House to vote Tuesday on ‘right to try’ drug bill

The House will vote Tuesday on a newly released Right to Try Act aimed at letting very sick patients request access to treatments the Food and Drug Administration (FDA) hasn’t yet approved.

The legislation is a priority for the White House.

President Trump called on Congress to pass the legislation in his State of the Union address in January. Vice President Pence is also a staunch supporter of right to try laws, signing a bill when he was governor of Indiana.

House Energy and Commerce Committee leaders had been working to change the bill, which passed the Senate by unanimous consent over the summer.

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Supporters of the measure, such as groups backed by conservative mega-donors Charles and David Koch, had been urging the House to pass the Senate version, fearing changes could make it harder for the bill to get to Trump’s desk.

The new version will indeed have to be sent back to the Senate, and in announcing the Tuesday vote, House Majority Leader Kevin McCarthy (R-Calif.) noted in a statement Sunday that “following its passage, I look forward to swift Senate action so more Americans facing dire circumstances can find some light in their darkest moments.”

Over the last few months, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) had been clear that changes to the legislation — a revised bill which was unveiled in a press release early Saturday morning — were coming.

“As you know, some of the advocacy groups have actually been concerned about the language that came over from the Senate and are not full throated in support of it, and so we want to make sure that we listen to them, and that we get this in a way that works for everybody,” Walden told reporters in early February.

Nearly 40 patient advocacy groups had argued that the measure would “likely do more harm than good” in a letter in early February. They said the Food and Drug Administration’s current regulatory framework is meant to protect patients, and that the FDA has a program that approves nearly all requests of patients to try an experimental drug.

Proponents of the measure had countered that terminally ill patients should have every tool at their disposal to try a drug to potentially help them, and that the decision to do so should be between a doctor and a patient, not the patient and the government.

The House version of the legislation appears to further define which patients can request access to an experimental drug. To be eligible, a patient must have a disease or a condition with a “reasonable likelihood that death will occur within a matter of months” or would result in “significant irreversible morbidity that is likely to lead to severely premature death.”

The former is the language FDA Commissioner Scott Gottlieb recommended in October testimony before the House Energy and Commerce Subcommittee on Health.

A GOP committee spokesperson wrote in an email that the House draft also “improves patients protections” on informed consent and reporting on adverse events. It requires notifying the FDA when a patient receives an experimental drug through the right to try path. 

In a statement Sunday, Walden and the panel’s health subcommittee chairman, Rep. Michael Burgess (R-Texas), said “the bill has been a long-time coming, but in striking the right balance for patients and their safety, the House is on track to deliver hopeful news for patients desperately seeking the right to try investigational treatments and therapies.”

Patients can ask for access to the investigational drugs, but drugmakers are not required to give out the medicines.

Freedom Partners, a Koch-backed group, urged Congress to pass the House bill.

In a statement Sunday Freedom Partners executive vice president Nathan Nascimento urged lawmakers to “take a critical step towards giving every American the right to try. With no time to waste, we encourage every member to support this measure.”

Rep. Frank Pallone (D-N.J.), the top Democrat on the House Energy and Commerce Committee, is opposed to the bill released Saturday, according to a Democratic Committee spokesman.

Updated: 5:51 p.m.