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Twelve Democratic-led states have sued the Food and Drug Administration to challenge certain federal restrictions imposed on the distribution of the abortion pill mifepristone, saying those limits usually are not supported by evidence.
The lawsuit, led by Washington state and Oregon, was filed on Thursday in federal court in Yakima, Washington and goals to expand access to mifepristone by allowing it to be prescribed and distributed by any doctor or pharmacy, like most drugs. Currently, doctors who prescribe mifepristone, and pharmacies that dispense it, must obtain a special certification.
Meanwhile, a separate lawsuit by anti-abortion activists that seeks to finish access to the drug is proceeding in Texas.
Mifepristone, together with the drug misoprostol, was approved in 2000 by the FDA for medication abortion in the primary 10 weeks of pregnancy. Medication abortion accounts for greater than half of U.S. abortions.
Medication abortion has drawn increasing attention for the reason that U.S. Supreme Court last 12 months reversed its landmark 1973 Roe v. Wade ruling that had legalized abortion nationwide. The choice enabled greater than a dozen Republican-led states to adopt recent abortion bans.
“The federal government has known for years that mifepristone is protected and effective,” Washington state Attorney General Bob Ferguson said on Friday in a press release announcing the lawsuit. “Within the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk. The FDA’s excessive restrictions on this vital drug haven’t any basis in medical science.”
The lawsuit said mifepristone is “safer than many other common drugs FDA regulates, equivalent to Viagra and Tylenol.”
The opposite states which might be a part of the lawsuit are Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, Recent Mexico, Rhode Island and Vermont.
An FDA spokesperson declined to comment on the lawsuit.
Anti-abortion activists have asked a federal judge in Texas to order mifepristone off the market nationwide, arguing that the FDA used an improper process to approve the drug and didn’t adequately consider its safety for minors.
Along with difficult the FDA’s restrictions on how the drug is made available, the Democratic-led states are asking the court to rule that the agency’s approval of mifepristone is lawful and valid, potentially organising a conflict with any order within the Texas case that will require federal appeals courts to weigh in.
The FDA’s special restrictions on mifepristone are imposed under a security program meant to attenuate the chance of doubtless dangerous drugs. The agency has relaxed those restrictions several times since they were first imposed, most recently in January when it allowed certified retail pharmacies to dispense mifepristone.
After last 12 months’s Supreme Court ruling, President Joe Biden directed federal agencies to expand access to medication abortion. Vice President Kamala Harris defended mifepristone on Friday after meeting with reproductive rights groups on the White House, calling attacks against it an try and attack fundamental American rights.