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Senate HELP Scraps House Approach on Medical Innovation

By Andrew Siddons, CQ Roll Call

January 20, 2016 -- Instead of following the House's lead and advancing a comprehensive bill designed to spur medical innovation, the Senate Health, Education, Labor, and Pensions (HELP) Committee will consider a set of narrower bills with the same goal in mind, the panel's chairman said on Tuesday.

Following last summer's House passage of the so-called 21st Century Cures Initiative (HR 6), Sen. Lamar Alexander, R-Tenn., maintained that his goal was to have a Senate companion measure marked up by the end of 2015.

On Tuesday, it became clear that the committee was unable to come to a bipartisan agreement on a comprehensive package.

Instead, the committee will hold three markups in the coming months to consider targeted legislation that would tweak the Food and Drug Administration's (FDA) approval processes for drugs and medical devices and strengthen the research muscle of the National Institutes of Health (NIH).

"Senators and staff on our committee have been working together throughout 2015 to produce a number of bipartisan pieces of legislation that are ready for the full committee to consider," Alexander said.

The HELP panel's top Democrat, Patty Murray of Washington, said she was pleased the committee will hold the markups. But a Democratic aide said there is no agreement on the path forward beyond the first markup, and Murray's statement hinted at the areas where the parties couldn't see eye to eye.

"I've made clear I believe this progress should include addressing the burden that high drug costs impose on patients, as well as critical mandatory investments in research and development at NIH and the FDA," Murray said.

The first markup will be held on Feb. 9, during which lawmakers will take up at least seven bipartisan bills.

A draft of one of the measures that would address electronic medical records will be released later this week, Alexander said. The bill would aim to decrease unnecessary documentation and increase access to health records by medical professionals and patients.

The other bills under consideration include one (S 2030) that would make it easier for companies working on treatments for rare diseases to win FDA approval, a measure (S 1622) that would seek less burdensome FDA reviews of medical devices and a bill (S 2014) that aims to enhance the abilities of younger researchers at the NIH.

A second markup to be held March 9 will focus on legislation that Alexander said would support President Barack Obama's precision medicine initiative. A third markup will be held April 6.

Even though the Senate is taking a different path than the House did, the members behind 21st Century Cures, Reps. Fred Upton, R-Mich., and Diana DeGette, D-Co., appeared to view Alexander's announcement as good news.

"The Senate announcement is just the latest positive milestone in the effort to give patients and their loved ones more hope," the lawmakers said in a joint statement. "But we have much work left to do to make 21st Century Cures a reality. The vice president is working on a 'moon shot' to cure cancer, and we've got a rocket ship ready to go."

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