GenBioPro, the largest manufacturer of abortion pills in the U.S., has requested to join a lawsuit in Texas initiated by three Republican state attorneys general seeking to reverse FDA regulations that expanded access to the abortion pill mifepristone. The company aims to defend FDA approval amidst a political climate where the Trump administration may side with the plaintiffs to limit access. Abortion pills are critical, accounting for two-thirds of U.S. abortions, especially in states with strict bans. The lawsuit challenges multiple regulatory provisions, including telehealth prescriptions and pharmacy dispensing, escalating the fight over abortion access post-Dobbs ruling.
The nation’s top producer of abortion pills is getting involved in the first significant legal confrontation regarding abortion during President Trump’s second term.
GenBioPro, the company in question, has requested a Texas court to include it as a defendant in a lawsuit initiated last October by three Republican state attorneys general. This action is a notable offensive step in the ongoing struggle surrounding abortion access.
The lawsuit was submitted by the attorneys general from Missouri, Idaho, and Kansas, seeking to have a federal court overturn a series of Food and Drug Administration regulations that have significantly broadened access to the abortion pill mifepristone.
Under the Biden administration, the Justice Department defended the agency’s regulations and the F.D.A.’s approval of the drug, which occurred 25 years ago. However, many advocates for abortion rights believe that the Trump administration will refrain from defending the agency, effectively aligning with the state attorneys general and using this case to restrict access.
Should the judge approve GenBioPro’s request, the maneuver will enable the company to spearhead the defense of mifepristone. The company is being represented by Democracy Forward, a legal nonprofit that has initiated more than a dozen lawsuits and has successfully obtained multiple court orders against the Trump administration.
“The basis of these extreme politicians’ arguments is purely political, lacking scientific backing,” stated Skye Perryman, the president and chief executive of Democracy Forward. “The implications of this case for abortion access nationwide cannot be overstated.”
Abortion pills can be prescribed up to 12 weeks into a pregnancy and are utilized in nearly two-thirds of abortions in the United States. In regions where abortion is heavily restricted or outlawed, mail-order medication has become the predominant method to obtain the procedure.
Since the Supreme Court’s 2022 ruling in Dobbs v. Jackson Women’s Health Organization that annulled the constitutional right to abortion, healthcare providers in legal states report having sent over 10,000 abortion pills each month to patients within those jurisdictions.
Opponents of abortion have urged the administration to revoke regulations that permit prescriptions of the pills via telehealth appointments and their delivery by mail. They contend that in-person medical visits are essential for safeguarding patients. These efforts are part of a broader campaign to abolish all abortions. Research from more than 100 scientific studies conducted throughout the years has consistently shown that the pills are safe and infrequently result in serious complications.
GenBioPro, the sole manufacturer of abortion medication, holds approximately two-thirds of the market share for mifepristone. The other manufacturing entity, Danco Laboratories, is already listed as a defendant in this lawsuit.
“We are deeply concerned about extremist and special interest attempts to undermine the regulatory authority of the U.S. Food and Drug Administration,” remarked Evan Masingill, the chief executive of GenBioPro. “Every individual deserves access to safe, affordable, evidence-based healthcare, and GenBioPro remains dedicated to utilizing all legal and regulatory avenues to safeguard mifepristone for millions of patients and providers nationwide.”
It remains uncertain whether Mr. Trump will take measures to restrict the pills. During his campaign last year, he committed to leaving abortion regulation up to the states. After assuming the presidency, Mr. Trump stated that it was “unlikely, very unlikely” he would authorize further steps to limit access to the abortion pill. However, he did not completely dismiss the idea, suggesting that people “feel strongly both ways.” He faces significant public and private pressure from the anti-abortion faction of his party to criminalize the medication.
Senator Josh Hawley, a Republican from Missouri, claimed he specifically urged Mr. Trump in a private discussion to reestablish rules requiring patients to obtain abortion medication in person. Such a move would drastically reduce access for women in states with abortion bans.
“These requirements were never a point of contention until Joe Biden decided it was a strategic way to bypass Dobbs,” Mr. Hawley commented in a recent interview. “Reinstating the in-person dispensing requirement is a straightforward decision, and I hope the administration will pursue that.”
The legal battle over the pill commenced merely months after the Dobbs ruling when a coalition of anti-abortion rights groups and physicians petitioned a Texas court to overturn the F.D.A.’s approval of the pill from 2000.
The Supreme Court ultimately dismissed their claim, arguing that the groups lacked the legal standing to sue as they could not demonstrate any harm caused by the pills.
The latest lawsuit represents an updated and more extensive version of that case. It directly contests GenBioPro’s approval for generic mifepristone, which was granted in 2019, and targets a broader array of regulations designed to enhance access to the pills.
The lawsuit requests the court to prohibit the medication for anyone under 18, reinstate the in-person appointment requirement, mandate that only licensed doctors can prescribe the pills, and restrict retail pharmacies like CVS and Walgreens from dispensing the medication.
Additionally, the complaint targets shield laws, established in eight states, that protect healthcare providers who prescribe and send abortion pills to patients in areas with bans or restrictions. Conservative lawsuits in Louisiana and Texas are challenging the protections these laws provide.
Instead of filing the case in their home states, the state attorneys general chose to bring it before Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, a Trump appointee who possesses a history of opposing abortion access and heard the original lawsuit.
In April 2023, Judge Kacsmaryk ruled in favor of the anti-abortion groups, issuing a broad preliminary injunction that invalidated the F.D.A.’s initial approval of mifepristone, a ruling that was later overturned by the Supreme Court.