House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) is aiming to have as many as 350 votes or 80% of the members of the House to back the 21st Century Cures Act, also known as H.R. 6.
Upton made the announcement during a Tuesday news conference surrounded by other members of Congress from both sides of the political aisle and patients battling a variety of illnesses including lupus and multiple sclerosis. The bill now has 131 co-sponsors, made up of half Republican and half Democrats. Achieving the 80% goal would send the right signal to the Senate, with the hope that they would quickly pass their own version of the bill, he said.
Upton declined to say when H.R. 6 would actually hit the floor, other than “soon.” He said there were some last minutes details that need to be ironed out, including possible amendments from members of the House, but wouldn't provide additional details. Some reports have mentioned the bill's vote has been stymied by politics. Upton reiterated that he is confident that with the bipartisan spirit behind the bill, it will be signed by the president by year's end. Last month, H.R. 6 passed the House Energy and Commerce Committee 51-0.
In policy circles, Upton has indicated that he wants the bill to be voted on in the House prior to the release of the King v. Burwell ruling to ensure it gets adequate attention, a Hill insider who spoke on background said. Upton and Rep. Diana DeGette (D-Colo.), a ranking member of the Oversight and Investigation Subcommittee have been meeting with their Senate counterparts in an attempt to have something move this year, but they are much further behind in drafting a counterpart bill, making the year-end timeline an uncertainty, the individual said.
H.R. 6 provides more than $10 billion in funding over five years to the National Institutes of Health, as well as $550 million in added funds for the Food and Drug Administration. It also streamlines the regulatory pathway for drugs and medical devices.
Funding would come from the sale of crude oil from the Strategic Petroleum Reserve, as well as limiting the Medicaid reimbursement that states receive for buying certain durable medical equipment to the Medicare rate.
The bill has received some criticism, most notably from recently departed FDA Commissioner Margaret Hamburg.
“There's a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well,” Hamburg said days before she departed the agency in March.
She also criticized the law for giving the agency more responsibilities without an adequate amount of additional funding.
Lawmakers at the news conference defended the law against such criticism. “We know we're putting more on the backs of the FDA, but we're also dramatically increasing funding for the FDA,” Upton said.
On the issue of safety, both DeGette and Health Subcommittee Ranking Member Frank Pallone Jr. (D-N.J.) vouched for the law.
DeGette noted that the bill pushes both for increased consumer participation on advisory panels that recommend if a medical product is safe and effective and it beefs up post-market surveillance activities.
“We are the world standard for drugs and devices and we intend to meet or exceed that,” DeGette said.
Pallone added that after numerous drafts and countless meetings with stakeholders, patients will be protected.
“We know that the status quo needs some changes," Pallone said. “We have figured out how to improve things and still keep people safe.”
