Former FDA heads speak out against 'right to try'

Former FDA heads speak out against 'right to try'
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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." 


“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.Frank Joseph PalloneOvernight Health Care — Presented by That's Medicaid — Deal on surprise medical bills faces obstacles | House GOP unveils rival drug pricing measure ahead of Pelosi vote | Justices to hear case over billions in ObamaCare payments Obstacles remain for deal on surprise medical bills This week: House impeachment inquiry hits crucial stretch MORE (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 TrumpDonald John TrumpWarren: Dershowitz presentation 'nonsensical,' 'could not follow it' Bolton told Barr he was concerned Trump did favors for autocrats: report Dershowitz: Bolton allegations would not constitute impeachable offense MORE and Vice President Pence.