FDA broadens access to experimental drugs

The FDA has moved to widen access to experimental drugs, allowing drug developers to provide therapies to terminally ill patients and charge for the treatment. The subject has long been a sore point with advocacy groups and patients anxious to get their hands on therapies that are unproven but could extend their lives. The new rules give seriously ill patients a better shot at obtaining those drugs, and it can provide some revenue for biotechs pushing drugs through the pipeline. The agency has been fighting a lawsuit brought by the Washington Legal Foundation on behalf of the Abigail Alliance for Better Access to Developmental Drugs which essentially wants the FDA to step aside and let certain patients buy these drugs during development. The FDA has resisted that effort, though, saying that it has a responsibility to continue to regulate the field. Meanwhile, Public Citizen is criticizing the move, saying that providing unproven drugs to patients could do more harm than good [1].

- here's the Chicago Tribune article [2] on the FDA's move

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FDA may boost experimental drug access. Report [4]
FDA approves surging number of NDAs. Report [5]
FDA offers accelerated review for select generics. Report [6]