(Story updated at 2:45 p.m. Eastern.)
In a rare act of bipartisanship, House members voted 344-77 on Friday in favor of the 21st Century Cures Act, which supporters say will speed the development and regulatory approval of medical breakthroughs. Critics say that speed would come at the expense of patients' safety.
The legislation would provide an additional $9.3 billion in mandatory funding over the next five years to fund the National Institutes of Health and establish a Cures Innovation Fund to support work toward breakthroughs in biomedical research. It also provides $550 million in added funding to the Food and Drug Administration over the same period.
Supporters of the legislation say it will remove regulatory roadblocks in the FDA review process for medications and medical devices.
It has received strong support from both the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association. The industry groups argue that the bill would make the review process more efficient and less cumbersome, reducing the costs of bringing a product to market and ultimately lowering the cost of those therapies for patients.
A key provision would change the FDA's current “breakthrough therapy designation,” a program that began as part of the 2012 FDA Safety and Innovation Act. That law allows the agency to identify drugs whose early clinical evidence shows they may be a significant improvement over current treatments for a serious or life-threatening disease or condition in order to help speed up their review.
The bill would also allow the FDA to grant market approval to a drug with breakthrough designation based on its early-stage testing for safety and effectiveness. After starting to market the drug, the drug's manufacturer would be required to conduct clinical trials to demonstrate safety and effectiveness. Medical-device makers also would be able to apply for breakthrough designation for products that treat conditions where no alternative exists or that significantly improve on approved therapies.
A report released by the Congressional Budget Office last month estimated the program would cost $106 billion to implement beginning in fiscal 2016 through fiscal 2020 but would ultimately reduce federal spending by as much $12 billion over the next 10 years because of a series of funding offsets, including oil sales from the Strategic Petroleum Reserve.
The bill also has its critics, who say it would loosen FDA review standards and allow therapies to be sold before enough clinical data is gathered to determine whether they are safe and effective.
“What they're doing is that they're replacing the burden of proof for drug companies and device companies with a burden of uninformed decisionmaking for patients and doctors,” said Diana Zuckerman, president of the National Center for Health Research, a Washington D.C.-based not-for-profit patient-advocacy organization. “You're replacing the burden of proving that your product works with the burden of having expensive products on the market that may or may not work.”
Some supporters have criticized the bill for a provision that would extend market exclusivity to already approved drugs for as much as six months if they are approved to be repurposed for use in the treatment of rare diseases and conditions.
The Senate is working on legislation that's similar to the Cures Act, according to a staffer with the Health, Education, Labor and Pensions Committee. The committee has held four hearings over the past year on drug and device innovation and plans to generate a bill by the end of the year.
Sen. Patty Murray (D-Wash.), the HELP Committee's ranking member, praised the House for Friday's vote and said she looks forward to working on legislation aimed at medical innovation with the leaders of the Energy and Commerce Committee, which drafted the Cures Act.
Passage of the bill came just after lawmakers voted down an amendment introduced by Rep. Dave Brat (R-Va.) that would have shifted the legislation's funding from mandatory to discretionary spending, a move that would have torpedoed the bipartisan support. The amendment would have made the funding subject to yearly appropriation and authorization by Congress.
Many of the bill's Democratic backers would have voted against the legislation if the amendment had been adopted. Debate over the amendment pitted Republicans who wanted to see the legislation pass with broad support against more fiscally conservative GOP lawmakers who wanted tighter controls on spending.
“I would rather that we have everything discretionary, I wish the whole federal budget was discretionary except for Social Security,” said Rep. Joe Barton (R-Texas), during a debate on the measure. “But it's not. Let's come together and let's vote for something that we can all be proud of.”
The amendment ultimately got a small majority of Republican support during a final vote on the measure, while almost all Democrats voted against it.
“The increased mandatory funding for the NIH drives home the importance of innovation and medical research in the healthcare community's efforts to improve patient outcomes through new treatments,” Dr. Kim Allan Williams, president of the American College of Cardiology, said in a statement.
