Health & Fit: Biden’s FDA Throws Abortion Pill Providers Under the Bus

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Dr. Franz Theard prepares doses of mifepristone, the abortion pill, in his New Mexico clinic in May.

Dr. Franz Theard prepares doses of Mifepristone, the abortion pill, in his clinic in Santa Teresa, New Mexico on May 7, 2022. Theards clinic, Womens Reproductive Clinic, is a provider of abortion pills to mostly women from Texas, where abortion is largely illegal once embryonic cardiac activity can be detected due to Texas Senate Bill 8. Paul Ratje/The Washington Post via Getty Images © Photo: Paul Ratje/The Washington Post (Getty Images) Dr. Franz Theard prepares doses of Mifepristone, the abortion pill, in his clinic in Santa Teresa, New Mexico on May 7, 2022. Theards clinic, Womens Reproductive Clinic, is a provider of abortion pills to mostly women from Texas, where abortion is largely illegal once embryonic cardiac activity can be detected due to Texas Senate Bill 8. Paul Ratje/The Washington Post via Getty Images

President Joe Biden promised a “whole of government” response to attacks on abortion last fall, but now, instead of pushing to expand access to medication abortion, the Food and Drug Administration is using the press to condemn doctors who prescribe abortion pills to patients before they’re pregnant.

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An anonymous FDA spokesperson told Politico that the agency is concerned about prescribing abortion pills under “advance provision,” saying that providers may not be able to oversee when patients take the drugs and ensure safety and effectiveness. The spokesperson said that the agency is concerned about people taking abortion pills later than the FDA-approved limit of 10 weeks into pregnancy—though the World Health Organization OKs use for up to 12 weeks.

“​​Mifepristone is not approved for advance provision of a medical abortion,” said the FDA spokesperson, whom Politico granted anonymity to “describe sensitive agency policies.”

The drugs—mifepristone and misoprostol—work together to induce a miscarriage, but the FDA tightly regulates mifepristone. Medication abortion, with or without medical supervision, is the most popular abortion method in America. The abortion pill service Aid Access has offered advance provision of the pills since last fall, after Texas’s bounty-hunter law went into effect and before the Supreme Court overturned Roe v. Wade. Other providers, including Choix, have begun offering advance provision as well. Research published on Tuesday found that requests for abortion pills more than doubled across 30 states since Roe was overturned in June. The largest increase in demand came from states that have banned or severely restricted abortion.

How do mifepristone and misoprostol work?

  How do mifepristone and misoprostol work? A gynecologist explains how the abortion pill works and what mifepristone and misoprostol do to the body. Medication abortion is approved by the Food and Drug Administration for up to 10 weeks into pregnancy, but there is good literature that has shown it is an effective method of abortion up to 11 weeks. This means the majority of people seeking abortion services are able to get medication abortions, Dr. Deborah Bartz, a gynecologist at Brigham and Women's in Boston, told ABC News in an interview.

Dr. Jamila Perritt, an abortion provider and the president and CEO of Physicians for Reproductive Health, said in a statement that the FDA’s position is misinformed. “As an abortion provider, I am disappointed by the FDA’s medically unfounded concern around the advanced prescription of mifepristone,” Perritt said. “Abortion in all of its forms, including medication abortion, is extremely safe. These unnecessary restrictions and groundless concerns regarding the use of mifepristone and access that is needed amidst the continued attacks on our communities creates greater barriers to care and harm.”

“The FDA should follow the science and the medical evidence which supports decreasing barriers to accessing medication abortion, not increasing them,” she said.

The anonymous spokesperson also told Politico the agency is worried about self-managed abortions with pills when it comes to ectopic pregnancies, which form outside the uterus (and are thus not affected by abortion pills). However, even the American College of Obstetricians and Gynecologists, the leading OB/GYN professional association, opposes mandatory in-person exams before and after medication abortions. Patients will know their pregnancy has ended because their pregnancy symptoms stopped, and they will often be advised to take a pregnancy test two to four weeks after the abortion to confirm.

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The ACOG has called for the FDA to remove all remaining restrictions on mifepristone in order to improve access to the drug for people who want to have medication abortions, as well as people experiencing incomplete miscarriages. In a 2018 position statement, ACOG said that both the FDA’s Risk Evaluation and Mitigation Strategy (REMS) and Elements to Assure Safe Use (ETASU) requirements for mifepristone are “outdated” and “substantially limit access to this safe, effective medication.” The group urged the removal of both restrictions. In December 2021, the FDA removed the requirement that the drug be dispensed in-person—permanently permitting prescriptions via telemedicine—but let the other restrictions remain. However, in effect, that changed nothing for people in red states, where laws ban telemedicine prescriptions for abortion pills.

Politico mentioned ACOG’s positions on the remaining restrictions, but did not appear to contact the organization for comment. In a statement to Jezebel, Jen Villavicencio, lead for equity transformation at ACOG, called the current rules surrounding mifepristone “burdensome” and “unnecessary,” and said: “The FDA’s REMS requirements for mifepristone do nothing to enhance the safety of what is already a safe, effective medication, and we oppose any burden on the ability of clinicians to make evidence-based decisions in alignment with evidence-based needs.”

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