Abortion Drug Approval

Abortion Drug Approval in Limbo: Legal Battle Heats Up in Washington State

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A legal conflict over a drug used in medication abortions has put the FDA’s authority to approve and regulate medications in jeopardy. A federal judge in Washington state ruled that mifepristone is safe and effective, ordering the FDA to preserve access to the pill in the 17 states and Washington, D.C., that sued to protect medication abortion. However, in Texas, another federal judge sided with anti-abortion groups, blocking the agency’s approval of mifepristone.

The conflicting opinions may lead to a legal showdown before the conservative Supreme Court that overturned the constitutional right to an abortion last June, which could potentially permanently undermine the FDA’s authority to vet and approve drugs.

The long-awaited Texas ruling comes nearly five months after an anti-abortion group filed a lawsuit asking the conservative judge to rescind the approval of mifepristone, one of two drugs used in medication abortions. The FDA has promised to appeal the decision.

If the high court were to uphold the ruling handed down by U.S. Judge Matthew J. Kacsmaryk in Texas, it could give courts the power to invalidate almost any FDA approval, scholars warn. This could lead to uncertainty in the pharmaceutical industry, with manufacturers not assured of a uniform market for their drugs based on FDA approval.

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