The National Catholic Bioethics Center

View Original

The FDA and Mifepristone Abortions

To view a PDF of this document, click here.

Direct abortion is never ethically acceptable from a Catholic perspective. The grave intrinsic evil can be made even worse, however, under some circumstances. The US Food and Drug Administration (FDA) has found ways to do so with its approval of and subsequent loosening of restrictions on mifepristone or so-called medication abortions. The National Catholic Bioethics Center (NCBC) recently joined an amicus curiae or “friend of the court” brief in support of a reversal of the FDA’s approval of mifepristone as a drug for causing abortions.

The lawsuit in the federal court for the Northern District of Texas points out some shocking facts concerning the fast-track FDA drug approval of mifepristone for abortions in 2000. “The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments.” Only the most hardened of radical feminists use the ridiculous “pregnancy is a sexually transmitted disease” claim. The FDA, however, went further by considering pregnancy a serious or life-threatening illness in need of “treatment” by abortion.

The FDA should be protecting the health, safety, and welfare of all Americans and rejecting or limiting the use of dangerous drugs. The lawsuit points out how, since 2000, the FDA has failed to carry out this mandate with regard to the use of mifepristone. In fact, since the original approval, the FDA has repeatedly made it easier to access chemical abortions. Making drug-induced abortions easy to obtain has had huge effects. We have now reached the point where most US abortions are done using mifepristone and not surgical techniques.

In 2016, the FDA extended the time limit for abortion using mifepristone from seven weeks of pregnancy to ten weeks. Then in 2021, they allowed abortion practitioners to send mifepristone through the mail. Most recently, in 2023, the FDA allows women and girls to receive a prescription for mifepristone via telemedicine from pharmacies. CVS and Walgreens announced publicly that they plan to provide mifepristone directly to the public with a prescription under the new rules, or mail them, although they are not allowed to send the drugs across state lines.

This legal challenge is a tremendous opportunity to undo the damage done by the FDA and has drawn support from 23 states and many others to ask the judge to issue an injunction against the approved use of mifepristone for abortion. The article linked above gives a good summary of the claims by the Alliance for Hippocratic Medicine and other plaintiffs. “The lawsuit alleges that the FDA never studied the safety of mifepristone under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded evidence that chemical abortion drugs cause more complications than surgical abortion, and eliminated necessary safeguards for pregnant girls and women who take the regimen.” (The Alliance for Hippocratic Medicine is the secular counterpart to the Catholic Health Care Leadership Alliance, which the NCBC helped to found.)

The amicus brief we signed points to the fact that these telemedicine abortions, where the mother is never examined by a doctor, are about blatantly increasing the ease of accessing abortions rather than any medical or ethical consideration. Potentially life-threatening ectopic pregnancies will not be detected or treated without the safety precaution of medical examinations. Being sure of the gestational age of the preborn child is most safely done when determined by professionals.

More from the brief:  

In order to obtain genuine informed consent, a healthcare provider must inform the patient of the medical condition necessitating the proposed treatment or procedure and must also explain any risks, such as those related to contraindications or conditions that increase the likelihood of the patient’s risk. However, FDA does not require certified prescribers of mifepristone to adequately screen their patients for potential risks, which means that they cannot satisfy this requirement. A certified prescriber who merely consults with a patient though video, phone, or email, which is now explicitly permitted by FDA, cannot accurately assess the duration of a patient’s pregnancy, diagnose ectopic pregnancy, or even establish a provider-patient relationship that empowers patients to trust the prescriber or the prescriber’s designee for care in an emergency.

Please pray that the judge will rule, not only that abortion is barbaric, but the FDA violated its own mandate to help keep people safe by rushed approval of mifepristone and by loosening the restrictions on its use. A court injunction could stop mifepristone “medication abortions” in all 50 states. The Biden administration is certain to appeal, but the ethics and health and safety arguments are strongly against allowing mifepristone to do its deadly action. A strong reaction is also warranted against Walgreens and CVS for being so eager to provide abortion pills. Those who are pro-life should let them know of their disapproval and intention not to use their stores or products.

 


See this gallery in the original post