When it comes to his 21st Century Cures initiative, House Energy and Commerce Committee Chairman Fred Upton has an aggressive timeline in mind, starting with a subcommittee markup Thursday and ending with a bill on the desk of the president by the end of the year.
The Senate, being the Senate, isn’t moving as quickly.
The legislation, in general, aims to enhance biomedical innovation by addressing how medical research is conducted and accelerating the process. It’s an issue that President Obama singled out in his State of the Union address and has key lawmakers on all sides of Capitol Hill engaged. That doesn’t mean everything will go smoothly.
“There are not many things on Capitol Hill today about which there’s as much enthusiasm as our innovation project, and that’s why we’re taking the time during 2015 to get it right, and then we’ll take our best ideas and put them together with the House of Representatives in a bill to the president,” said Sen. Lamar Alexander, chairman of the Senate Health, Education, Labor and Pensions Committee.
“We’re not going to rush it, the Senate never does. The likelihood is you couldn’t get anything on the Senate floor until the fall, so I don’t think we’re in any hurry,” said Sen. Richard Burr, who co-wrote a white paper with Alexander titled “Innovation for Healthier Americans” in January.
Added Sen. Patty Murray, the ranking member of the Senate HELP panel: “We’re taking our time to really look at all the issues. We don’t have a bill yet. We want to get it done right, but we’re focusing on higher ed first.”
The Cures legislation aims to boost National Institutes of Health funding and support of researchers and young scientists, streamline clinical trials, and establish a public-private partnership to accelerate the discovery, development, and delivery of cures, treatments, and preventive measures. It also would require the FDA to issue guidance in the development of biomarkers, precision drugs and biological products.
Upton said the bill should finish subcommittee markup Thursday and then will likely go through full committee markup next week. His goal is to have the bill on the floor in June, go to conference with the Senate in the fall and then send it to the president before the end of the year.
Following Obama’s State of the Union address in January, the White House unveiled the Precision Medicine Initiative, which would provide funding to accelerate biomedical research. Upton said the House was working “very closely” with the administration, using its precision medicine language and working closely with the FDA.
Timing isn’t the only difference between the House and Senate approach.
The amount of funding for the NIH is a sticking point. The House draft released Wednesday provides $10 billion of mandatory funding—$2 billion a year for five years—to the NIH Innovation Fund, as well as a reauthorization of discretionary funding.
“Two billion dollars a year for five years is certainly better than nothing, but let’s not pretend that a small temporary investment that falls billions of dollars short of what we’re going to need to do the job—there is a gaping hole in our NIH budget and we need a serious plan to fix it,” said Sen. Elizabeth Warren at last week’s Senate hearing on precision medicine. “Whatever we do, this committee has to get serious about medical innovation and that means we have to do better than the House proposal on this.”
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Alexander said that although it’ll have to be handled by the Appropriations Committee, he “would like to see more money for the National Institutes of Health.”
It’s also unclear the degree to which the House and Senate bills will differ and the scope of the Senate bill.
“Our bill is going to be more comprehensive because we started so much earlier, really a year. More than a year,” Upton said. “We’re hoping that they just do a smaller piece and then we can encapsulate it together. Their focus is on innovative medicine … it’ll be things we may not have, but we can certainly come to agreement.”
Although it seems the congressman is right about the Senate’s focus, it’s unclear whether it’s looking to put forward a “smaller” piece of legislation.
“Our objective is to align federal policies so that they encourage getting discoveries through the regulatory process more rapidly and into the medicine cabinets of doctors’ offices,” Alexander said, “so it’s going to be a broad piece of legislation.
“It will include the president’s Precision Medicine Initiative, and we’re on parallel tracks with the House,” he added. “They started earlier, and so it’ll be the end of the year before we finish our work. But it’ll be a very substantial piece of legislation. It has broad bipartisan support.”
Burr said the Senate’s version will focus on driving innovation and breakthrough technologies.
“Right now, the Cures Act is more disease-specific, and it’s talking about funding and NIH, and we’re looking at, how do we drive breakthroughs in health care?” Burr said. “I think ours is targeted to anything that would fall under the innovation umbrella, and that’s talking about 21st-century health care.”