4 days ago
Massachusetts joins three other Democrat-led states asking FDA to remove abortion pill restrictions
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Abortion pills — particularly mifepristone — have become the focus of legal battles and new legislation seeking to expand or further curtail access to the procedure since the Supreme Court overturned Roe v. Wade in 2022, and with it, the national right to abortion. Thursday's petition comes days after FDA Commissioner Marty Makary said he would conduct a review of the drug, alarming reproductive health advocates who worry the agency is gearing up to further limit access.
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A spokesperson for the Department of Health and Human Services, which includes the FDA, said HHS Secretary Robert F. Kennedy Jr. had asked Makary to review mifepristone data. The spokesperson added that Makary 'will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes.'
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A large body of research shows mifepristone, first approved more than two decades ago, is safe and effective. It is used in the majority of abortions in the United States.
The Democratic attorneys general asked the FDA to review the restrictions on mifepristone Thursday through a citizen petition submitted to HHS and the FDA. By law, the FDA is required to respond within 180 days of receiving the petition — granting, denying or dismissing it, or justifying why it has not reached a decision on the matter. In the month after a decision, petitioners can ask the FDA to reconsider. After that, they have the option to take the issue to court.
The four attorneys general are asking the FDA to remove requirements under its Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program that mandate pharmacy certification, which involves using shippers that provide tracking and patient agreement forms for receiving the drug. They are also asking the FDA to remove prescriber certification requirements, saying the restrictions 'can discourage clinicians from offering it,' according to the petition.
To prescribe mifepristone, clinicians have to send a certification form to the pharmacies their patients will visit to receive the drug. That process poses safety risks 'should such lists be leaked or compromised,' the petition says.
Those risks for abortion providers are 'all the more prevalent now given the number of states that have criminalized abortion and are seeking to punish providers who have facilitated medication abortions for patients who reside in other states,' the petition says. It alludes to the first-of-its-kind prosecution this year of a New York doctor who allegedly prescribed abortion pills to a patient in Louisiana.
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In a statement Thursday, James said these restrictions discourage many family medicine practices and primary care clinics from stocking or prescribing mifepristone, which particularly impacts 'rural and underserved communities' that have no alternative health-care options.
According to the FDA, the Mifespristone REMS program is intended to 'mitigate the risk of serious complications' associated with the drug 'by, among other things, requiring that prescribers have the necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.'
Some Republicans have been pushing the FDA to reassess the safety of mifepristone, based on a study conducted by a conservative think tank that said it found the risk of serious adverse events from taking the drug is much higher than advertised. The study is not peer-reviewed and does not reveal the database used for it.
The Washington Post Fact Checker analyzed the study, which was conducted by the Ethics and Public Policy Center, and noted that it found similar rates for the most serious problems associated with abortion, such as sepsis, infection, and emergency-room visits, as are listed on the FDA-approved label of Mifeprex, the brand name for the abortion pill.
According to the FDA's prescribing information on mifepristone, fewer than 0.5 percent of people taking the drug with misoprostol to end pregnancy experienced serious adverse reactions.
On Thursday, the attorneys general rebuked 'recent attempts to challenge mifepristone's safety using methodologically flawed scientific research papers, noting that several of these papers have been retracted by medical journals.'
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'The coalition are urging the FDA to use this full review of mifepristone to lift unjustified restrictions and maximize access to this essential medication,' James's statement said.
