States says pulling FDA approval would be ‘devastating’

The attorneys general from 21 states and Washington, D.C., on Friday argued that the attempt to pull the abortion pill from the U.S. market would have “devastating consequences” for women.

The filing in federal district court in Texas comes in response to a lawsuit by anti-abortion physicians who have asked that court to overturn the Food and Drug Administration’s two-decade-old approval of mifepristone.

The attorneys general argued that overturning the FDA approval would make the pill largely unavailable, forcing women to either undergo a more invasive surgical procedure or forgo abortion altogether.

Surgical portion is also more costly and difficult to obtain, they argued, which would disproportionately impact women who are lower-income, underserved or live in rural communities where there might not be access to a clinic.

“This would have devastating consequences,” the attorneys general told Judge Matthew Kacsmaryk, who is presiding over the case in the U.S. district court in Northern Texas.

The abortion rights group NARAL Pro-Choice America, in an analysis published Friday, said 40 million women would lose access to the abortion pill if the court overturns the FDA’s approval.

Used in combination with misoprostol, mifepristone is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions.

Kacsmaryk on Thursday extended a key deadline in the case. He ordered one of the abortion pill makers, Danco Laboratories, to lay out its opposition to the lawsuit. The anti-abortion physicians who brought the case then have until Feb. 24 to respond.

“Forcing FDA to withdraw a longstanding approval would seismically disrupt the agency’s governing authority as to whether drugs are safe and effective, and would cause Danco direct and immediate harm by shuttering its business,” the attorneys for Danco Laboratories told the court on Friday.

Mifepristone has become the central focus in the battle over abortion access since the Supreme Court overturned Roe v. Wade last June.

New York led the coalition of state attorneys general and Washington, D.C. in arguing to keep mifepristone on the market. The other states included California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Washington and Wisconsin.

The FDA last month changed its regulations to allow certified retail pharmacies to dispense mifepristone. CVS and Walgreens, the nation’s two largest drugstore chains, have said they are getting certified to dispense the prescription medication in states where it’s legal to do so.

Republican attorneys general warned the companies against distributing the pill by mail in their states, indicating that they would take legal action.

There are also lawsuits seeking to overturn state restrictions on mifepristone, arguing that they conflict with FDA regulations. GenBioPro, the other abortion pill manufacturer, is suing to overturn West Virginia’s ban. A physician in North Carolina is challenging that state’s restrictions.