West News Wire: Twelve states have sued the federal government of the United States over the availability of the abortion drug mifepristone, with Washington and Oregon in the lead.
They said that “especially severe” limits put on the drug by the US Food and Drug Administration (FDA) make it more difficult for patients to get the prescription when they need it.
The FDA “has continued to obstruct access by singling out mifepristone and the persons in the Plaintiff States who rely on it for their reproductive health care” for a special set of restrictions, according to the lawsuit,”
After the Supreme Court’s decision to overrule Roe v. Wade in June, which had previously upheld reproductive rights, the availability of tablets to abort early pregnancy has become a crucial flashpoint for reproductive rights in the US.
The states involved in the lawsuit, filed Thursday, included Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont. All 12 are Democrat-led.
“The availability of medication abortion has never been more important,” the states wrote. “As states across the country have moved to criminalise and civilly penalise abortion, the Plaintiff States have preserved the right to access abortion care and have welcomed people from other states.”
Developed in 1980, mifepristone has been approved by the FDA since 2000 as the first part of a two-drug regimen to end pregnancies under 10 weeks. It is taken in combination with misoprostol, another pill.
According to the Guttmacher Institute, a reproductive health nonprofit, an estimated 54 percent of abortions in the US employ abortion pills, with that number expected to rise as telehealth increases the frequency of remote medical consultations.
But the FDA has categorised mifepristone under its Risk Evaluation and Mitigation Strategies (REMS) programme, a drug safety framework for “certain medications with serious safety concerns”.
The 12 states are pushing for the US District Court in the Eastern District of Washington to remove mifepristone from the programme.
They argue that mifepristone has been used more than five million times “with very low rates of complications” and that the REMS designation puts the pill in a “very limited class of dangerous drugs”.
The federal government “has imposed REMS for only 60 of the more than 20,000 FDA-approved prescription drug products marketed in the US”, the lawsuit alleges.
“These cover dangerous drugs such as fentanyl and other opioids, certain risky cancer drugs and high-dose sedatives used for patients with psychosis.”
After a review, the FDA agreed to modify mifepristone’s REMS programme, effective on January 3, “to reduce burden on the health care delivery system”.