Report: FDA Concerned Providers Prescribing Abortion-Inducing Drugs for Women Who Are Not Pregnant

Susan Berry, PhD

The Food and Drug Administration (FDA) says abortion providers are prescribing abortion-inducing drugs to women in advance of becoming pregnant – a practice that is without authorization and potentially dangerous for women.

“The FDA is concerned about the advance prescribing of mifepristone for this use,” an anonymous FDA spokesperson reportedly told the German-owned Politico Friday. “Mifepristone is not approved for advance provision of a medical abortion.”

The reported concerns of the FDA place the federal agency at odds with an abortion industry that has fiercely advocated for the lifting of restrictions on first-trimester abortion-inducing drugs, such as mifepristone and misoprostol. Abortion rights activists claimed such an easing was necessary during the pandemic so that women and girls could conduct their own abortions at home or in their college dorms after only a telemedicine chat with an abortion provider.

Politico reported the FDA’s expressed stance “is a rebuke of a prescribing method, advance provision, that has grown as a way to counter states’ abortion restrictions since Roe v. Wade fell this summer.”

“The FDA’s position also puts the Biden administration — the president has publicly pledged to do everything within his power to preserve access to abortion — at odds with some abortion providers and abortion-rights activists,” the reported noted.

The dangers of taking mifepristone, in advance of being pregnant, is that abortion providers could not ensure the drug’s safety and effectiveness, the FDA spokesperson said, according to the report:

[T]he FDA is concerned that if patients were to take mifepristone weeks or months after getting a prescription filled, a medical professional may not be able to assess if a pregnancy is intrauterine or ectopic or date pregnancies properly. The drug is only approved through 70 days’ gestation for abortions.

OB/GYN Dr. Christina Francis told The Star News Network the FDA’s reported concerns are exactly why she and other women’s physicians opposed the FDA’s decision to allow dispensing of the abortion-inducing drugs without an in-person visit.

“While the FDA is rightly condemning the dangerous and untested practice of prescribing mifepristone and misoprostol to someone who isn’t even pregnant, it should be pointed out that the very dangers that the FDA official identifies in this interview – potentially missing an ectopic pregnancy or the chemical abortion drugs being used beyond 10 weeks’ gestation – are exactly the same when these dangerous drugs are dispensed without an in-person visit,” said Francis, a board member and CEO-elect of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG).

“And yet, the FDA endorsed this practice in December 2021 when they revised the prescribing guidelines for mifepristone, permanently removing the in-person dispensing requirement,” she explained, adding:

These very real dangers, in addition to the need for women to be adequately counseled and screened for coercion, as well as have a medical professional with whom they can have follow-up, are all reasons why the in-person dispensing requirement and tracking of all adverse outcomes should be reinstated.

In December 2021, FDA made permanent the removal of the in-person dispensing requirement it had previously allowed for the COVID pandemic duration in April of last year.

Then-Acting FDA Commissioner Dr. Janet Woodcock announced the agency would be lifting restrictions on the health and safety standards applied to abortion-inducing drugs, allowing for the provision of the drugs via telemedicine and through the mail during the COVID crisis.

In an address to the radicalized American College of Obstetricians and Gynecologists (ACOG), Woodcock said only a “small number of adverse events” linked to mifepristone had been found and that no “program deviation or noncompliance” with the mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program “contributed to the reported adverse events.”

Woodcock concluded that, provided the other risk and mitigation strategies for mifepristone are met, FDA “will exercise enforcement discretion during the pandemic “with respect to the dispensing of mifepristone through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy.”

Planned Parenthood, which had lobbied for the easing of restrictions on the abortion-inducing drug, tweeted mifepristone “is safe, effective, and has been used by 4+ million people since the FDA approved it more than 20 years ago.”

“Removing medically unnecessary barriers to it is a big win for abortion access & keeps patients, providers, and health center staff safer during the pandemic,” Planned Parenthood said.

Bloomberg reported in September, however, that abortion telemedicine startup Choix, for example, began selling abortion-inducing drugs to women under the “advanced provision” practice so the drugs could be stockpiled for future use after the Supreme Court overturned Roe and returned the power to restrict abortion to the states.

Choix CEO Cindy Adam objected to the FDA’s concerns, telling Politico restrictions on drug-induced abortion are unnecessary and that her company provides “ongoing supportive” care to patients.

National pro-life leader Abby Johnson, who had a drug-induced abortion and is a former Planned Parenthood director who now runs And Then There Were None, asked in comments sent to The Star News Network, “Does it really make a difference when these women are obtaining the abortion pill, before or after pregnancy?”

“They aren’t seeing a doctor either way,” Johnson observed. “They aren’t having ultrasounds. They aren’t verifying they are pregnant. They aren’t verifying gestational date. They have no idea how old these women are. No medical history is verified. It’s not like the people sending the abortion pills care about the women.”

Pam Whitehead, who runs ProLove Ministries, added:

Every medication has risks. There is no way that Choix or any other clinic or drug manufacturer could guarantee that this regimen is safe for every person. If even one person is at risk of injury or death, then there needs to be restrictions. But the abortion industry is not in the business of caring about even that one person’s life, so of course they would push back on any restriction or boundary for prescribing. You’re putting meds in the hands of individuals who are in crisis and no one can accurately mitigate that risk. The abortion industry believes the benefits (hundreds of millions of dollars) outweigh the risk of injury to women.

In another questionable practice, abortion providers have advised women who are hospitalized or need surgery due to complications from an at-home abortion to deceive doctors treating them by saying they have suffered a “natural miscarriage” instead of admitting to a drug-induced abortion.

In May, the Charlotte Lozier Institute (CLI), the research arm of Susan B. Anthony Pro-Life America, released a study revealing that women and girls who use drugs to induce abortion are exposed to increased health risks when they experience complications.

Results of the study found women presenting to an emergency room with complications related to drug-induced abortions – miscoded as a natural miscarriage – are twice as likely to be admitted for surgery to treat retained products of conception [RPOC] and at significantly greater risk of multiple hospital admissions for treatment of complications.

Dr. Ingrid Skop, CLI’s director of medical affairs, emphasized that claims by abortionists and the abortion industry that a natural miscarriage and an elective abortion are the same “amount to encouraging medical malpractice.”

“Having walked with thousands of women through difficult pregnancies, miscarriage, and even complications from abortion, I know firsthand how difficult it is to talk about these issues,” Skop said. “But I can’t understand why the abortion industry seeks to nullify and even exacerbate a woman’s grief and experience by telling her to conceal important and medically necessary information from her physician. The data is clear. Not telling your doctor that you’ve taken the abortion pill increases your health risks.”

– – –

Susan Berry, PhD, is national education editor at The Star News Network. Email tips to [email protected].

Related posts

Comments