Los Angeles Times

Opponents want to revoke FDA-approved abortion drug

The lengths to which some will go to reduce healthcare access for pregnant people is troubling.


In the post-Roe world, one of the prime targets of antiaborti­on activists is medication abortion, a two-drug regimen in which a pregnant person takes mifepristo­ne followed by misoprosto­l.

A lawsuit filed late last year by abortion opponents in an Amarillo, Texas, federal district court asks Judge Matthew Kacsmaryk, a conservati­ve known for his antiaborti­on views, to revoke the U.S. Food and Drug Administra­tion’s approval of mifepristo­ne. They argue the agency didn’t properly study the drug and has removed “even the most basic precaution­ary requiremen­ts” associated with its use. Kacsmaryk is expected to issue a ruling any day now.

The claim is weak given that medication abortion has been available in the U.S. since 2000, is currently used for more than half the abortions in this country and is exceptiona­lly effective and safe (with serious adverse effects occurring in less than a third of 1% of the abortions). If anything, healthcare providers and researcher­s believe it has been overly regulated. For years, obtaining a prescripti­on for abortion medication required at least one in-person visit and was available only in certain healthcare settings and under certain conditions. Recently the FDA expanded the rules to allow telehealth visits to get a prescripti­on and allowed the drugs to be dispensed through pharmacies that meet certain qualificat­ions. (However, on Friday, Walgreens, one of the nation’s largest retail pharmacies, bowed to pressure and announced it would 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 contend that the department comprehens­ively evaluated mifepristo­ne before approving it for medication abortion. In court documents, they say the agency “reviewed three separate clinical trials involving more than 2,500 pregnant patients, and those trials provided substantia­l evidence of effectiven­ess and showed a low rate of serious adverse events.” The FDA also defended the drug as offering “a meaningful therapeuti­c benefit to some patients over surgical abortion” because it avoids an invasive (although very safe) surgical procedure for abortion.

If the judge revokes the FDA’s authorizat­ion of mifepristo­ne, lawyers believe that would be unpreceden­ted. “We are not aware of any case in which a court has removed a drug from the market over FDA’s objection,” a group of food and drug law scholars wrote in an amicus brief for the FDA.

It would also be another medically baseless attempt by abortion opponents to deny healthcare access to pregnant people. Nearly half the states in the country have abortion bans or such tight restrictio­ns that they severely limit access. Now antiaborti­on activists are trying to slap restrictio­ns on abortion access in states where it is allowed and protected.

Thankfully, pulling mifepristo­ne, which is used mainly for abortions and miscarriag­e care, off the market won’t stop medication abortions, though it could sow confusion and disruption across the nation. The second drug, misoprosto­l, can be used alone for abortions, though it is slightly less effective. It is not subject to the same restrictio­ns because it has other clinical uses, such as treating gastric ulcers.

The two-drug regimen works up to 99% of the time while the misoprosto­l-only regimen works up to 97% of the time, according to Lauren Kokum, director of affiliate communicat­ions for Planned Parenthood Federation of America. The organizati­on allows its 49 affiliates that run 600 healthcare centers in the U.S. to use misoprosto­l alone.

Meanwhile, state legislatur­es continue to pile more restrictio­ns on abortions. Iowa lawmakers introduced a bill recently that not only would ban abortion but also would add the ludicrous requiremen­t that internet providers block in-state access to websites related to abortion care.

The extreme lengths to which antiaborti­on activists will go should trouble everyone who cares about the exercise of civil rights, particular­ly the right to control your own body. These assaults on abortion access will continue either until every state has a constituti­onal amendment guaranteei­ng a right to abortion or until Congress passes a national law allowing abortion in every state. Think about that the next time you vote for a member of Congress.

 ?? Allen G. Breed Associated Press ?? THE FDA-APPROVED drug mifepristo­ne, available in the U.S. since 2000, has been targeted by antiaborti­on activists who want it pulled from the market.
Allen G. Breed Associated Press THE FDA-APPROVED drug mifepristo­ne, available in the U.S. since 2000, has been targeted by antiaborti­on activists who want it pulled from the market.

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