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The Washington Examiner – House votes to give terminally ill patients the 'right to try' experimental drugs

The Washington Examiner – House votes to give terminally ill patients the 'right to try' experimental drugs

The House passed legislation on Tuesday that would give terminally ill patients the right to try experimental treatments, sending a major White House priority to President Trump’s desk after several false starts.


The bill, which passed 250-169 and has been a priority for conservative think tanks and outside groups, now goes to Trump, who has indicated he will sign it. Trump famously made a push for the bill, known colloquially as “right to try,” during his first State of the Union address in January.


The bill is identical to a version that passed the Senate in August and sponsored by Sens. Ron Johnson, R-Wis., and Joe Donnelly, D-Ind.


The legislation would create a new pathway for terminally ill patients to try an experimental treatment. A terminally ill patient could apply to gain access to a drug that has gone through the first of three clinical trials required for FDA approval.


The bill would allow patients to circumvent the FDA’s compassionate use program, which lets a patient get access to an experimental drug. However, the bill does not require the drugmaker to provide the drug, a key obstacle under the compassionate use program.


“Great news. The House just passed a bill providing terminally ill patients with access to experimental treatments and therapies for the chance at a longer life. These patients — and their loved ones — deserve the right to try,” House Speaker Paul Ryan wrote on Twitter after the vote.


The bill’s advocates hope new provisions will give drugmakers an incentive to provide the treatment. Drugmakers typically don’t like to provide access to an experimental drug outside of a clinical trial.


The problem is if the patient dies, that could affect approval from the FDA, even though patients who would get the drug through “right to try” would be likely sicker than patients in a clinical trial.


The bill aims to give certainty to manufacturers to the FDA on how the agency will use the patient outcomes in product approvals.


Democrats and some patient advocacy groups are opposed to the measure. They say it will expose terminally ill patients to unsafe and ineffective products.


“This bill is harmful legislation that offers a false hope,” said Rep. Cathy Kastor, D-Fla. “The bill establishes a dangerous and unnecessary alternative pathway that is void of any FDA oversight.”


She added that the FDA approves 99 percent of the requests under compassionate use.


A group of more than 100 patient groups, including the National Organization for Rare Disorders and Friends of Cancer Research, wrote to House members on Tuesday asking for the bill to be voted down.


The vote culminates a winding journey for a policy idea that has been trumpeted by conservatives and was passed among 38 states. Vice President Mike Pence signed a state right-to-try law when he was Indiana’s governor.


The state laws, however, are rendered inert because they cannot circumvent federal law.


The Goldwater Institute, a conservative think tank, has touted the legislation, as have outside conservative groups backed by Republican mega-donors Charles and David Koch.


The bill that the House passed was approved by the Senate in August 2017 as part of a larger package to reauthorize a user fee agreement for the Food and Drug Administration.


President Trump also gave a resounding endorsement during his State of the Union and Pence has been pushing for the legislation behind the scenes.


Trump even made a quick nod to “right to try” during his May 11 Rose Garden speech on drug prices, asking when the bill will get through the House.


But the bill languished in the House Energy and Commerce Committee since its Senate passage. Chairman Greg Walden, R-Ore., had said he was working on a compromise version.


The House version had a more narrow definition of who would be able to use the program. It passed along party lines in March.


Johnson tried to get it brought up in the Senate by unanimous consent, an avenue to quickly pass uncontroversial legislation. However, Senate Minority Leader Chuck Schumer objected to the move, and the bill has gone nowhere in the Senate since then.


Senators also tried to create a new compromise version, but that effort collapsed this week.


Johnson told reporters Wednesday that he was not involved in the talks and that he and Donnelly did not support the talks.


“I think both Sen. Donnelly and myself issued a statement yesterday to say that was not possible or feasible,” he said.…