By clarifying standards governing patient rules to "investigations" drugs, FDA leaders said the hope to help more people receive benefits from medicines that haven't yet been approved.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research within the FDA, said that the drugs would be available only to patients who are gravely ill or have life-threatening conditions, and for whom no other reasonable treatment alternatives exist. Right now it's not clear how many more patients would benefit from the new protocols, she notes.
The FDA has had a formal process in place to help seriously ill patients get access to investigative drugs since 1987, and an informal one since the 1970s, but the new rules should make things easier to get these drugs.
This should be great news for groups like the Abigail Alliance, which have been fighting for years to expand access to experimental drugs for dying patients.
To learn more about the FDA's new policy:
- read this HealthDayNews piece
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