Partisan split threatens progress on bill to speed drug approvals
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WASHINGTON — When Republican senators overseeing legislation to accelerate medical treatments said last month they would chop the bill into parts — rather than passing comprehensive legislation — their Democratic counterparts put on a good face.

“We’re looking forward to working together in a bipartisan fashion to finish the legislation,” said Senator Patty Murray of Washington, ranking Democrat on the Committee on Health, Education, Labor and Pensions.

Behind the scenes, though, aides say the Democrats were blindsided by the move, and warn that the Republican decision threatens to undermine bipartisan support for one of the most significant pieces of legislation on medical research in years.

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The decision to consider the legislation, dubbed 21st Century Cures, step by step is, on the one hand, a formality when it comes to the sometimes opaque process of lawmaking. But Democrats are also worried that the procedural shift is a way for Republicans to leave out the provisions that they have been championing, particularly a long-term boost in funding for the National Institutes of Health.

The Republicans’ main interest in the 21st Century Cures bill is streamlining certain Food and Drug Administration requirements for getting new drugs and medical devices on the market. Democrats have said they will not support the legislation without additional funding for the NIH and the FDA.

“If you want the FDA to be able to approve drugs more quickly, without rolling back the gold standard of consumer safety and protection, then the FDA is going to need more support to do its job,” Murray said at a hearing last week. “I believe as part of our committee’s effort to advance medical innovation for families, it is critical that we increase mandatory funding for the FDA and NIH.”

The House has already passed its version of the 21st Century Cures bill, and the chairman of the Senate HELP committee, Senator Lamar Alexander (R-Tenn.), has said that he hopes his chamber will move forward with its own legislation. He has said that by breaking the legislation into parts, the committee can agree on the least controversial aspects first and continue to move forward.

“It is urgent that the Senate finish its work and turn into law these ideas that will help virtually every American,” Alexander said in a statement.

A spokesman for Alexander said Democrats on the committee had several days to review his new plan, and suggested that they had a communications glitch.

The White House is counting on congressional action for its own priorities. President Barack Obama’s Precision Medicine Initiative and Vice President Joe Biden’s cancer “moonshot” both will rely, in large part, on federal funding.

The House bill, passed in July, provided an increase of nearly $9 billion from current funding levels for the NIH over five years, and a much smaller increase for the FDA. In December, the Senate approved a budget that gave an additional $2 billion for NIH, but Democrats say that is not enough to accomplish the agency’s goals, given the renewed focus on accelerating cures.

Now, Democratic aides say the Republican decision to consider the 21st Century Cures bill in piecemeal fashion will make it harder for the HELP committee, which traditionally moves in bipartisan fashion, to pass legislation at all.

“I think they are not going to be able to do anything, except perhaps pass a couple of feel-good bills,” said one aide, speaking on condition of anonymity because he was not authorized to speak on the record.

Diana Zuckerman, president of the National Center for Health Research, said “cutting a comprehensive bill into single-issue nuggets doesn’t solve the problem.”

“Bipartisan support,” she said, “is still needed.”

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