Court reserves access to abortion medicine, but only for 7 weeks and not by mail
PAUL J.WEBER and JESSICA GRESKOApril 12, 2023
A federal appeals court has allowed access to an abortion drug for now, but under stricter rules that restrict the drug to dispensing for up to seven weeks
in pregnancy
not 10, and not by mail.
The drug, mifepristone, was approved for use by the Food and Drug Administration more than two decades ago. It is used in combination with a second drug, misoprostol. The 5th US Circuit Court of Appeals in New Orleans ruled just before midnight on Wednesday.
and the case can now be taken to the US Supreme Court
.
By a 2-1 vote, a panel of three judges
from an appeals court known for its conservatism
narrowed down for now a decision by a lower court judge in Texas that completely blocked FDAs approval of the drug after a lawsuit by mifepristone opponents.
The lower court ruling has been on hold for a week to allow for appeal.
According to the appeals court order, the initial FDA approval of mifepristone in 2000 may remain in effect.
But changes the FDA has made since 2016 to relax the rules for prescribing and dispensing mifepristone would be put on hold. Those include extending the pregnancy period in which the drug can be used and allowing it to be delivered by mail without the need to visit a doctor’s office.
The two justices who voted to tighten the restrictions, Kurt Engelhardt and Andrew Oldham, are appointees of former President Trump. The third judge, Catherine Haynes, is an appointee of former President George W. Bush. She said she would temporarily put the lower court ruling on hold entirely to allow for oral arguments in the case.
Either side can take the case from the appeals court to the Supreme Court. Opponents of the drug can try to have the lower court’s full ruling stand. Meanwhile, the Biden administration could ask the Supreme Court to allow all FDA amendments to remain in effect as the case unfolds. The majority of the appeals court judges noted that the Biden administration and the manufacturer of mifepristones warn us of significant public consequences if mifepristone were completely withdrawn from the market under the lower court ruling. But the judges suggested that changes the FDA made that made mifepristone easier to obtain 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 had been administered to millions of women for sixteen years without them, the judges wrote. When the drug was first approved in 2000, 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 claim holds, those would again be the conditions under which mifepristone could be provisionally dispensed.
Democratic leaders in states where abortion remains legal since the Supreme Court’s Roe v. Wade last year, including California, say they are preparing in case mifepristone is restricted.
Government of New York. Kathy Hochul said on Tuesday that her state needs 150,000 doses of misoprostol, the
second
medicine used in
two pill
medication abortion.
Pharmaceutical executives also signed a letter this week condemning the Texas ruling and warning that FDA approval of other drugs could be jeopardized if U.S. District Judge Matthew Kacsmaryk’s decision stands. There is virtually no precedent for a lone judge overturning FDA medical recommendations.
The lawsuit against mifepristone’s approval was brought by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to the Supreme Court’s Dobbs ruling, which ruled Roe v. Wade destroyed. At the heart of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately assess its safety risks.
Mifepristone has been used by millions of women over the past 23 years, and complications from its use are less common than problems associated with wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.