Editor’s note: Anti-abortion advocates are trying to revoke FDA drug approval. This is scary
In the post-Roe world, one of the main targets of anti-abortion activists is medical abortion, a two-component regimen in which a pregnant woman takes mifepristone and then misoprostol.
A lawsuit filed late last year by anti-abortion federal district court in Amarillo, Texas, asks Judge Matthew Kachsmarik, a conservative known for his his anti-abortion views, withdraw US Food and Drug Administration approval for mifepristone. They argue that the agency did not properly examine the drug and removed “even the most basic precautions” associated with its use. Kachmarik is expected to make a decision any day now.
The claim is weak given that medical abortion has been available in the US since 2000, currently used in more than half of abortions in that country and in exceptional cases efficient and safe (with serious side effects in less than a third of 1% of abortions). If anything, healthcare providers and researchers feel it’s over-regulated. For years, getting a prescription for abortion medication required at least one in-person visit, and it was only available at certain medical facilities and under certain conditions. Recently, the Food and Drug Administration expanded the rules allow telemedicine visits to obtain a prescription and allow dispensing of medicines through pharmacies that meet certain requirements. (However, on Friday, Walgreens, one of the nation’s largest retail pharmacies, succumbed to pressure and announced it will stop providing mifepristone in 20 states where attorneys general are challenging the legality of its use.
Lawyers for the Department of Justice and the FDA say the department comprehensively evaluated mifepristone before approving it for medical abortion. IN court documents, they say the agency “analyzed three separate clinical trials involving more than 2,500 pregnant patients, and these trials provided substantial evidence of efficacy and showed a low rate of serious side effects.” The Food and Drug Administration (FDA) also defended the drug as offering “significant therapeutic benefit in some patients compared to surgical abortion” because it avoids the invasive (albeit very safe) surgical abortion procedure.
Lawyers believe that if the judge revokes the FDA’s approval for the use of mifepristone, this would be an unprecedented case. “We are not aware of any case where a court has removed a drug from the market over the objections of the FDA,” a group of food and drug law scholars wrote in the journal. summary for FDA.
It would also be another medically unsound attempt by anti-abortion advocates to deprive pregnant women of access to health care. Nearly half of the country’s states have abortion bans or restrictions so severe that they severely restrict access. Now, anti-abortion activists are trying to impose restrictions on access to abortion in states where it is legal and protected.
Fortunately, removing mifepristone, which is used primarily for abortion and miscarriage treatment, from the market will not stop medical abortions, although it could sow confusion and upheaval throughout the country. A second drug, misoprostol, can be used alone to terminate a pregnancy, although it is somewhat less effective. It is not subject to the same restrictions because it has a different clinical use, such as treating stomach ulcers.
According to Lauren Kokum, Director of Partner Relations for the Planned Parenthood Federation of America, a two-drug regimen works 99% of the time, while a misoprostol-only regimen works 97% of the time. The organization authorizes its 49 affiliates, which operate 600 US medical centers, to use only misoprostol.
Meanwhile, state legislatures continue to impose new restrictions on abortion. Iowa lawmakers recently introduced a bill that not only bans abortion, but adds the ridiculous requirement that ISPs block people from accessing abortion-related websites while they are in the state.
The extremes that anti-abortion activists will go to should worry everyone who cares about exercising civil rights, especially the right to control one’s own body. These attacks on access to abortion will continue either until each state passes a constitutional amendment guaranteeing the right to abortion, or until Congress passes a national law. law legal abortion in every state. Think about it the next time you vote for a member of Congress.