May 31, 2018
Nearly 90% of Americans want the chance to try experimental drugs when they are critically ill and “have everything to gain and nothing to lose,” based on findings of a poll conducted in March by CancerHealth.com.
They (and their families and friends) are celebrating the passage of Right to Try legislation by the U.S. House of Representatives—successfully culminating a multi-year campaign by the Goldwater Institute to give such patients access to drugs not yet approved by the Food and Drug Administration (FDA). Specifically, the bill gives terminally ill patients the right to seek drug treatments that remain in clinical trials and “have passed Phase 1 of the Food and Drug Administration’s approval process,” but have not been fully approved by the agency.
The House passed the bill, sponsored by Senator Ron Johnson (R-Wisconsin), on May 29 by a vote of 250 to 169, sending it on to President Donald Trump’s desk for signature. According to coverage by Biopharma Dive, the act covers a much broader population than an earlier House-passed version. The president has been a vocal advocate despite warnings from patient groups and top FDA staffers including Commissioner Scott Gottlieb that it may have unintended effects and potentially hinder FDA’s authority .
On the other hand, Biopharma Dive reported, conservative groups—including Freedom Partners and Americans for Prosperity—backed the effort; calling attention to the fact that 40 states have passed versions of the bill.
“The Administration believes that these patients and their families should be able to seek access to potentially life-saving therapies while those treatments are still under review by the FDA,” an administration policy statement said.
The legislation passed via unanimous consent in the Senate last August.
In a May 21 letter, more than 100 patient advocacy groups—among them, The American Cancer Society, the Alliance of Dedicated Cancer Centers, the Cancer Action Network, Friends of Cancer Research and the National Organization for Rare Disorders—urged House Speaker Paul Ryan (R-Wisconsin) and Minority Leader Nancy Pelosi (D-California) to reject the bill. The groups argued that. while they did not support the previous House-passed bill either, at least it had comprised several safeguards that are missing from the new legislation.
Senior House GOP leadership praised the bill as a leap forward for patients.
Research contact: @SGottliebFDA