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House to Try Again on Bill Easing Use of Unapproved Drugs

By Alan Farm, AP | March 16, 2018

The House plans to try anew next week to approve a Republican bill making it simpler for fatally ill people to try unproven treatments. And this time, the measure seems certain to pass.

Lawmakers voted for the legislation on Tuesday by a lopsided 259-140 vote. But it lost because GOP leaders had used a procedure, normally reserved for uncontroversial bills, that requires a two-thirds majority for passage. Tuesday’s vote fell just short of that.

President Donald Trump backed the legislation and GOP lawmakers lined up behind it nearly unanimously, but Democrats opposed it by more than a 4-1 margin.

Under the measure, the Food and Drug Administration would no longer have to sign off if a doctor and a drug manufacturer agree to let a patient try a pharmaceutical that’s not been approved by the federal agency.

Republicans say the measure would provide hope for patients desperate for any chance of survival.

Democrats say the bill isn’t needed because the FDA already approves 99 percent of such requests under an existing program. They also say it leaves unaddressed the chief reason why such patients don’t get experimental drugs — manufacturers often decline to provide them because they don’t have enough of the item or worry that prospects for profiting from it would be damaged if a problem occurs.

The Senate approved similar legislation last August. Congress would have to approve compromise legislation before it can be sent to Trump for his signature.

The House Rules Committee said Thursday that it would clear the way Monday for the full chamber to debate a bill with the same name as the measure that failed. Zachary Hunter, spokesman for Republicans who control the House Energy and Commerce Committee, said the bill would be identical to the rejected legislation. This time the bill would only require a simple majority to be passed.


Filed Under: Drug Discovery

 

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