FDA Asks Supreme Court to Reinstate Safety Rule for Abortion Pill

August 27, 2020 Updated: August 27, 2020

The Trump administration is asking the Supreme Court to reinstitute a rule requiring that an abortion-inducing drug be taken in the presence of a medical doctor, after a judge issued a nationwide injunction in July pausing the safety requirement during the current pandemic.

The drug RU486, also known as Mifeprex, is used to end a pregnancy during the first 10 weeks and can cause excessive bleeding, according to the government. Around 85 percent of patients “report at least one adverse reaction” following the use of the drug, the most common being “nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness,” according to studies.

The emergency application in the ongoing litigation, cited as Food and Drug Administration (FDA) v. American College of Obstetricians and Gynecologists, was filed Aug. 26 with the Supreme Court. The other respondents named in the document are the Council of University Chairs of Obstetrics and Gynecology; the New York State Academy of Family Physicians; Atlanta-based SisterSong Women of Color Reproductive Justice Collective; and Honor MacNaughton, a medical doctor in Malden, Massachusetts.

The application, which was referred to Chief Justice John Roberts, remained pending as of press time.

Since the FDA approved RU486 in 2000, the agency has required that it be “dispensed only by or under the supervision of a certified healthcare provider in a hospital, clinic, or medical office, and only after a patient signs a form acknowledging that she has been counseled about the drug’s risks,” acting U.S. Solicitor General Jeffrey Wall stated in a brief filed with the court.

“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.”

Pro-abortion groups say the requirements are outdated and aren’t medically necessary.

In May, the American College of Obstetricians and Gynecologists sued the government in an effort to overturn the rule.

On July 13, U.S. District Judge Theodore D. Chuang of Maryland, who was appointed in 2014 by then-President Barack Obama, issued an order preventing the rule’s enforcement during the pandemic, citing legal precedent and ruling that amid the current public health crisis, it presented a “substantial obstacle” to women’s access to abortion.

“Particularly in light of the limited timeframe during which a medication abortion or any abortion must occur, such infringement on the right to an abortion would constitute irreparable harm,” the judge wrote.

“By causing certain patients to decide between forgoing or substantially delaying abortion care, or risking exposure to COVID-19 for themselves, their children, and family members, the In-Person Requirements present a serious burden to many abortion patients,” Chuang wrote in his opinion.

Chuang has locked horns with the Trump administration before. In early 2017, he issued an injunction partially blocking Executive Order 13780, the second iteration of the president’s temporary travel ban that purported to temporarily deny entry to the United States by people from Iran, Libya, Somalia, Sudan, Syria, and Yemen.

The 4th Circuit Court of Appeals refused to stay Chuang’s ruling about RU486 while the Trump administration appeals.

In the new filing, the administration asked the justices to resurrect the FDA rule during the pendency of the appeal.

“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,” Wall argued.

“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,” Wall wrote in an apparent reference to sweeping nationwide injunctions against government policies.

U.S. Attorney General William Barr has taken aim at the growing trend of unelected federal judges vetoing presidential actions by issuing national injunctions against disfavored policies.

These nationwide or “non-party” injunctions reach beyond the controversy being litigated and, according to critics, allow judges to impose their will in parochial or regional disputes on the entire country.

Officials at the American College of Obstetricians and Gynecologists didn’t immediately respond to a request by The Epoch Times for comment.