27 Aug

Trump administration petitions Supreme Court to keep FDA abortion pill safeguards in place

via Live Action News August 26, 2020 at 05:27PM

Citing risks to women’s health, the Trump administration has petitioned the Supreme Court of the United States to allow the Food and Drug Administration’s safety requirements regarding the abortion pill to remain in effect after a judge enjoined some of those requirements. A nationwide preliminary injunction was put in place on July 13, 2020, by U.S. District Judge Theodore Chuang for the U.S. District Court for the District of Maryland. That injunction is set to remain in place for the unknown duration of the COVID-19 pandemic.

The injunction halted the FDA’s safety requirement that the first drug in the abortion pill regimen, mifepristone, be distributed at an in-person visit to an abortion provider. As reported earlier this week by Live Action News, abortion clients can now “obtain the abortion pill online and in pharmacies without being seen in person by a health professional during the COVID-19 pandemic.” The requirement was enjoined in response to a “lawsuit, filed on behalf of the American College of Obstetricians and Gynecologists against the FDA assert[ing] that requiring mifepristone to be dispensed to abortion clients in person during the COVID-19 pandemic is an undue burden.”

The Trump administration’s petition disagrees with this assessment, noting, “Given that the surgical methods of abortion remain widely available, the enforcement of longstanding safety requirements for a medication abortion during the first ten weeks of pregnancy does not constitute a substantial obstacle to abortion access, even if the COVID-19 pandemic has made obtaining any method of abortion in person somewhat riskier.”

REMS (Risk Evaluation and Mitigation Strategy) is a drug safety protocol the FDA places on certain drugs that carry a risk of serious complications. The FDA put REMS in place for the abortion pill because of the dangerous risks associated with the two-drug regimen of mifepristone and misoprostol.

Under REMS, women must take the first pill, mifepristone, at the abortion facility under medical supervision and sign paperwork acknowledging that they have been informed of the health risks. Chuang’s ruling allows the abortion pill to be taken by women at home without evaluation for medical conditions such as ectopic pregnancy that put them at higher risk of complications. Additionally, the gestational age of the preborn child cannot be accurately assessed without an ultrasound. This assessment is important because the abortion pill is only approved by the FDA to be taken up to 10 weeks, and the risk for an incomplete abortion increases with gestational age.

The Trump administration argues that “The FDA has made, and continuously adhered to, the judgment that these requirements mitigate serious health risks associated with the drug, which can increase if the patient delays taking the drug or fails to receive proper counseling about possible complications.”

Women who take the abortion pill are at risk for hemorrhage, incomplete abortion, and even death. Since the UK began allowing at-home abortion pill usage beginning in March 2020, two women have died and a 28-week old baby was born alive and later died after the mother took the abortion pill 18 weeks later than safety rules allow.

In addition to concerns about women’s health, the Trump administration’s petition points out that the Supreme Court previously stated that judges should not question how officials deal with public-health concerns, yet one single district judge has managed to undo FDA safety protocols amid a global pandemic.

“This Court has made clear that judges are not to second-guess how officials address public-health concerns in areas of uncertainty, yet the district court dismissed the FDA’s expert judgment in favor of its own view that the safety requirements are medically unnecessary,” states the petition. “And setting the merits aside, the scope of the injunction extends well beyond the district court’s remedial authority under Article III and basic equitable principles.”

As Live Action president and founder Lila Rose noted in a tweet, the Trump administration’s petition is a step in the right direction, though the end goal is to remove the dangerous drugs from the U.S. market altogether.

The abortion industry had already begun pushing for dangerous at-home abortions years ago and COVID-19 has given them the opportunity to accomplish that goal — but it is women and children who will pay the price with their health and lives.

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