In July, the US House of Representatives passed the 21st Century Cures Act by a vote of 344-77 in an uncharacteristic show of bipartisanship.
With an aim to provide patients with cutting-edge treatments sooner and markedly drive down healthcare costs, the bipartisan agreement pledges to deliver $8.75 billion toward the National Institutes of Health over the next five years. It also assigns $550 million for the Food and Drug Administration and authorizes the agency to conduct a new priority review process for some antibiotics and an expedited approval pathway for medical devices, among other new responsibilities.
Today, the bill sits in the Senate Health, Education, Labor and Pensions (HELP) Committee, which has been working on its own version of a “medical innovation bill” to mirror the House’s efforts, according to Renee L. Cruea, executive director of the Academy of Radiology Research.
The bill’s supporters include academic research universities, venture capitalists in the medical sector, patient advocacy communities, and the pharmacy, biotechnology and drug and device industries. However, some have voiced concern over the legislation’s consequences. Specifically, an opinion piece in The New England Journal of Medicine, authored by two Harvard professors, cautioned that speedier FDA approval could lead to adverse outcomes in patients, since the process is less rigorous than a full clinical trial.
Nevertheless, Cruea believes the legislation provides a much-needed lift for medical innovation. “It reinvigorates the medical research and the NIH with a desperately needed shot of new funding,” she pointed out.
Cruea shared that she holds a unique perspective on the legislation.
“Working as an executive director for the Academy of Radiology Research and advocating for research, I am aware that this legislation is very important from a scientific research perspective,” she said. “However I am also a patient—as most of us are—with type 1 diabetes, and I know first-hand that no single patient has the same experience with their ‘disease/chronic condition’ and that precision medicine, validated biomarkers and a re-design of the system that will get innovative technologies to us quicker and safely, is incredibly valuable to patients.”
“It is so important that we do what we can to push the envelope not only in terms of funding the research, but how we do research—collaboratively and with real patient input’and ensuring that those efforts get to the patient as quickly and as safely as we can,” Cruea said. “This legislation is a fantastic start to what I think could be a huge win for all of us, as we are all patients, and we will all benefit from this legislation, which I view as an investment on so many levels. It is easy to overlook that most legislation has a real human side, a perspective that I feel isn’t expressed as often as it should be.”
It is not clear how much of the House’s plan the Senate will be incorporating into its own draft bill, and what the timeframe will be. According to Cruea, there are indications that that the Senate will not have a public version of the bill to release until later this year or early next year.
“The Senate’s preference to start fresh on their own piece of legislation – as opposed to just taking the House’s version and working off of that if they preferred any changes – could increase the chance that neither bill eventually becomes law, as it could become difficult to eventually ‘conference’ the two bills into one final bill for both chambers to pass and send to the President,” she said.
Still, Cruea remains hopeful. “The Academy is very grateful for the House’s deliberate and transparent process by which it put the 21st Century Cures Act together,” she said. “We hope that the Senate follows a similar path, which it has done already through a number of hearings and listening sessions. We just hope it can finish up its thoughts as soon as possible so all of these new provisions aimed at improving patient care and capitalizing on research discoveries can become a reality.”