Washington's Strategy to Preserve Mifepristone Access

Since Roe v. Wade was overturned last summer, abortion medication has been under fire as the abortion drug mifepristone is the subject of a federal lawsuit and some states are attempting to restrict access by threatening legal action against retail pharmacies and suppliers of the drug.

As the nation grapples with continuing changes in court rulings affecting the U.S. Food and Drug Administration’s approval of a drug used in abortion care, Washington state’s competing lawsuit and other offensive and defensive moves related to abortion are working exactly as officials and advocates say they intended.

The Legal Challenge Against FDA Restrictions

Washington Attorney General Bob Ferguson’s office filed a lawsuit against the FDA in late February, about a month after the federal agency announced it would keep mifepristone under restrictions associated with its Risk Evaluation and Mitigation Strategies program — also known as REMS. In the complaint, Ferguson’s office argued the FDA’s restrictions on mifepristone are unreasonable given its safety and effectiveness record over the past 23 years, and that the restrictions create undue administrative and financial burdens on providers and make it more difficult for patients to access the medication via telehealth.

While U.S. District Judge Thomas Rice has not yet ruled whether those restrictions should be lifted, he did issue an injunction preserving the FDA’s requirements as they are in the 17 states and Washington, D.C., until the case is resolved.

The Nature of Mifepristone and REMS Requirements

Mifepristone blocks production of a hormone called progesterone, which is vital to the continuation of a pregnancy. It is a drug used in tandem with another to end a pregnancy of up to 10 weeks’ gestation. The FDA requires health care providers who prescribe mifepristone to be certified in its REMS program and mandates the drug be dispensed by or under the supervision of certified prescribers or pharmacies. Providers must also inform patients about “the risk of serious complications associated with mifepristone.”

As part of the announcement earlier this year, the FDA also said it would loosen its dispensing requirements, allowing pharmacies to prescribe it directly. The FDA has said its certification process for physicians ensures the provider has the ability to accurately date a pregnancy, diagnose ectopic pregnancies and provide or arrange for surgical intervention if necessary.

Safety Data and Drug Comparisons

Regarding safety, as of April 2023, REMS requirements are in place for 63 of the more than 20,000 drugs approved by the FDA for marketing in the U.S. The REMS are assigned to certain drugs to ensure that the benefits of the drug or biological product outweigh the risks, according to the FDA. Some of the 63 drugs are highly potent medications used to treat various forms of cancer or severe psychiatric disorders, and some are opioids with high risks of addiction and dependence.

To summarize the safety profile of mifepristone based on the provided data:

• Mifepristone Safety Record: The FDA has recorded 28 deaths following the use of the drug out of 5.6 million uses and has stated mifepristone cannot be identified as a cause of those deaths.
• Comparative Mortality: Advocates often point out that mifepristone is safer than Tylenol and Viagra, the latter of which was associated with 522 deaths after its first 13 months on the market in 1998, according to FDA data.
• Causes of Recorded Deaths: Nine of the deaths were caused by septic infections, and a majority of the remaining deaths involved homicide, drug overdoses, ruptured ectopic pregnancies and suicide.

Expert Perspectives on the Strategy

Molly Meegan, chief legal officer and general counsel for the American College of Obstetricians and Gynecologists, said REMS are generally used when there is a danger to the patient or when the administration of a drug needs to be controlled. She noted that time has proven that there really is no danger, that it’s very safe and very effective. Meegan concluded that the Washington case was a very interesting use of the federal courts to try to make sure that a safe, effective drug was available in the states that wanted it to be.