In abortion pill case, US high court may undermine drug regulator

Mar25,2024



Washington: If the US Supreme Court, which on Tuesday hears a sensitive case on the availability abortion pillsultimately decides to restrict their access, it would impinge on the scientific authority of the Federal Food and Drug Administration in unprecedented and consequential ways.
While the matter specifically relates to access mifepristone – the first of two pills used in medication abortion – a sweeping ruling could threaten access to many other drugs used for a wide variety of conditions, experts tell AFP.
The mifepristone pill, first authorized by the FDA in 2000, is now used in about two-thirds of abortions in the United States. It has been deemed safe and legal in dozens of other countries.
In 2016, the FDA relaxed some restrictions on the drug's distribution, allowing it to be prescribed during the first 10 weeks of pregnancy (up from seven); permission of health practitioner Not only doctors but also nurses are involved in writing it; And only one consultation is required, less than the previous three.
Then, when the COVID-19 pandemic hit, the FDA allowed pills to be sent by mail, after a single online medical visit.
But after a group of anti abortion doctor And after organizations sued claiming the drug is unsafe and the approval process flawed, an appeals court last year ordered the FDA to return to pre-2016 standards.
The Supreme Court will hear the case on Tuesday.
“For a judge to second-guess the FDA's expert determination is inappropriate, it's unprecedented, and it's also extremely dangerous,” Liz Borkowski, a public and women's health expert at George Washington University, told AFP.
He said, “We could see frivolous litigation against all kinds of drugs that people have been using safely for years” — including potentially contraceptives, vaccines or hormonal therapies — just because some organization opposes them. We do.
– Black robe vs white lab coat –
Since its creation, the FDA, whose decisions are often followed by other countries, has been charged with determining the effectiveness and safety of new drugs. It regularly convenes independent experts as part of a carefully regulated review process.
Lewis Grossman, a lawyer who filed a brief in the case with the Supreme Court, said courts have questioned some of the FDA's decisions, particularly on patent interpretation.
But “to ban the availability of a drug based on disagreement with scientific experts at the FDA,” he told AFP, “would be pretty unprecedented.”
He added, “Explaining science is not a legal act.”
Anti-abortion plaintiffs argue that when the FDA was reviewing its regulations in 2016, it should have studied the impact of all the changes together – an approach that Grossman called “just a fabricated requirement by the plaintiffs.”
Borkowski said: “We have decades of evidence about the safety and efficacy of mifepristone.
“If mifepristone can't stay on the market as it is, despite all the evidence we have, then no drug is safe.”
– Drug manufacturers worried –
pharmaceutical industry strongly opposes judicial intervention in this matter.
If the appeals court's decision is confirmed, it would “create an intolerable level of uncertainty.” drug approval process“According to a brief jointly filed by dozens of pharmaceutical companies and authorities.
And, the brief argues, the effect would be to “cut drug development and investment, and chill innovation”.
The court's decision could also open the door for drugmakers to sue the FDA to prevent rivals from marketing competing drugs, experts said.
According to Grossman, high court involvement in rulemaking could also risk overturning a wide range of agency decisions regarding environmental scientific assessments, workplace safety, or many other issues.
Borkowski believes the court should take a firm stance in the opposite direction, stating clearly that “it is never okay for judges to inject themselves into science.”
However, she acknowledged that given some of the conservative court's recent decisions, she is concerned about the outcome.
Notably, the court overturned long-standing federal protections in 2022 abortion rightsIt is left up to each of the country's 50 states to pass their own laws on the matter.
Since then, about 15 Republican-led states have banned abortion — including the use of abortion pills. However, for now, women in those states can still get them — by mail.
The decision is expected by summer.



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