The Senate's breakthrough medical cures bill will be so bipartisan that it can get passed even in the 2016 election year, the top Republican working on the legislation said Monday.
"With the kind of support it has now, and that I expect it to have at the end of the year, I fully expect it to be the kind of legislation that could be considered by Congress even in an election year," said Sen. Lamar Alexander, R-Tenn. "Which is something to be proud of."
Scientists, doctors and policymakers have long been concerned about the speed at which new drugs are developed in the U.S. Just one new drug is approved per billion dollars spent on research and development, compared with nearly 100 drugs per billion dollars spent back in the 1950s.
Earlier this month, the House passed amid much bipartisan applause legislation aimed at speeding up how breakthrough drugs and treatments are discovered, approved and brought to the market. Now the Senate is working on its own bill, led by Alexander and Sen. Patty Murray, his Democratic counterpart on the Health, Education, Labor and Pensions Committee.
It probably will be near the end of the year before the HELP committee approves any legislation, Alexander said. In the meantime, he is accepting suggestions for how to construct the legislation, including a set of suggestions from the Bipartisan Policy Center.
A paper the group released Monday says the Senate version should go further than the House bill by requiring the Food and Drug Administration to make late-stage clinical trials more collaborative, help patients learn about safe, off-label uses of drugs and take steps to improve the use of health information technology.
The group, which was founded by former Democratic majority leaders Tom Daschle and George Mitchell and former Republican majority leaders Howard Baker and Bob Dole, also recommended that the FDA clarify how it approves and regulates laboratory-developed tests, those that are designed, manufactured and used within a single laboratory, which are important in the use of personalized medicine.
Alexander said he will consider the recommendations carefully, speaking at a gathering hosted by the policy center. But whatever reforms end up in the final legislation, he said a major goal is to ensure it has strong, bipartisan support, which few bills achieve in Congress these days.
He hopes it will be supported by members ranging from liberal Sen. Elizabeth Warren to libertarian Sen. Rand Paul. "We have, let's just say, a diverse committee," Alexander said. "We're all interested in this and we all want to do the right thing."
Alexander's committee is also holding a series of hearings on health information technology, which includes the electronic medical records that doctors have had such trouble incorporating into their daily use. Alexander said he has been talking to Health and Human Services Secretary Sylvia Burwell about improvements in that area, possibly through executive order if it is possible.
"If we can come up with five or six things she can do by executive order, so much the better," Alexander said, although he added that he will introduce legislation if necessary.