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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 TrumpTrump alludes to possible 2024 run in White House remarks Trump threatens to veto defense bill over tech liability shield Tiger King's attorney believes they're close to getting pardon from Trump 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 JohnsonGrassley returns to Capitol after having coronavirus McConnell halts in-person Republican lunches amid COVID-19 surge Loeffler isolating after possible COVID-19 infection 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 PalloneHouse Democrats urge Amazon to investigate, recall 'defective' products Asbestos ban stalls in Congress amid partisan fight Pharma execs say FDA will not lower standards for coronavirus vaccine 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: Leadership changes at top cyber agency raise national security concerns | Snapchat launches in-app video platform 'Spotlight' | Uber, Lyft awarded federal transportation contract Lawmakers urge FCC to assist in effort to rip out, replace suspect network equipment OVERNIGHT ENERGY: Barrasso to seek top spot on Energy and Natural Resources Committee | Forest Service finalizes rule weakening environmental review of its projects | Biden to enlist Agriculture, Transportation agencies in climate fight MORE (R-Ore.) and health subcommittee Chairman Rep. Michael BurgessMichael Clifton BurgessLawmakers push for improved diabetes care through tech advancements Overnight Health Care: Schumer, Pelosi want Heroes Act as 'starting point' in new COVID-19 relief talks | Labs warn of possible delays in test results amid surge in demand | Federal government partners with pharmacies for coronavirus vaccine distribution Overnight Health Care: COVID-19 cases rising in every state | Wisconsin health official warns state nearing 'tipping point' | Fauci predicts data from Moderna vaccine within a week 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 GriffithGOP Rep. Dan Newhouse tests positive for COVID-19 Colorado Democrat Ed Perlmutter tests positive for coronavirus Bustos tests positive for COVID-19 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.