Abortion pill is 'imminent' public health danger, FDA warned

CNA Staff, Jul 29, 2020 / 08:00 am

Pro-life leaders have asked the head of the Food and Drug Administration (FDA) to remove the abortion pill from the U.S. market, in a letter sent on Tuesday.

The letter was signed by nearly two dozen pro-life leaders. They urged FDA commissioner Stephen Hahn to exercise statutory authority and classify the abortion pill mifepristone  as a public health hazard, in the face of attempts by abortion advocates to stop FDA regulations of the abortion pill regimen during the pandemic.

"We urge you to protect American women and preborn children by removing the abortion pill (mifepristone) from the US market," said the letter, first reported by National Review. 

Signers of the letter include Marjorie Dannenfelser, president of the Susan B. Anthony List; Jeanne Mancini, president of March for Life; Catherine Glenn Foster, president and CEO of Americans United for Life; Ryan Bomberger, co-founder of the Radiance Foundation; and Russell Moore, president of the Southern Baptist Ethics and Religious Liberty Commission.

They urged Hahn to invoke statute 21 CFR § 2.5 and list the abortion pill as an  "imminent hazard to the public health" that poses a "significant threat of danger." The rule gives the FDA the authority under the Federal Food, Drug, and Cosmetic Act to declare a product or practice poses an immediate threat to public health due to evidence.

The letter comes two weeks after a federal judge overruled FDA requirements that women visit with a doctor in-person before they can be prescribed the abortion pill.

Abortion advocates pushing for the regulations to be lifted are "using the coronavirus pandemic as a ruse," Tuesday's letter stated.

The FDA requirement is part of its Risk Evaluation and Mitigation Strategy (REMS) protocol, reserved for drugs and procedures that are considered higher-risk. Pro-life leaders have been pushing for the FDA to keep its REMS protocol on the abortion pill, and to enforce existing bans on the sale of abortion drugs over the internet.

"According to the FDA's adverse event reporting system, the abortion pill has resulted in over 4,000 reported adverse events since 2000, including 24 maternal deaths," the letter said, and this number is likely an undercount as "[a]dverse events are notoriously underreported to the FDA."

Side effects that women suffer from the pill such as heavy bleeding, abdominal pain, or severe infections are usually treated at emergency rooms which are not required to report the incidents to the FDA.

The FDA's case against the American College of Obstetricians and Gynecologists (ACOG), which challenged the enforcement of the in-person doctor visit requirement during the pandemic, is currently in a Maryland district court.

The FDA argues that the ACOG lacks third-party standing to bring the case on behalf of women, and has not proved that its regulations would not pose a substantial obstacle on women seeking abortions.