Friday, April 12, 2024

The Supreme Court has delayed its abortion pill decision


legal saga About the abortion pill mifepristone isn’t over yet. On Wednesday, the US Supreme Court extended its deadline to decide on the fate of the drug until Friday Eastern Time just before midnight.

This tablet will remain in the market for at least the next few days. Supreme Court’s decision on access to the pill will be the most important decision on reproductive rights since the court overturned Roe v. Wade In June 2022.

Approved by the US Food and Drug Administration in 2000, mifepristone is the first dose in a two-pill regimen to induce abortion in the first trimester. In recent years, the FDA has taken measures to make it more accessible, including making it available by mail and allowing patients to take the drug up to 10 weeks of pregnancy. medication abortion account for now A little more than half of abortions in America,

On April 7, US District Judge Matthew Kaczmarik of Texas ruled to rescind the FDA’s approval of mifepristone and make it illegal nationwide, writing that the drug is unsafe and that its authorization in 2000 was rushed. However, more than 100 studies over several decades Show that the Pill is safe and effective in terminating pregnancies in the first trimester.

Last week, the 5th Circuit Court of Appeals struck down Kacsmaryk’s ban but upheld a ban on the drug, which has not been in place since 2016, when the FDA began loosening access to mifepristone. The three-judge panel said the pill could remain available, but it must be given individually and can only be taken for the first seven weeks of pregnancy. These regulations threaten the FDA’s authority to evaluate and approve drugs, especially those considered politically controversial.

The Justice Department, acting on behalf of the FDA, asked the Supreme Court to keep the pill available. On April 14, Justice Samuel Alito stayed the decisions until the High Court could consider the issue.

GenBioPro, which makes a generic form of mifepristone, filed a lawsuit against the FDA on Wednesday in an effort to keep the drug available. In the suit, the company argues that if the FDA were to comply with court orders restricting access to the pill, it would violate laws that guide the process of withdrawing an already approved drug.

Many drugs have been pulled from the market, either because of risk to patients or for commercial reasons such as low demand. But no court has suspended FDA approval of a drug before.

Even if the Supreme Court favors the Kaczmarik decision and withdraws the drug’s approval, there is a scenario in which mifepristone may remain in the market. According to Alison Whalen, assistant professor of law at Georgia State University, the FDA can continue to allow access to the drug by exercising a policy called “enforcement discretion,” which means it will not prosecute manufacturers or distributors.

But while the current FDA leadership may choose to exercise its enforcement discretion, a future presidential administration could always reverse course. “I don’t see any real stability for medication abortion in the short term, potentially longer term as well,” Whelan says.