California Attorney General Rob Bonta
California’s attorney general has joined with his counterparts in Massachusetts, New York and New Jersey to petition the federal Food and Drug Administration to lift the remaining restrictions on the use of the abortion drug mifepristone.
Attorney General Rob Bonta joined with the other states on June 5 in a call to end restrictions on the medication that have been imposed through the FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program. The move appears to be the latest chapter in the debate over the safety of mifepristone and how patients can access the drug. The science governing the drug’s use has also been at the center of civil litigation by abortion opponents challenging FDA approval of the drug.
The petition filed by the four states seeks an end to what the states see as burdensome and unnecessary REMS requirements involving prescriber certification, the use of patient agreement forms and pharmacy certification, which puts in place detailed tracking, shipping and reporting rules.
That action by the attorneys general comes in the wake of the secretary of Health and Human Services, Robert F. Kennedy Jr., last month testifying that he had ordered an FDA review of mifepristone safety and labeling requirements.
Kennedy’s announcement comes amid claims that mifepristone is not as safe as the FDA has affirmed during its decades-long review. The advocacy group Ethics and Public Policy Center (EPPC) released a study in May that found the abortion drug has a real-world failure rate of 5.26%, meaning that one in 19 cases do not produce the intended results. The reported failure rate is twice the level previously reported in U.S. clinical trials, the EPPC reported.
“This real-world data reveals the disturbing truth about the abortion pill to the public for the first time.,” EPPC President Ryan Anderson said in a statement in May. “Last week we showed that the pill is far less safe than the FDA has said. Now, we show that the pill is far less effective than the FDA has said. The public deserves a clear and honest evaluation of this drug.”
The authors of the study urged the FDA to immediately put back in place stronger safety protocols on mifepristone, including the reporting of side effects.
But Stella Dantas, a physician and past president of the American College of Obstetricians and Gynecologists, told the Southern California Record that the study contained serious flaws.
“This report is ideologically biased and manipulates data to drive a myth that medication abortion isn't safe,” Dantas said. She added that the study appears at odds with evidence-based research because it lacks a process involving an institutional review board and peer review, as well as the failure to publish specific diagnosis codes.
The diagnosis codes could include patients who entered an emergency room for an unrelated problem, such as a car accident, but may have recently had a medication abortion, she said.
“Additionally, this report's methodology does not ensure that complications associated with spontaneous abortions, or miscarriages for which mifepristone is routinely prescribed, were not included,” Dantas said.
Decades of peer-reviewed research show the medication is safe, with adverse events occurring in fewer than 0.3% of patients, she said. In addition, mifepristone patients who seek follow-up care in emergency rooms – and may be subject to reporting – may not actually need additional medical treatment, only an assurance that “their experiences are normal,” according to Dantas.
Under the FDA’s REMS program, pharmacists or other medical professions who fail to comply with the program’s requirements can be subject to civil measures if issues found during FDA inspections are not quickly remedied. A failure to comply with REMS requirements can result in an injunction, warning letters, civil monetary penalties or product seizures, according to the FDA.
