The Biden administration has asked the Supreme Court to restore full access to an abortion drug after a lower court imposed restrictions on its use.
The Department of Justice (DOJ) filed an emergency appeal to restore access to mifepristone, the drug used in more than half of all US abortions.
The case has nationwide ramifications not only for millions of women but also for the future of drug approvals.
Last week, a Texas court ordered pulling the drug off the market.
The justice department is seeking to remove restrictions on the drug, which had been imposed by a lower appeals court, pending their review of the Texas court ruling.
While keeping the drug on the market, the appeals court barred patients from receiving it by mail and shortened the window for mifepristone’s approved use, from up to 10 weeks of pregnancy to seven.
In its appeal to the Supreme Court, the DOJ says the Texas court’s ruling would lead to “regulatory chaos”. It has urged the country’s top court to restore the status quo, effectively canceling the Fifth US Circuit Court of Appeal’s additional restrictions.
Mifepristone was first approved by the US Food and Drug Administration (FDA) more than 20 years ago. The drug is part of a two-drug regimen that induces abortions – it effectively stops the pregnancy, while the second drug, misoprostol, empties the uterus.
But on 7 April, Texas court Judge Matthew Kacsmaryk ruled the FDA had violated federal rules that allowed for the accelerated approval of some drugs, and had erred in its scientific assessment of the drug.
The appeals court put a hold on this ruling but also imposed additional limits on the drug.
In this latest move, the justice department has asked the country’s top court to strike down these limitations, which were set to take effect on Saturday.
Experts say the legal fight will have far-reaching implications for both abortion access and drug regulation in the United States.
“We are in unprecedented territory,” Areta Kupchyk, a former FDA associate chief counsel, told the BBC, saying she could not recall a single another example of the FDA being forced to withdraw approval for a drug long considered safe for use.
Anti-abortion campaigners who have opposed mifepristone’s FDA approval claimed the agency made a politically motivated decision in approving the drug, and said it did not follow proper protocols.
Kristi Hamrick, spokeswoman for the anti-abortion organisation Students for Life of America, applauded the Texas ruling, calling it an “evidence-based rejection” of poor safety standards used to regulate abortion pills.
The FDA spent four years reviewing mifepristone before it was approved in 2000, and placed the drug in a select category of just 60 drugs that is regulated under a system of extra restrictions, which are repeatedly re-evaluated.
Its safety and effectiveness are supported by mainstream medical organisations including the American College of Obstetrics and Gynaecologists (ACOG) and the World Health Organisation (WHO).
“It is deeply concerning that appellate judges think they can micromanage FDA decisions for mifepristone and other FDA approved drugs,” said Lawrence Gostin, a lawyer and professor of global health law at Georgetown University. “These are scientific decisions that should not be made by lay judges.”
Mr Gostin told the BBC he hoped the Supreme Court would rule in favour of the FDA but that “all bets were off” with the current bench, where conservative justices hold a 6-3 supermajority.
And it is so far unclear how a duelling ruling out of Washington, which ordered the FDA to keep mifepristone on the market in 17 Democratic-run states, may effect this recent development.
Mr Gostin said the Fifth Circuit should only have control on the states in its jurisdiction – Alabama, Florida, Georgia, Texas, Louisiana and Mississippi – meaning the new rules would only apply in those six states.
Source: www.bbc.com
