The Supreme Court asked to keep access rules for abortion pills

(Allen G. Breed / Associated Press)

The Supreme Court asked to keep access rules for abortion pills

Health&Wellness

MARK SHERMAN and JESSICA GRESKO

April 14, 2023

The Biden administration and a drugmaker on Friday asked the Supreme Court to keep access to an abortion drug free of restrictions imposed by lower court rulings as a legal battle continues.

The Justice Department and Danco Laboratories filed their emergency petitions with the Supreme Court less than two days after an appeals court ruling in a Texas case that tightened the rules under which the drug, mifepristone, can be prescribed and provided.

The new limits would go into effect on Saturday unless the court acts before then.

The mifepriston battle lands in the Supreme Court less than a year after conservative justices Roe v. Wade, effectively allowing more than a dozen states to completely ban abortion.

The judges are being asked for a temporary injunction to enforce the Food and Drug Administration’s regulations regarding mifepristone. Such an order would give the court time to more fully consider both sides’ arguments without the pressure of a deadline.

A ruling from the US 5th Circuit Court of Appeals late Wednesday would prevent the New York company’s pill, used in the most common method of abortion, from being mailed or prescribed without an in-person visit to a doctor. It would

tiltretract

the FDA approval of mifepristone for use after the seventh week of pregnancy. The FDA says it’s safe for up to 10 weeks.

DeSantis signs Florida law banning abortion after six weeks of pregnancy

Yet the appeals court did not quite do so

nullify withdrawal

FDA approval of mifepristone as battle continues. The 5th Circuit narrowed an April 7 ruling by U.S. District Judge Matthew Kacsmaryk, whose far-reaching and virtually unprecedented order

residential blocked

FDA approval of the pill. He gave the administration a week to appeal.

attentive General Merrick Garland said Thursday that the 5th Circuit did not go far enough to protect Americans’ access to safe and effective reproductive care.

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.

Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified its own order from last week to make clear that the FDA must do nothing that could block the availability of mifepristones in 17 Democrat-led states to to hold the market.

Its unclear how FDA can comply with court orders in either case.

The Texas lawsuit was brought by the Alliance Defending Freedom, a conservative legal group that also advocated Roe vs. Wade and representing anti-abortion doctors and medical organizations.

Alliance lawyers said Thursday they had no plans to appeal that could reinstate Texas

Courts

full verdict on this point, indicating that they were satisfied

the

outcome of appeal.

Court reserves access to abortion medicine, but only for 7 weeks and not by mail

The 5th Circuits’ decision is a major victory for the physicians we represent, women’s health and every American who deserves an accountable federal government that acts within the bounds of the law, said Erin Hawley, an attorney for Alliance Defending Freedom.

The two justices who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of the former president

Donald

Trump. The third judge, Catherine Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely for the time being to allow for oral arguments in the case.

The appeals court judges noted in majority in Wednesday’s decision that the Biden administration and the manufacturer of mifepristones warn us of significant public consequences that would ensue if mifepristone were completely withdrawn from the market under the ruling of the lower court.

But the judges suggested that changes by the FDA that made mifepristone more readily available since 2016 were less drastic than the drug’s initial approval in 2000. It would be hard to argue that the changes were so critical to the public, as the nation operated and mifepristone was administered to millions of women without them for 16 years, the judges wrote.

The use of medication for abortion increased significantly after the 2016 rule expansion, according to data collected by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medical abortion accounted for 39%

per cent

of abortions;

But

by 2020

it had increased to

has become the most common method, accounting for 53% of all abortions.

Experts have said the use of medication for abortion has increased since the court overturned Roe.

When the drug was initially approved, the FDA restricted its use to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious effects from the drug.

If the appeals court’s action holds, those would again be the terms under which mifepristone could be provisionally dispensed.

California stockpiles misoprostol misoprostol after court ruling in Texas

At the heart of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency had not adequately assessed the safety risks.

Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning drug approvals, the latest ruling still poses a strong challenge to the FDA’s authority over how prescription drugs are used in the US. The panel overturned multiple decisions by FDA regulators after years of scientific scrutiny.

Common side effects of mifepristone include cramping, bleeding, nausea, headache, and diarrhea. In rare cases, women may experience excessive bleeding that requires surgery to stop.

Still, when FDA regulators eased restrictions on mifepristone, they cited extraordinarily low rates of serious side effects.

According to the FDA, by June 2022, more than 5.6 million women in the US had taken the drug. During that time, the agency received 4,200 reports of complications in women, or less than one-tenth of 1% of women taking the drug.

Associated Press writers Paul Weber in Austin, Texas, and Lindsay Whitehurst in Washington contributed to this report.

LEAVE A REPLY

Please enter your comment!
Please enter your name here

spot_imgspot_img

Hot Topics

Related Articles