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 TrumpComey: Trump's 'Spygate' claims are made up Trump taps vocal anti-illegal immigration advocate for State Dept's top refugee job Seattle Seahawks player: Trump is 'an idiot' for saying protesting NFL players 'shouldn’t be in the country' 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.

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 JohnsonHouse GOP sets three FBI interviews in Clinton probe Overnight Health Care — Sponsored by PCMA — House passes 'right to try' drug bill | Trump moves to restrict abortion referrals House approves 'right to try,' sends bill to Trump's desk 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.”

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 PalloneHillicon Valley: Experts worry North Korea will retaliate with hacks over summit | FBI works to disrupt Russian botnet | Trump officials look to quell anger over ZTE | Obama makes case for tighter regs on tech Dem calls for hearing on alleged wireless data disclosures House approves 'right to try,' sends bill to Trump's desk MORE (N.J.), said during the debate on the House floor Wednesday.

“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 WaldenHillicon Valley: Experts worry North Korea will retaliate with hacks over summit | FBI works to disrupt Russian botnet | Trump officials look to quell anger over ZTE | Obama makes case for tighter regs on tech Dem calls for hearing on alleged wireless data disclosures 'Right to try' is an ill-considered bill MORE (R-Ore.) and health subcommittee Chairman Rep. Michael BurgessMichael Clifton BurgessHouse approves 'right to try,' sends bill to Trump's desk Overnight Health Care: New allegations against VA nominee | Dems worry House moving too fast on opioid bills | HHS chief back in DC | FDA reexamines safety of controversial Parkinson's drug Top Dems on Energy and Commerce panel concerned House opioid push moving too quickly 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 GriffithFood stamp revamp sparks GOP fight over farm bill Lawmakers explore ways to reinstate House chaplain 25 House Republicans defy leadership in key spending bill vote 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.