FDA Floats Plan to Widen Access to Trial Drugs

The Food and Drug Administration proposes making experimental drugs more widely available to patients with serious illnesses such as cancer and AIDS. But the drugs, which lack FDA approval, may carry serious risks.

The FDA proposal would allow drug companies to charge for the drugs, which are in the very early stages of testing — the first of three phases. There is no guarantee of their safety.

But even for gravely ill patients who have exausted all the standard treatments, gaining access to experimental drugs means navigating a lot of red tape.

A 90-day public comment period on the proposed policy began Monday.

Michele Norris talks with Dr. Jerome Groopman, author of The Right to a Trial: Should Dying Patients Have Access to Experimental Drugs? in the Dec. 18 issue of The New Yorker.

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