(Reuters) — The U.S. House of Representatives last week passed a sweeping bill to speed new medical devices and drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it.
The House voted 344-77 in favor of the 21st Century Cures Act, which would require the FDA to streamline its approval process, consider more flexible forms of clinical trials and incorporate patient experience into its decision-making process.
The program would be paid for with the sale of 80 million barrels of crude oil from the Strategic Petroleum Reserve over 8 years.
The bill was developed by the House Energy & Commerce Committee and spearheaded by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.). A similar bill in the Senate is expected to be voted on before the end of the year.
“The strong bipartisan support for the Cures Act in the House, together with broad support from the Obama Administration, are strong indications that the Senate will approve the Cures Act with small changes,” said Ross Muken, an analyst at Evercore ISI, in a research note.
One challenge may come from Sen. Lisa Murkowski (R-Alaska), head of the Senate Energy Committee, who has said she opposes the use of SPR sales to fund anything other than national energy security.
The House bill would increase funding to the National Institutes of Health by nearly $8.75 billion over 5 years and increase funding to the FDA by $550 million over the same period.
The bill would overhaul the FDA’s regulatory framework for approving drugs. It would create incentives for companies to develop drugs for rare diseases. It would allow certain antibiotics to be approved based more limited testing and establish other measures to shorten the drug development time.
