Court Deals Blow to Lawsuit from Abortion Drug Manufacturer

All women and girls deserve protection, and the U.S. Supreme Court’s decision overturning Roe v. Wade ensured that states can provide this protection by enacting laws that safeguard women and girls from high-risk abortion drugs.

But in West Virginia, a major pharmaceutical company is prioritizing profit over safety and challenging a law that enacts commonsense safeguards around these high-risk drugs. West Virginia’s law protecting women and girls is both constitutional and necessary, so Alliance Defending Freedom is helping defend the law in court.

What is GenBioPro?

GenBioPro is a highly profitable company that manufactures only one drug: the abortion drug mifepristone. Its business model relies on selling as many abortion drugs as possible, which is why the company is fighting a West Virginia law protecting women from these high-risk drugs.

According to GenBioPro’s own website, it exists to provide abortion drugs to “all people – regardless of income, gender, race, or geography.” The company has prioritized profits and ignored safety risks by continually pushing these drugs to anyone who will buy them.

GenBioPro v. Raynes

The U.S. Food and Drug Administration (FDA) approved abortion drugs for use in America with minimal restrictions in 2000. Since 2016, the agency has been eroding the safety standards it had originally deemed necessary.

In 2016, the FDA extended the permissible use of abortion drugs from seven weeks’ gestation up to 10 weeks’ gestation, changed the drugs’ dosage and route of administration, reduced the number of required in-person office visits for women seeking the drugs from three to one, allowed people who are not medical doctors to prescribe the drugs, and eliminated the requirement for prescribers to report complications from the drugs unless the mother actually dies.

In 2021, the FDA announced what it claimed was a temporary change suspending the requirement for women to have in-person office visits before being prescribed abortion drugs. Later that year, it made the change permanent, meaning women can now be prescribed these drugs via telehealth and receive them in the mail. (ADF has challenged the FDA’s erosion of safety standards in court, and the Supreme Court has agreed to hear the case. Read more about that lawsuit here.)

In Dobbs v. Jackson Women's Health Organization, the Supreme Court empowered all 50 states to protect life. As a result, West Virginia passed a new law called the Unborn Child Protection Act. The law protects unborn babies at all stages of development.

In the same bill, West Virginia amended previous law to clarify that non-licensed medical professionals cannot perform abortions under any circumstances, nor can they prescribe abortion drugs. The new law also required that doctors dispense abortion drugs in person rather than through the mail, just as the FDA required prior to 2021.

West Virginia has every right to determine its own abortion laws thanks to the Court’s decision in Dobbs. But because this law threatened GenBioPro’s profits, the drug manufacturer sued the state without any legal basis.

GenBioPro’s lawsuit falsely claims that the FDA’s approval of abortion drugs supersedes West Virginia’s right to make its own abortion laws that protect women, girls, and unborn children. Since this claim runs directly counter to the law, ADF is asking a federal district court to dismiss the baseless lawsuit.

What’s at stake?

States have the right to pass laws that promote the welfare of their citizens. West Virginia’s law does just that, protecting women, girls, and unborn children from high-risk abortion drugs. Many other states have similar laws.

But if GenBioPro has its way, states will no longer be able to implement necessary safety protocols to protect their citizens from these drugs. The district court should follow the Supreme Court’s lead in Dobbs and affirm that West Virginia’s law should be enforced.

Case timeline

• January 2023: GenBioPro filed a lawsuit falsely claiming that the FDA’s approval of abortion drugs supersedes West Virginia’s right to pass its own abortion laws.
• February 2023: ADF asked a federal district court to dismiss the unfounded lawsuit.
• August 2023: The district court partially dismissed GenBioPro’s challenge to the laws in West Virginia. The court said the only pro-life protection that GenBioPro can challenge is the law requiring women to see a physician in person before obtaining abortion drugs.

The bottom line

West Virginia’s laws protect the health, safety, and welfare of women and girls from high-risk abortion drugs. Major abortion drug manufacturers can’t ignore state laws protecting women and girls just to bolster their business.