“Medical malpractice” is how a panelist described the failure of the U.S. Food and Drug Administration (FDA) to monitor the removal of abortion pill safeguards, 11 in total, since 2016.
The panel discussion, titled “Abortion Pills: What’s Next?” was livestreamed by the Heritage Foundation on November 13, as a case before the U.S. Supreme Court could determine the regulation and mailing of abortion pills.
The panel featured Christina Francis, M.D., Erik Baptist, an attorney for the public interest law firm Alliance Defending Freedom, and U.S. Rep. Bob Good (R-VA), and was moderated by Sarah Parshall Perry, a Heritage senior legal fellow. The panel members explored different aspects of the fight to regulate abortion pills in a post-Dobbs-decision environment.
The availability of abortion pills by mail effectively makes abortion legal even in the states with the most pro-life laws.
Why Restrict Abortion Pills?
Chemical abortions typically consist of a two-pill series of mifepristone and misoprostol. Pro-life advocates say that allowing the drugs to be prescribed in advance to women who are not pregnant, and the mailing of the drugs, will remove important safeguards that protect women’s health.
Perry asked Francis, CEO of the American Association of Pro-Life Obstetricians and Gynecologists and a member of Abortion Pill Rescue Network if the abortion industry’s claim the pill is as safe as Tylenol is accurate.
“Absolutely not,” said Perry. “I can confidently say that I’ve never been called to the emergency room to take care of a Tylenol complication, and I have been called to the emergency room many, many times to take care of complications of these drugs.”
“The FDA does not do a good job of capturing these complications. They’re very difficult to report to the FDA,” said Francis, who made the “medical malpractice” comment.
Perry said high-quality studies show “emergency room visits may be as high as 35 percent of women who take these drugs,” and that isn’t comparable to the effects of Tylenol.
Suing the FDA
“When FDA approved the drug in 2000, the agency recognized that there were some dangers inherent with mifepristone,” said Baptist, a counsel for the Alliance for Hippocratic Medicine in its lawsuit against the FDA, which is now before the U.S. Supreme Court.
Baptist walked the panel through how the safeguards the FDA had included upon mifepristone’s approval have slowly been “stripped away.”
For example, patients used to need three in-person doctor visits, in which the expectant mothers were screened for life-threatening conditions and other complications. The doctor would also “make sure the woman takes the drug at the appropriate time and in the appropriate manner,” said Baptist.
“The FDA got rid of two of those three doctor’s appointments,” said Baptist, in addition to allowing abortion pills to be ordered by mail. “That’s dangerous, again, because now you’re going to have no doctor involved. You’re not going to have any medical professional screening the woman before receiving these drugs,” said Baptist.
In August, a federal appeals court ruled the protections must be restored as a condition of keeping mifepristone on the market.
Ultimately, the Supreme Court may rule on whether mifepristone must be pulled from the market completely. Oral arguments are scheduled for early 2024.
Meanwhile, three red states are also suing the FDA, building on precedent from that lawsuit.
Can Congress Restrict Abortion?
Good told the panel Dobbs did not leave the question of abortion legality to the states.
“If you read the Dobbs decision, it turned it over to the people and the states, which means their elected representatives in Washington and in their respective states,” said Good. “So, it doesn’t require Congress to regulate abortion, but it does give Congress again the rightful ability to do that.”
Sen. Rand Paul (R-KY) introduced the Life at Conception Act, which would extend 14th Amendment right-to-life protections to the unborn.
“It’s very concerning, quite frankly, that some of my friends in Congress who were signing onto the Life at Conception Act with me pre-Dobbs decision, many of them became hyper-federalists all of a sudden after Dobbs. …We ought to continue to unashamedly, unapologetically fight for that.”
Good also advocated for the Teleabortion Prevention Act which, he said, would require “that the patient, the mother, would have to have an in-person visit, the physician would have to be present or the medical practitioner during the process, and there would have to be a follow-up,” out of concern for the mother’s health.
State-Level Bans
The abortion pill is effectively banned in 13 states, while in other states, such as Wyoming, lawsuits have prevented enforcement of a ban. In still others, such as Indiana, pressure has led to restriction of the pill’s distribution despite the drug remaining legal.
States like Michigan and Ohio have enshrined abortion rights in law. “There isn’t much that can be done with regard to abortion in general and the abortion pill specifically other than to try to educate people about the humanity of the unborn and the dangers of abortion,” said Genevieve Marnon, legislative director for Right to Life Michigan, in an email to Health Care News.
“We are anxiously awaiting the decision of the 5th Circuit regarding the lawful/unlawful FDA approval of the abortion pill and the subsequent changes in the REMS (risk evaluation and mitigation strategy),” said Marnon. REMS restricts how an approved drug may be used.
“We are hopeful that the case will eventually make its way to the Supreme Court, where they will see that the abortion pill was unlawfully approved in 2000 and will order the removal of the pill from the FDA’s list of approved drugs.”
Harry Painter (harry@harrypainter.com) writes from Oklahoma.
 to monitor the removal of abortion pill safeguards, 11 in total, since 2016.){kind=link}