Dem State Attorneys General Push FDA to Drop Limits on Abortion Pill During Pandemic

By Randall K. O’Bannon, Ph.D. NRL Director of Education & Research

Demonstrating that even a world health crisis is not enough to sway them from their fixation on abortion, several Democrat state attorneys general have sent a letter to the commissioner of the U.S. Food and Drug Administration (FDA) asking that regulatory restrictions on the distribution and prescription of mifepristone, the abortion pill, be lifted.

This is an outcome abortion pill advocates have sought for years, hoping to make the two-drug chemical abortion technique more broadly available in America. 

The FDA has already loosened restrictions on RU-486 (mifepristone) in a number of ways since it was first given approval in September of 2000. It altered recommended dosages, extended the latest point in pregnancy it could be used, reduced the timeline and the qualifications for prescribers. However, advocates have been vocally unhappy that the FDA continued to require abortionists to certify their understanding of the chemical abortion process and risks and to buy their pills directly from the distributor.

Advocates, by contrast, want, at a minimum, to be able to screen potential patients online and either ship them these pills through the mail or have them pick them up from their local pharmacy.

They have used this latest viral crisis with COVID-19 to argue that prescribing these pills online and having them delivered for home use offers women a safer way to abort and would minimize the use of already stretched medical personnel and resources.  

Risks posed by the abortion pill to women going through an otherwise natural, healthy pregnancy are rarely seriously considered, and the life of the unborn child is not considered at all.

Written in Blood?

In what was obviously a coordinated effort, the joint letter signed by 21 Democrat Attorneys General [FN The list of signatories includes: Xavier Becerra (California), Phil Weiser (Colorado), William Tong (Connecticut), Kathleen Jennings (Delaware), Karl A. Racine (Washington, D.C.), Clare E. Connors (Hawai’i), Kwame Raoul (Illinois), Tom Miller (Iowa), Aaron M. Frey (Maine), Brian E. Frosh (Maryland), Maura Healey (Massachusetts), Keith Ellison (Minnesota), Aaron D. Ford (Nevada), Hector Balderas (New Mexico), Letitia James (New York), Joshua H. Stein (North Carolina), Ellen F. Rosenblum (Oregon), Josh Shapiro (Pennsylvania), Peter F Neronha (Rhode Island), Thomas J. Donovan, Jr. (Vermont), Mark R. Herring (Virginia)] asked the FDA Commissioner Stephen Hahn and the U.S. Secretary of Health and Human Services Alex M. Azar II to “increase access to reproductive healthcare, including safe and legal abortion, during this pandemic.”  

They specifically urge the FDA to waive its “Risk Evaluation and Mitigation Strategy” (REMS) restrictions or to use its enforcement discretion to “allow certified prescribers to use telehealth for Mifepristone.”

They insist that those REMS restrictions that require registration and certification of the prescriber and allow them to be ordered only directly from the distributor create “unnecessary barriers between women and abortion care, not only making it harder to find—for example, by prohibiting sale by retail or mail-order pharmacies—but also making it unappealing to prescribe.” 

Further, the attorneys general complain, the REMS requirement that the patient be handed the mifepristone at the clinic, medical office, or hospital under the supervision of a health care provide amounts to “barring the use of telehealth,” thereby forcing women to go out for their abortions precisely when governments are urging folks to stay home.

Like many abortion pill advocates who have been trying to make their case in the medical establishment, the Democrat state AGs claim that the drug’s safety and efficacy has been proven in two decades of use. They say that even the FDA grants that “serious complications have proven rare.”

While this is true, the FDA has also recorded nearly two dozen deaths and thousands of complications associated with use of these dangerous pills. Those “adverse events” include serious infections, severe hemorrhage, and the rupture of previously undiscovered ectopic pregnancies. This documented record justifies the FDA keeping the REMS regulations in place.  

While there is, as of yet, no official record of a response to the AGs’ letter by the FDA, an FDA spokesperson responded to a similar recent request from abortion advocates (coincidence?). The spokesperson restated the policy that such regulations were put in place “in order to assure that the benefits of the drug outweigh the risks” (“Abortion Pill Restrictions Won’t Be Lifted During Pandemic, FDA Says,” vice.com, 3/19/20).

In summary, the AGs argue that “In light of the unprecedented COVID-19 crisis, we request you remove the FDA’s restrictive REMS designation for Mifepristone thereby removing these unnecessary, undue burdens in accessing safe and time-sensitive, essential medical care.” 

Say, that looks familiar

It is hardly coincidental that this letter appears on the heels of and echoes the language of, a joint statement by the American College of Obstetricians and Gynecologists and other reliable abortion friendly medical societies. The statement demanded that abortion be recognized as essential and “time-sensitive” healthcare in a time when government is urging that people postpone non-essential medical services. 

Because of the FDA’s REMS requirements, “women seeking to obtain healthcare” (that is, abortion) and follow state directives to “shelter-in-place,” “cannot abide by such requirements,” the joint statement reads.  “These women” they say, are “putting themselves and their families at risk when they seek out the healthcare that they need.”

Thus, ACOG et al. demand that “the federal government must act to ensure that no matter where they live, they can continue to receive necessary, safe, and legal abortion care.”

The AGs assert, but do not explain how these abortions are supposed to be “necessary” or “essential” services, particularly at a time when medical care and personnel are desperately needed to fight the Corona virus.

There is no evidence, no claim that they are speaking on behalf of women with medical conditions whose lives be threatened by the continuation of their pregnancies.  What they do offer is simply that there are women who want abortions; that there are people who want to sell and ship them abortion pills; and government officials who want to see them be able to get abortions in the middle of a worldwide health crisis. And it is only “time-sensitive” in the sense that it will become a riskier later term abortion procedure IF a woman and her medical adviser are determined to go through with the abortion rather than let the baby be born.

The truth is that “telemedical abortions” would expose the worst and most dangerous features of chemical abortions. Besides potentially making a woman go through this horrific procedure all alone, encountering her child, unsure of whether her pain and cramping and bleeding are normal or whether she is bleeding to death, she also faces the prospect that the pills will not work. They fail anywhere from 2-7% of the time, and more often in the case of older unborn babies.

Outcomes such as these, real possibilities, mean that she may have to return to the clinic or show up at the Emergency Room for additional pills or treatment, where contagion is rampant, where staff are overextended and stressed – the last place an immuno-compromised person wants to be.

Much better, in the time of pandemic, for the mother and child to stay safe, the mother at home and the child alive and growing in her womb.