Lawsuit seeks to reverse FDA’s ‘reckless’ approval of abortion pills
The lawsuit, which was first reported by Media Matters for America (MMfa), seeks to overturn a rule issued by the U.S. Food and Drug Administration by arguing that the FDA should have used a longer and more stringent review process on the abortion pill.
“We’re not trying to stop all abortions, but we are protecting a woman’s right to access safe and legal abortion, which we think should be allowed,” said Dr. David Grimes, CEO of the NARAL Pro-Choice America, in a public statement. “We know this policy, and the FDA process in particular, will put patients at risk.”
The lawsuit follows a similar complaint brought forward by the Christian Medical Association, a national medical group with members from 40 states and two Canadian provinces.
The Christian Medical Association claims that two abortion drugs – RU-486 and mifepristone – should be considered “contraceptive” drug products, thereby making them subject to FDA regulations.
“Mifepristone, as a prescription drug, was only reviewed for a period of two weeks after it became available for sale on the open market,” says the complaint, which was filed in June.
The FDA has responded to the complaint, arguing that the drugs were subject to the same standard as other prescription drugs.
The government’s decision to let RU-486 and Mifepristone remain on the market was “not unreasonable”, and the FDA had no legal obligation to “investigate and regulate the drug” under a “rigorous” standard, according to a letter sent to the National Women’s Health Project by FDA spokesperson Dr. Janet Woodcock this month.
“The FDA could have easily asked a doctor to provide new information to the agency about the drug to help evaluate the safety and effectiveness of RU-486,” said Dr. Michael Carome, president of the NARAL Pro-Choice America, in a statement to Media Matters.
The FDA’s decision to allow RU-