A federal judge in Texas could soon order the U.S. Food and Drug Administration to withdraw its approval of abortion pill mifepristone, a move that if allowed to stand could severely undermine the agency, health policy and legal experts said.
The closely followed case could potentially lead to a nationwide ban on mifepristone - part of a two-drug regimen that accounts for more than half of U.S. abortions - and call into question the FDA's power to regulate all drugs nationwide, they said.
A ruling against the agency's approval of a drug over 20 years earlier would be unprecedented and could ripple through drug research and development for years, with implications for public health and access to new treatments. Should the court ban mifepristone sales based on a finding that it's not safe, that would effectively end the FDA's status as the ultimate arbiter on drug safety, experts said.
Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.
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