The country's largest manufacturer of abortion drugs is walking into the first major legal battle over President Trump's second term abortion.
The company's Genbiopro asked a Texas court on Tuesday to add it to the list of defendants in a lawsuit filed by three Republican attorney generals in October. The move was a key offensive action against issues seen as pioneering in the fight over access to abortion.
The lawsuit was filed by the state attorney generals in Missouri, Idaho and Kansas, and calls on federal courts to reverse a series of Food and Drug Administration regulations that have significantly expanded access to abortion drug Mifepristone.
Under the Biden administration, the Justice Department defended agency rules and FDA drug approval 25 years ago. However, many abortion rights advocates expect the Trump administration to refuse to defend the agency, effectively monitoring it with the state attorney general and using the case to restrict access.
If the judge grants Genbiopro's request, the operation allows the company to lead the defense of Mifepristone. The company is represented by Democracy Forward, a legal nonprofit that has filed more than a dozen lawsuits and has won multiple court orders against the Trump administration.
“The basis for these extreme politician arguments is purely political, not based on scientific evidence,” says Sky Perryman, president and CEO of Democratic Forward. “The threat this case poses to abortion access nationwide cannot be kept modest.”
Abortion medications are prescribed from 12 weeks from pregnancy and are used in nearly two-thirds of abortions in the United States. In states where abortions are criminalised or severely restricted, mail-order drugs have become the central way to receive procedures.
The Supreme Court says that health care providers in states where abortion is legal have sent more than 10,000 abortion drugs to patients in those states per month, as the DOBBS v. Jackson Women's Health Agency excluded the constitutional rights to abortion in the 2022 case.
Opponents of abortion have asked the administration to roll back rules that allow tablets to be prescribed by telehealth appointment and sent by mail. They argue that face-to-face medical visits are necessary to protect patients. Such efforts are part of their mission to end all abortions. Over 100 scientific studies conducted over decades have found that pills are safe and rarely cause serious complications.
Genbiopro, which produces abortion drugs only, controls about two-thirds of the drug market. Danko Institute, the only other mifepristone maker in the country, has already been appointed defendant in the lawsuit.
“We continue to be concerned about extremists and special interest attempts to undermine U.S. Food and Drug Administration regulators,” said Evan Masingill, CEO of Genbiopro. “Everyone has the right to access safe, affordable evidence-based health care. Genbiopro remains committed to using all legal and regulatory tools to protect Mifepristone, millions of patients and providers across the country.”
It remains unclear whether Trump will take action to limit pills. During last year's presidential election, he promised to leave abortion restrictions to individual states. After beating the White House, Trump said it was “impossible, very unlikely” to approve additional measures to limit access to abortion drugs. However, he refused to completely eliminate the idea, telling the interviewer that “people feel strongly in both ways.” He faces intense public and private pressure from his party's anti-abortion wing to criminalize the drug.
Sen. Josh Hawley, a Missouri Republican, said in a private conversation he asked Trump to have a particularly private conversation to revive rules requiring patients to pick up abortion pills directly. The move will severely reduce access to women in states with abortion bans.
“These requirements were never controversial until Joe Biden decided this was a good way to avoid Dobbs,” Hawley said in an interview last month. “Undoing face-to-face dispensing requirements is a simple call and I hope the administration does that.”
The legal battle over pills began just months after DOBBS's ruling. This comes when the coalition of anti-abortion rights groups and physicians asked Texas court to override PILL's FDA approval in 2000.
The Supreme Court ultimately refused their argument, saying that the group lacked legal status in the case as they were unable to provide evidence that they had been hurt by the tablets.
The latest case is a revised and expanded version of that case. It directly challenges Genbiopro's approval of generic mifepristone granted in 2019, aiming for broader rules aimed at expanding access to tablets.
The lawsuit bans drugs for people under the age of 18, revives in-person appointment requirements, requires only doctors to prescribe tablets, and limits the capabilities of resumes and retail pharmacies such as Walgreens, and asks them to distribute the medication.
The complaint also criticizes the Shield Act, passed in eight states. This protects doctors and other healthcare providers who prescribe and send abortion medication to patients in states with bans or restrictions. The lawsuits filed by conservatives in Louisiana and Texas challenge the protections provided by such laws.
Rather than filing the case in any of his hometown states, the state attorney general brought it before U.S. District Court J. Kakusmalik, Trump's appointee who heard the original case against access to abortion.
In April 2023, Judge Kacsmaryk issued a sweeping interim injunction that ruled in favour of anti-abortion groups and nullified the FDA's initial approval of Mifepristone. His decision was ultimately rejected by the Supreme Court.
