Former FDA heads speak out against ‘right to try’

Four former heads of the Food and Drug Administration (FDA) are urging Congress to abandon bills that would allow terminally ill patients access to experimental drugs not yet approved by the agency. 

The “right to try” bill failed in the House last week, but is likely to come up again this week. A similar bill passed the Senate last summer.

Former Obama FDA commissioners Robert Califf and Margaret Hamburg, and former George W. Bush commissioners Mark McClellan and Andrew von Eschenbach said in a statement the bills would “erode protections for vulnerable patients.” 

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“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,” the commissioners wrote, according to The Washington Post.

The bill failed in the House by a vote of 259-140 last week, largely because of opposition from Democrats.

The bill would let terminally ill patients request access to drugs the FDA hasn’t yet approved — and do so without going through the agency. Patients would have to be ineligible for clinical trials and have tried all other available treatments.

Democrats and patient advocacy groups argue the bill could be harmful to patient safety.

“FDA is part of the process for a reason: it protects patients from potentially bad actors or from experimental treatments that might do more harm than good,” Rep. Frank Pallone Jr. (D-N.J.), the top Democrat on the House Energy and Commerce Committee, said in a statement last week. 

Passing the bill has been a priority for Republicans in Congress and it is strongly supported by President Trump and Vice President Pence.