Abortion pill is ‘imminent’ public health danger, FDA warned

July 29, 2020 CNA Daily News News Briefs 0 Print

CNA Staff, Jul 29, 2020 / 09:00 am (CNA).- 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.

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Appeals court rejects Biden administration request to enforce ‘gender identity’ Title IX rules

July 19, 2024 Catholic News Agency 0
The U.S. Department of Education sign hangs over the entrance to the federal building housing the agency’s headquarters on Feb. 9, 2024, in Washington, D.C. / Credit: J. David Ake/Getty Images

Washington, D.C. Newsroom, Jul 19, 2024 / 15:22 pm (CNA).

An appellate court rejected a request from President Joe Biden’s administration to enforce a regulation in four states that would broadly prohibit discrimination based on a person’s self-asserted “gender identity.”

The United States Court of Appeals for the 5th Circuit upheld a lower court ruling that prevents the U.S. Department of Education from enforcing any part of the “gender identity” provisions in the Title IX rule for public schools and colleges in Montana, Idaho, Louisiana, and Mississippi. 

The lower court’s order will remain in place as all five states continue their lawsuit, which challenges the legality of the regulation.

Courts have blocked the Department of Education from enforcing the regulation in 15 states altogether, while attorneys general in about a dozen other states have also filed lawsuits. The regulation will go into effect on Aug. 1 in jurisdictions where courts have not blocked its enforcement.

The regulation, which the administration promulgated in April, reinterprets Title IX’s prohibition on “sex discrimination” to include a prohibition on “gender identity” discrimination. 

Some lawyers and Republican attorneys general have warned that the rule would jeopardize state laws that restrict girls’ and women’s locker rooms, bathrooms, dormitories, and athletic competitions to only girls and women and could force states to allow access to men who identify as women.

“The Biden administration’s radical redefinition of sex turns back the clock on equal opportunity for women, undermines fairness, and threatens student safety and privacy,” Alliance Defending Freedom Senior Counsel Natalie Thompson, who is representing the Louisiana-based Rapides Parish School Board in the lawsuit, said in a statement. 

“The 5th Circuit now joins the 6th Circuit in holding back the Biden administration’s illegal efforts to rewrite Title IX while this critical lawsuit continues,” she added. “The administration continues to ignore biological reality, science, and common sense.” 

“The Rapides Parish School Board and schools and teachers across the country are right to stand against the administration’s adoption of extreme gender ideology, which would have devastating consequences for students, teachers, administrators, and families.”

After the lower court blocked the Department of Education from enforcing any part of the rule, the department filed an appeal that requested permission to partially enforce the rule while the litigation continues. The department claimed that the prohibition on enforcement was too broad and requested permission to enforce reporting and record-keeping rules, grievance procedures, and a variety of provisions related to “gender identity” discrimination included in the new rule.

In the ruling, the judges wrote that “the answer is no,” adding that the provisions the department wants to enforce are “complex, lengthy, and burdensome” and that the department “has given us little basis to assess the likelihood of success” in the case.

“The implementation and compliance costs would double if the partially implemented rule differs from a final judgment,” the judges wrote. “They would first have to amend their policies, alter their procedures, and train their employees to comply with a partial version of the rule pending appeal, and then they would have to do it all over again to comply with the rule as it stands at the conclusion of the litigation.”

The prohibition on sex discrimination written into the law itself makes no mention of “gender identity.” When Congress added the Title IX sex discrimination provisions into federal law in the 1970s, the intent was to provide girls and women with equal access to education and did not have any reference to transgenderism.

In spite of this, the Biden administration argues that interpreting “sex discrimination” to include “gender identity” discrimination is within the scope of the Department of Education’s regulatory authority. The states opposed to the rule argue that this interpretation is not consistent with the actual text of the law and falls outside of the department’s regulatory authority.

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