birdwatcher (birdwatcher) wrote,
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Это FDA

On Tuesday, the U.S. Court of Appeals for the D.C. Circuit ruled 8-2 that terminally ill patients who have exhausted all available treatments have no constitutionally protected right to access experimental treatments not yet approved by the federal Food and Drug Administration. A panel of the D.C. Circuit previously had ruled 2–1 in favor of the terminally ill patients who brought the case, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach.

Из заявления в суд: "The challenged policy prohibits mentally competent patients with no other treatment options from purchasing investigational drugs -- medicines showing initial evidence of safety and efficacy in clinical trials, but not yet approved -- even though their physicians recommend these drugs as their best hope of surviving or of prolonging their lives."

The Abigail Alliance is named for Abigail Burroughs, who died of head and neck cancer in 2001 after failed attempts to access Erbitux (cetuximab) through the FDA’s existing channels. (In 2006, the FDA approved Erbitux for treatment of head and neck cancer.) The Abigail Alliance now represents similarly situated, terminally ill patients who only want one last shot at life. Eschenbach is commissioner of the FDA.

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