Dr. John Abramson of Harvard Medical School recently told an audience at Hillsdale College, “biomedical products are not directly-experienced goods like bread, meat, and beer. They are what economists call ‘credence goods’—goods that can’t be evaluated directly by the purchaser. Rather, consumers must rely on the evaluation of experts. And with prescription drugs, the manufacturers have a monopoly on the information.”
Mifeprex, the brand name version of mifepristone, is manufactured by Danco Laboratories, and was approved for use in chemical abortions by the FDA in 2000. In 2019, GenBioPro appeared as the first biopharma company to market generic mifepristone with FDA approval, marketing the abortifacient as its one and only drug. Though Danco’s patent on the drug had expired years earlier in 2004, other companies had hesitated to market it, likely in part due to the contested nature of its original FDA approval in 2000. As a Government Accountability Office paper from 2008 reports, “critics have questioned aspects of the Mifeprex approval process.” Most glaring is the fact that it was legalized via a subsection of the agency’s rules that governs serious or life-threatening illnesses—of which pregnancy, whatever your creed, could not be considered one. Use of Mifeprex had also, the report notes, resulted in the deaths of several women.
Mifepristone ends a pregnancy by blocking progesterone, the hormone essential to the survival of a child in utero. It is often prescribed in tandem with another drug, misoprostol. The latter is produced under the brand name Cytotec, by Pfizer. While Cytotec is technically only approved by the FDA to treat stomach ulcers, it is prescribed with the progesterone blocker because its side effects include premature labor, miscarriage, and birth defects. Together, the two pills are 99 percent effective, but alone, misoprostol is still 88 percent effective at ending the life of an unborn child. Several states, including Massachusetts and New York, have already announced they will begin to stockpile it since the Texas ruling.
While Pfizer’s Cytotec is not technically in question here, it is clear enough to these executives that the Texas ruling births the potential for more serious reigning of the FDA’s near-unchecked power. What is at stake is not just mifepristone, or even the market for complimentary drugs like misoprostol, as, like donuts and coffee, the two tend to sell together.
What is at stake is—as the executives themselves inadvertently admit—a whole host of drugs on shaky legal footing, as well as decisions by unelected bureaucrats made with more regard for the success of the industry than the health of the American people. It is the ability to speed a new painkiller through a cumbersome approval process in mere months, because you are friends with the regulator; it is the borderline rubber stamp approval for the novel vaccines you create, not to mention the official recommendations that they be taken by every American over the age of 6 months.
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These things are at stake because one branch of the federal government has overstepped its bounds and put politics before science—not the judicial branch, as many in the biopharma industry would like you to believe, but the executive. It is the curbing of their king-makers that has these biopharma executives protesting so much. Even before the federal court approved the Biden administration’s emergency request, FDA leadership announced its intentions to ignore the ruling, in an attempt to strong arm the law out of the picture.
But there is something else at stake here, too: The lives of unborn babies, and those of several of their mothers. When pitted against the livelihoods of the chiefs of Pfizer, GenBioPro, and much of the drug industry, it is safe to say these lives are not the primary concern. But when pitted against the drug industry in tandem with the political muscle of the abortion industry, they are so far from being a concern that they have become irrelevant.
The debate is no longer about health, or life, or even science, but power. A Texas judge just threatened that power, smashing the first of thousands of links between the drug peddlers and the federal agency intended to restrain them. We should not imagine that those tentacles will not do everything in their power to rejoin.