The Food and Drug Administration (FDA), according to a group of 12 Democratic-led US states, is impeding access to a common abortion pill.
Mifepristone was approved in 2000 with restrictions to ensure its safe use. It is one of two drugs used to induce abortions.
The states asserted that the limits on the drug are unsupported by evidence in a lawsuit they filed on Thursday.
In the US, medication abortions are the most prevalent type of the procedure.
Since the US Supreme Court struck down the right to an abortion on demand across the country last summer, it now accounts for more than half of all abortions performed in the nation and is the target of growing political attacks.
A group of conservative anti-abortion activists filed their own lawsuit in November to contest the drug's approval.
When used in conjunction with another medication, misoprostol, mifepristone is thought to be both extremely safe and highly effective for ending pregnancies within the first 10 weeks.
However, the FDA has strict restrictions on who can prescribe and dispense mifepristone, whereas misoprostol is freely available.
According to the Democratic lawsuit, this has led to "burdensome restrictions" on a drug that is the "gold standard" for abortions and has a strong safety record.
The states of Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont are represented by the lawsuit, which was filed in federal court.
The plaintiffs stated in their letter that "the availability of medication abortion has never been more important," adding that the drug's approval was "based on a thorough and comprehensive review of the scientific evidence.".
However, because of the drug's restrictions, it is now "harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome.". to distribute.
Abortion opponents claimed in their own lawsuit late last year that the drug's strict regulation is proof that it is harmful to women and young girls.
The FDA allegedly overstepped its bounds by approving the drug "without basis" and "has spent decades removing what few protections were initially in place," according to the legal advocacy group Alliance Defending Freedom.
In its lawsuit, the FDA is urged to completely remove mifepristone from the market.
