Access To Abortion Pill Mifepristone Could Be Threatened, Again

Forbes

2 days ago

In this photo illustration, packages of mifepristone tablets are displayed at a family planning ... More clinic. Mifepristone is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug misoprostol. (Photo illustration by)
The abortion pill mifepristone is in the crosshairs of politics again, as plaintiffs in several high-profile court cases together with Republican lawmakers push for restrictions. More importantly perhaps, the Food and Drug Administration is reviewing the regulation and labeling of mifepristone, a drug with a well-established safety and effectiveness record.
In an unusual move, Secretary of Health and Human Services, Robert F. Kennedy Jr., issued a statement last month to the Senate Health, Education, Labor and Pensions Committee directing the FDA to 'do a complete review' of its regulations on mifepristone, a medication used in conjunction with misoprostol in two-thirds of abortions in the United States– which has been used by more than eight million people since its approval more than two decades ago.
The FDA approved mifepristone in 2000 for medication abortion. Mifepristone is a drug that blocks progesterone, which is needed for a pregnancy to continue. When taken in conjunction with misoprostol, mifepristone ends early pregnancies (up to ten weeks following conception).
Mifepristone can be safely administered at home when prescribed by a provider, The FDA has allowed people to take the medication outside of a clinic setting since 2021. And that same year, the FDA further eased several conditions with respect to the prescribing and sale of mifepristone. Specifically, the regulatory authority allowed for prescriptions to be issued through telemedicine visits in addition to shipments of the product by mail, as MedPage Today reported.
It appears that rising numbers of abortions using prescription drugs in the past four years may be linked to the changes instituted by the FDA. In addition, the use of medication to end pregnancies could have also been triggered by the Supreme Court decision to overturn Roe v. Wade in 2022, as a Journal of the American Medical Association study describes.
But it appears that besides wanting to subject mifepristone to a new FDA review, Kennedy also wishes to reinstate the in-person dispensing requirement, which would mean women must go to a clinic to obtain mifepristone.
The Supreme Court preserved convenient access to mifepristone last year, throwing out a lawsuit that sought to reinstate the previous requirements. The justices' argument, however, largely hinged on questioning the physician plaintiffs' right to sue the FDA to restore conditions rather than the substance of the case.
But then, earlier this year, The Hill reported that a Texas federal judge, Matthew Kacsmaryk, is allowing three Republican-led states to move forward with a lawsuit to restrict access to mifepristone. It's noteworthy that in 2023, Kacsmaryk temporarily halted FDA's approval of mifepristone altogether.
In brief, it's unclear what will happen to access as cases move through the court system and findings from the review which Kennedy ordered are revealed.
Mifepristone has been in use in Europe for nearly three decades with a minimal number of reported adverse events. And the drug has had a similar safety record in the U.S since its approval in 2000. Between September 2000 and December 2018, only 24 of the more than 3.7 million women who had undergone medicated abortions have died, according to the FDA. Overall, the adverse events rate is less than 1% and the drug is considered safer than, say, over-the-counter non-steroidal anti-inflammatory drugs and anti-histamines.
At least 100 studies from around the world have examined the effectiveness and safety of mifepristone and misoprostol. All peer-reviewed studies concluded that the pills are a safe method for terminating a pregnancy. Yet there seems to be a non-peer-reviewed study that's at the center of a request for the FDA to assess mifepristone. It's from the conservative think tank, the Ethics and Public Policy Center. This particular study makes claims about what it views as a high rate of serious adverse events following medication abortions. Yet, the evidence from the U.S. and around the globe suggests a highly safe and effective medication.
The FDA's mandate is to review the safety and efficacy of drugs based on clinical evidence. As such, the FDA is the federal authority for all pharmaceuticals distributed throughout the U.S., including mifepristone and misoprostol. And so, a series of court cases and Secretary Kennedy's request for another look at mifepristone set a potentially unsettling precedent in which the FDA's regulatory authority from past decisions is undermined. And it's not just mifepristone that's currently under renewed scrutiny. Consider, for example, that HHS is revisiting debunked theories of links between the measles, mumps and rubella vaccine and autism. The department has also spearheaded changes in COVID-19 vaccine recommendations that are not necessarily evidence-based, and inconsistent with prior and even current guidance from the Centers for Disease Control and Prevention.