Four former commissioners of the Food and Drug Administration are expressing opposition to congressional “right to try” legislation, just as Republican House leaders prepare to bring a bill up for another vote a week after it failed to pass.
The legislation is designed to allow seriously ill patients to bypass the FDA to get access to experimental treatments. The former agency commissioners, in a joint statement provided to The Washington Post, criticize both House and Senate proposals.
“There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients,” they say.
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GOP lawmakers say right-to-try bills…would give desperately ill patients a last chance at survival. Democrats say the measures would skirt FDA rules designed to protect patients without addressing basic obstacles to accessing experimental medications…
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Critics also note that the FDA already has an expanded-access program for approving experimental drugs for patients who are not in clinical trials…
The House and Senate bills are designed to give patients access to medications that have undergone only preliminary testing in humans. Patients would have to be ineligible for clinical trials and first try all other available treatments.
Read full, original post: Former FDA commissioners say right-to-try bills could endanger ‘vulnerable patients’
