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Abortion Pill Opponents Seize New Chance to Target FDA Approval

Nov. 23, 2022, 10:25 AM

A Christian advocacy group’s first-of-its kind lawsuit before a Trump-appointed Texas judge poses the greatest legal threat in years to access to abortion pills in America.

The lawsuit Alliance Defending Freedom filed Friday claims the Food and Drug Administration exceeded its authority when it used an accelerated process typically reserved for serious or life-threatening illnesses to approve mifepristone, a drug that coupled with another can be used to end a pregnancy within the first 10 weeks.

Since that decision in 2000, the use of abortion pills has steadily climbed among medical providers. It accounted for 54% of all US abortions two years ago, according to the Guttmacher Institute.

The ADF filed its complaint in federal court in Amarillo, where the only district judge is Matthew Kacsmaryk, who’s written critically of the constitutional right to same-sex marriage and whose past rulings included one rejecting explicit health protections for LGBTQ people.

Legal observers say the case shows how the Supreme Court’s decision in June to overturn Roe v. Wade has opened the door for conservative groups to challenge longstanding scientific authorities as a means to end abortion nationwide.

“This is a lawsuit that should not get anywhere, but that doesn’t mean it won’t get anywhere,” said Wendy Parmet, a professor of law and health policy at Northeastern University.

The FDA’s authority to regulate drugs is established, she said, but decisions from the high court have created “radical instability” in the law. “And when you have radical instability, anybody’s ability to predict anything is questionable.”

Record of Success

Alliance Defending Freedom is a legal powerhouse known for Supreme Court victories protecting a Christian baker who refused to make a wedding cake for an LGBTQ couple; allowing employers to deny workers health-care coverage for contraceptives; and safeguarding anti-abortion pregnancy centers from having to distribute information on abortion.

The group also worked with Mississippi officials in drafting and defending its state abortion law in Dobbs v. Jackson Women’s Health Organization—the case this year that overturned decades-long precedent of a constitutional right to abortion.

ADF is currently representing doctors and medical associations in a lawsuit against the Biden administration’s nationwide efforts to ensure access to abortions in medical emergencies. That group clinched an early win from a different division of the same district court in Texas.

Julie Blake, the senior counsel for ADF, said the medical groups her organization represents in the case against the FDA have been fighting over the abortion medication since as early as 2002, when they filed a citizen petition seeking to halt the drug’s approval.

“The FDA should never have approved these drugs in the first place,” she said.

In Kacsmaryk, they are likely to find a sympathetic ear. Before his nomination by President Donald Trump in 2017, he was deputy general counsel to the First Liberty Institute, a Texas-based conservative legal advocate, when it won a group of Christian ministries’ challenge to a contraception coverage mandate from the Department of Health and Human Services.

Given that resume, Kacsmaryk will most likely side with the ADF plaintiffs, said Greer Donley, associate professor at the University of Pittsburgh Law School.

The alliance almost certainly knew that when it filed the complaint in a court where Kacsmaryk gets almost every case. Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University, described the case as “the height of forum shopping — trying to pick your judge to get a favorable ruling.”

Any appeal of a decision by Kacsmaryk would head to the US Court of Appeals for the Fifth Circuit, which has 12 judges appointed by Republican presidents out of 16 active judges. From there, the next step is the Supreme Court that threw out Roe.

Legal Strategy

The ADF suit argues the FDA used accelerated approval regulations to improperly characterize pregnancy as an illness.

Those regulations, known as Subpart H, allow the agency to fast-track the approval of a drug or apply certain restrictions to ensure its safety. The provisions are supposed to apply to drugs that “are intended to treat serious or life-threatening illnesses” and provide a substantial benefit over existing treatments.

A 2008 Government Accountability Office report on the FDA’s approval and oversight of mifepristone, known by the brand name Mifeprex, found that the agency properly used its Subpart H authority to impose dispensing restrictions on the abortion pill to defend its safety, including that only authorized prescribers dispense the drug with informed patient consent. It found the FDA didn’t use Subpart H to accelerate the drug’s approval.

The GAO also supported the FDA’s argument that “the termination of an unwanted pregnancy is a serious condition, and that the drug provided a meaningful therapeutic benefit over existing therapies by allowing patients to avoid the procedure required with surgical termination of pregnancy.”

At the time of FDA approval, mifepristone had already been cleared for use in other countries, including France, the UK, and Sweden.

Mifepristone and misoprostol, the drug it is coupled with, are often more accessible than surgical procedures in states that ban abortion because the FDA allows them to be prescribed via telehealth. Studies show mifepristone is safer and sends fewer people to the ER than Tylenol and Viagra.

The American College of Obstetrics and Gynecology has defended the safety of mifepristone for use in terminating early pregnancies. The FDA announced in December 2021 that a full review of existing safety and efficacy data supported permanently removing the requirement that patients visit a provider in person to get mifepristone.

The FDA declined to comment on ADF’s lawsuit.

Susan Wood, former assistant commissioner for women’s health at the FDA, said the ADF’s assertions about the misuse of Subpart H and the consequences of medicated abortions are flawed, but said they aren’t concerned about being accurate.

“It doesn’t really matter about this particular product and the particular evidence about safety and efficacy,” said Wood, now director of the Jacobs Institute of Women’s Health at the George Washington University. “They are working to end access to medication abortion, no matter what the data on safety and efficacy really is.”

Threat to Agency Authority

The plaintiffs have asked Kacsmaryk to immediately enjoin the FDA’s approval of the drug while the case proceeds.

“Hopefully that means we’re looking at weeks or months to get to a decision as opposed to the years that litigation sometimes can take,” Blake said.

Either way, the decision could have lasting implications for the agency’s authority.

The lawsuit’s outcome “goes well beyond abortion,” said Gostin, the health law expert at Georgetown. The FDA could have a harder time regulating “any controversial medication” like opioids or injection equipment if the lawsuit were to prevail, he said.

Courts have historically deferred to the FDA on “issues of science versus law,” said Delia Deschaine, an attorney at Epstein Becker & Green specializing in FDA regulations.

But given the Dobbs decision and the court’s open skepticism of the deference given to administrative agencies, she said, “it’s safe to say that all bets are off on how this case ultimately will be decided.”

To contact the reporters on this story: Allie Reed in Washington at areed@bloombergindustry.com; Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: John P. Martin at jmartin@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com