Why Big Pharma sees the abortion drug legal fight as a grave business risk
Kaelan Deese
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One year after the nation learned of the Supreme Court‘s intent to peel back federal protections for abortions via a leaked draft opinion, a new legal fight over the approval of a common abortion drug has ignited condemnation from nearly every corner of the pharmaceutical industry.
In the span of a year, the Supreme Court’s overturning of Roe v. Wade has ushered in a new era of litigation in the anti-abortion movement that’s being spearheaded by doctors challenging the Food and Drug Administration‘s “accelerated approval” regimen that allowed the 2000 approval of a common abortion drug known as mifepristone.
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“There is a real irony here,” Case Western Reserve University professor Jessie Hill said, noting the Dobbs v. Jackson Women’s Health Organization opinion may have suggested an “idealized notion that overturning Roe v. Wade would mean the federal courts got out of deciding issues about abortion and that states would sort of reach their own solutions.
“I think that has been proven to be anything but true. It’s just the opposite,” Hill, whose teaching focuses on constitutional law and reproductive rights, told the Washington Examiner.
Last month, executives from more than 400 biotech and pharmaceutical industry companies signed a letter calling for the reversal of U.S. District Judge Matthew Kacsmaryk’s April 7 ruling that would have ended the FDA’s long-standing mifepristone approval. That decision quickly rose to the Supreme Court shortly before the justices blocked his decision from taking effect and returned it to the U.S. Court of Appeals for the 5th Circuit, where a three-judge panel will hear arguments on May 17 over the case’s merits.
Notably, most of the pharmaceutical signatories on briefs against the ruling are not involved in reproductive health, revealing that their interest in protesting the decision is less to do with their stance on reproductive health and more to do with maintaining the status quo for drug approvals.
“Although Big Pharma is not exactly a bastion of liberal progressivism … I think they see the real danger of this precedent,” Hill said.
Meanwhile, telemedicine legal experts such as Bethany Corbin told the Washington Examiner that there’s a generalized “fear” in the industry about what types of drugs could be subjected to legal scrutiny if Kacsmaryk’s full decision is upheld.
“In administrative law, there’s this general philosophy you defer to the federal agency that has the scientific knowledge and expertise,” Corbin said, adding that even a partial upholding of Kacsmaryk’s ruling could jeopardize other FDA-approved drugs. Some experts have suggested litigants could go after the pill commonly taken in tandem with mifepristone, a drug known as misoprostol.
While abortion proponents warn a superior court’s full embrace of Kacsmaryk’s ruling threatens to blockade abortion access even in states where such procedures are legal, experts say pharmaceutical companies are voicing opposition to the ruling largely due to the billions of dollars at stake if the FDA’s drug approval powers are subdued.
“Since the amount of money involved in getting a drug from point A onto a shelf or into the pharmacy is millions and millions and millions of dollars, throwing that up in the air is really problematic,” political analyst John Ellis told the Washington Examiner.
Doctors against abortion practices that sued over the FDA’s approval are represented by the Alliance Defending Freedom, a legal firm that was pivotal in overturning Roe through its defense of Mississippi’s 15-week abortion law.
The 5th Circuit already issued a ruling on April 12 that allowed mifepristone to remain on the market. However, it allowed parts of Kacsmaryk’s ruling to stand, such as strict conditions that block its use beyond seven weeks of pregnancy and blocks on its distribution by mail.
Hill suggested the May 17 oral arguments in the 5th Circuit will likely focus on a 150-year-old law, the Comstock Act, which was cited in the district judge’s ruling as one of the basis to block the FDA’s approval of the drug.
The decades-old law was intended to ban the mailing of contraceptives, pornography, and other drugs that induce abortions. The 5th Circuit initially refused to interpret whether the Comstock Act prohibits the mailing of mifepristone, given that there was uncertainty regarding the merits of the case.
“It’s a federal criminal law,” Hill said, noting that it would require the executive branch to enforce it and that the “Biden administration is not going to enforce it.”
Hill said she believes abortion opponents litigating the FDA keep citing the Comstock Act to present the idea that “this law should have some impact on other laws or on people’s behavior.”
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She also said that the interpretation of the Comstock Act could change in a future Republican administration.
“So, it does still matter, even though it is not currently enforced,” Hill added.