A dozen states sue the FDA in hopes of easing abortion pill restrictions

In the latest flare up over access to the abortion pill, a dozen states filed a lawsuit to force the U.S. Food and Drug Administration to ease restrictions on how mifepristone is prescribed and made available to patients.

At issue is a risk mitigation program, which is used to ensure certain prescription medicines considered to carry significant risks are prescribed and taken safely. The FDA has required such a program for only a few dozen drugs, including the abortion pill. But the attorneys general say the program is needless for mifepristone, and argue its requirements can frighten patients and prescribers who are concerned about privacy and safety.

Under the program, prescribers must be certified by the company supplying the pill. Both patients and providers must sign an agreement affirming that the patient is taking the pill and a second drug, misoprostol, in order to end their pregnancy. The pill can be used for abortion or to treat a miscarriage. And pharmacies must also obtain special certification before they can fill a prescription.


The attorneys general contend, however, that FDA requirements that certifications and patient agreements must be disclosed “could expose them to violence, harassment or abuse.” They also maintained that the information could be used to threaten health care providers or patients with legal liability in states, depending upon anti-abortion laws.

In their lawsuit, the attorneys general noted mifepristone is associated with fewer serious side effects and deaths than common drugs such as Viagra, which does not have a risk mitigation program. They also cited FDA data showing no deaths attributed to mifepristone. Despite that, the attorneys general noted, the agency has repeatedly declined to remove the restrictions.


“Mifepristone is safer than Tylenol. Despite that, the FDA imposes needless restrictions reserved for some of the highest risk drugs, including fentanyl,” Connecticut Attorney General William Tong said in a statement. “Our suit seeks to block these unnecessary and unlawful restrictions and to ensure that regulation of medication abortion is based strictly on science and safety.”

Separately, they filed a preliminary injunction seeking to halt FDA enforcement of the restrictions on mifepristone while the case continues.

The latest lawsuit was praised by reproductive rights advocates.

“For over 20 years, mifepristone has helped expand access to abortion care, allowing patients to make their own private medical decisions,” said Rebecca Gibron, who heads Planned Parenthood in the Pacific Northwest and other states. “There is overwhelming evidence that medication abortion is safe and effective for virtually anyone who wants to end an early pregnancy.”

The case comes amid nationwide debate over access to abortion, and in particular, abortion pills. After the U.S. Supreme Court struck down Roe v. Wade last year, ruling that abortion is not a fundamental right, numerous states to passed or pursued laws to restrict abortions. The legislative battles have left health care providers uncertain of how to grapple with new laws and restrictions, including bans on abortion pills that have been long approved by the FDA.

Last month, abortion rights supporters filed lawsuits challenging restrictive laws in two states, North Carolina and West Virginia. The lawsuits claim the laws are unconstitutional, because they restrict access to the pill beyond what was designated by the FDA. The argument raises a notion called preemption, which refers to the premise that federal law trumps a state law.

Meanwhile, an advocacy group, the Alliance for Hippocratic Medicine, last November filed a lawsuit challenging the right of the FDA to have approved mifepristone in the first place. The case, which is being heard by a conservative federal court judge in Texas appointed by former President Trump, is being closely watched because some fear it has the potential to undermine FDA authority.

Although the anti-abortion group and its supporters believe the FDA wrongfully approved mifepristone, many legal and regulatory experts say the notion is misguided. Nonetheless, the lawsuit is sparking concern that, if the anti-abortion group wins its case, others that object to a medicine or vaccine will similarly challenge FDA authority.

Source: STAT