House passes controversial ‘right to try’ legislation for terminally ill patients

WASHINGTON — The House on Wednesday passed legislation aimed at giving seriously ill patients increased access to investigational drugs, a bill championed by Vice President Mike Pence in part because of an Indianapolis 8-year-old with Duchenne muscular dystrophy.

The House voted 267 to 149 for the “right to try” bill, named partly for Jordan McLinn whose frequent trips to Washington to advocate for the bill have inspired him to want to be president one day.

“This bill allows Jordan to have those big dreams,” said Rep. Susan Brooks, R-Ind. “And it will be providing patients across this country with big dreams.”.

But opponents said the bill undermines the Food and Drug Administration’s existing compassionate use program while giving false hope to dying patients.

“If this is such a patient-centered bill, then why does every major patient-centered group oppose it?” Asked Rep. Frank Pallone, D-N.J.

Patient groups also oppose a slightly different of the legislation, co-authored by Indiana Sen. Joe Donnelly, that unanimously passed the Senate last year.

“I look forward to getting this across the finish line as soon as possible,” Donnelly said in a statement.

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But it’s unclear if lawmakers will resolve the differences and pass a final version of the bill this year.

The House bill would let patients who are near death, or who have a disease that is likely to lead to severely premature death, potentially access drugs that have gone through only preliminary testing on humans. They would have to be ineligible for a clinical trial and have already tried other available treatments.

“If I were faced with one of these heart-rendering situations, I would take any risk, including injecting monkey urine,” said Rep. Morgan Griffith, R-Va., “If that meant I could spend a few more days, months or years with my children.”.

Patients can already apply to the FDA’s expanded drug access program.

Of the nearly 5,800 requests the FDA received from 2012 through 2015, the agency approved 99 percent of them, according to the Government Accountability Office. The most common reasons requests were denied included incomplete applications, safety concerns, the availability of adequate alternative therapies and evidence that the drug was ineffective for the intended use, according to the GAO.

The Goldwater Institute, a conservative think tank based in Phoenix that has pushed for “right to try” legislation at the state and federal level, discounts that statistic.

Starlee Coleman, Goldwater Institute senior policy adviser, said doctors only apply to the program if they’ve gotten an informal indication from the FDA that their patient would qualify.

The House bill would let a patient bypass the FDA’s program.

Patient advocacy groups, including the American Cancer Society Action Network and the American Lung Association, argue the FDA can make important dosing and other safety improvements to the administration of the medication.

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FDA Commissioner Scott Gottlieb has said the biggest obstacle to patients getting experimental medication is drug availability.

Drugmakers may have only a limited quantity of the drug, may not have enough resources to administer expanded access requests, or may worry that offering the drug would make it harder to recruit participants for the clinical trials necessary to get FDA approval of the product.

Advocates argue drugmakers aren’t participating because they need the liability protection the bill would offer.

Democrats unsuccessfully tried to amend the legislation to provide the liability protection without allowing patients to go outside the existing FDA expanded used program.

That failed 182 to 233.

President Trump has urged lawmakers to pass legislation and Pence was involved in the crafting of the House bill.

Jordan McLinn was at Pence’s side when, as governor, Pence signed Indiana’s version of the legislation into law in 2015. He told the McLinn family he was committed to the cause and offered to help any way he could.

At the time, Jordan did not qualify for a clinical trial. He has since been enrolled in a trial for a drug that could slow the progression of his disease.

So the bill, if it becomes law, would offer no immediate benefit to Jordan. But he could be helped in the future if drugs to cure his form of muscular dystrophy make it through an initial round of human testing, according to his mother.

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“Why do you not want to allow these patients their right to fight for their future?” Said Rep. Michael Burgess, R-TX.

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