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A Right To Try Arrives

A Right To Try Arrives

Senator Ron Johnson in Washington, D.C., May 15.

Senator Ron Johnson in Washington, D.C., May 15.


Photo:

erin schaff/Reuters

The House on Tuesday passed a bill that would allow some patients to seek medical treatments still in clinical trials, and this is a welcome end to some messy sausage-making. But it isn’t a GOP license to forget about the more fundamental bureaucratic obstacles to drug approvals.

The House passed 250-169 a bill sponsored by Senator Ron

Johnson

of Wisconsin that passed the Senate by unanimous consent last year. The bill is named for patients such as Wisconsin mother of three

Trickett Wendler,

who died in 2015 after a battle with ALS. Another is

Jordan McLinn,

a young boy in Indiana who has

Duchenne

muscular dystrophy.

The House over several months made changes to the Senate bill and then passed its own version this spring from House Energy and Commerce Chairman

Greg Walden.

Mr. Johnson then tried to move the House bill in the Senate, but Minority Leader

Chuck Schumer

blocked it for unexplained reasons.

Foreign Edition Podcast

The question since has been if the bill would die. Mr. Walden deserves credit for finally accepting the Johnson version instead of insisting on his own bill that would fail. The delta between the two versions involved in part who could “try” drugs—did a patient’s diagnosis have to be terminal?—but the differences aren’t worth derailing the project.

The core of the bill is to allow drug manufacturers and patients to enter into mutual agreements without government approval. Many drug companies will decline to provide experimental treatments because they fear this could distract from the goal of FDA approval. But right to try is still important as a message from Congress that patient and physician prerogative are more important than bureaucratic whim.

President

Trump

is eager to sign the bill, and he kicked off a speech on drug prices this month with some spontaneous lingua franca to FDA Commissioner

Scott Gottlieb

: “Where is

Scott

? Stand up, Scott. Stand up. And ‘right to try’ is happening, right? You have that moving? ‘Right to try.’ So important.” Vice President

Mike Pence

has long been an advocate.

Right to try has moved because Americans perceive that new drugs aren’t reaching patients quickly enough, and they’re right. Discovering a new drug is perhaps the riskiest bet in all of American business. Three phases of clinical trials can last more than six years, and the third part involves as many as 3,000 patients. This model is untenable as discoveries target ever smaller patient populations in the emerging era of biomedicine.

Dr. Gottlieb

has been updating FDA processes, but the movement could use more political firepower from Congress. Let’s hope the right-to-try moment is the first of many to help patients receive potentially life-saving treatments as soon as possible.

Published at Tue, 22 May 2018 22:59:26 +0000