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FDA Wants Easier Access to Experimental Drugs

Rule change will clarify when they can be offered and at what cost

WEDNESDAY, Dec. 13 (HealthDay News) -- The U.S. Food and Drug Administration is planning to overhaul regulations governing the availability and cost of experimental drugs in order to make it easier for seriously ill patients with no other treatment options to get access to them. The proposed changes will be open for public comment for 90 days.

Individual patients, small groups and larger populations would have access to experimental drugs under the proposed new rule in circumstances where there is no satisfactory alternative available.

The current rules only specifically mention emergency use for individuals and widespread use for large groups. However, there are a range of programs under which experimental drugs can be used. In addition, rules on charging for such drugs have also proven difficult to interpret in practice and also need clarification, the FDA states.

"FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients," said Janet Woodcock, M.D., FDA's Deputy Commissioner for Operations, in a statement. "By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for health care practitioners in obtaining them."

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