House passes 'right to try' drug bill

House passes 'right to try' drug bill
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The House passed “right to try” legislation on experimental drugs largely along party lines Wednesday, sending a bill backed by President TrumpDonald John TrumpCensus Bureau spends millions on ad campaign to mitigate fears on excluded citizenship question Bloomberg campaign: Primary is two-way race with Sanders Democratic senator meets with Iranian foreign minister MORE to the Senate.

Last week, House Republican leaders put the bill on the floor under suspension of the rules. Democrats objected, expressing safety concerns over how the measure would bypass the Food and Drug Administration (FDA), and it fell short of the necessary two-thirds support it needed.

But leaders made clear the House would take up the bill again. On the second try, the House only needed a simple majority to pass the bill, and easily did so in the 267-149 vote.

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Thirty-five Democrats voted for the bill, and two Republicans opposed it. 

Now, the measure goes to the Senate, where a version of the bill passed in August by unanimous consent.

Sen. Ron JohnsonRonald (Ron) Harold JohnsonCongress looks to strengthen hand in State Department following impeachment Senate braces for fight over impeachment whistleblower testimony Father of Parkland shooting victim calls on Congress to take action MORE (R-Wis.), who has championed the bill in the Senate, urged his chamber to quickly pass the measure. 

“Right to try needs to become the law of the land. It passed the Senate unanimously last summer, and I’m disappointed the House didn’t pass that bill and send it to the president for his signature," Johnson said in a statement.

"Nonetheless, I plan to ask my colleagues to pass right to try again immediately. Terminally ill patients and their families have waited long enough.”

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House Republicans revised the bill amid objections from some supporters who had hoped the Senate version would pass, wanting to prevent the measure from ping-ponging between the two chambers. They worried that could make it harder to get the bill to Trump’s desk.

The bill lets terminally ill patients request access to drugs the FDA hasn’t yet approved without going through the agency. Patients can request the drugs from manufacturers if the medicine has gone through a small-scale clinical trial and is still under FDA consideration.

Though no senators objected to the bill, the legislation — which had been revised — proved controversial in the House.

Democrats there, as well as more than 75 patient advocacy groups, have voiced several different concerns, and patient safety was chief among them.

“By allowing patients access to investigational treatments that have only completed a phase 1 clinical trial, patients will be exposed to treatments with no or relatively little data that they are actually effective,” the top Democrat on the House Energy and Commerce Committee, Rep. Frank Pallone Jr.Frank Joseph PalloneOvernight Health Care — Presented by That's Medicaid — Deal on surprise medical bills faces obstacles | House GOP unveils rival drug pricing measure ahead of Pelosi vote | Justices to hear case over billions in ObamaCare payments Obstacles remain for deal on surprise medical bills This week: House impeachment inquiry hits crucial stretch MORE (N.J.), said during the debate on the House floor Wednesday.

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“These extremely small trials only examine the safety and toxicity of a drug and do not determine the effectiveness or potential side effects.”

Opponents of the bill also point to the FDA’s compassionate use program, saying the agency approves 99 percent of requests to let a patient use an experimental drug. They argue the legislation provides “false hope,” as drug manufacturers aren’t required to provide the drug to patients who ask.

But House Energy and Commerce Chairman Greg WaldenGregory (Greg) Paul WaldenGOP climate plan faces pushback — from Republicans Coalition plan seeks to cut carbon emissions in half by 2035 Overnight Energy: Panel gives chairman power to subpoena Interior | House passes bill to protect wilderness | House Republicans propose carbon capture bill | Ocasio-Cortez introduces bill to ban fracking MORE (R-Ore.) and health subcommittee Chairman Rep. Michael BurgessMichael Clifton BurgessOvernight Health Care — Presented by Partnership for America's Health Care Future — Juul pitched products to Native American tribes | Vaping execs deny deliberately targeting young people | Republicans seek hearing on Medicaid block grants Overnight Health Care: Big Pharma looks to stem losses after trade deal defeat | House panel to examine federal marijuana policies | House GOP reopens investigation into opioid manufacturers Lawmakers express alarm over rise in cocaine overdose deaths MORE (R-Texas) maintained that their version of the bill struck “the right balance for patients and their safety.”

Supporters of the measure have argued that people with a terminal illness should have every tool at their disposal to try a drug that could possibly help them.

Rep. Morgan GriffithHoward (Morgan) Morgan GriffithAbortion wars flare up in Congress Overnight Health Care: Big Pharma looks to stem losses after trade deal defeat | House panel to examine federal marijuana policies | House GOP reopens investigation into opioid manufacturers House GOP reopens investigation into opioid manufacturers over role in crisis MORE (R-Va.) said if faced with a terminal illness, he’d “take any risk, including injecting monkey urine, if that meant I could spend a few more days, months or years with my children.”

Proponents of the legislation have also argued that the drug approval process takes too long, and that the bill isn't unsafe, as medicines must have passed a phase 1 clinical trial and still be in FDA’s pipeline.

The legislation has powerful backers.

President Trump has urged Congress to pass the bill, notably in his State of the Union address in late January. Vice President Pence is a staunch supporter of right to try, signing a version of the bill into law when he was governor of Indiana. And groups backed by conservative mega-donors Charles and David Koch have also been pushing for its passage.