The U.S. House of Representatives on Friday passed a sweeping bill to speed new drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it. According to the report in Reuters Health, the House voted 344 to 77 in favor of the 21st Century Cures Act, which would require the FDA to streamline its drug approval process, consider more flexible forms of clinical trials and incorporate patient experience into its decision-making process.
The bill was developed by the House Energy and Commerce Committee and spearheaded by Republican Fred Upton and Democrat Diana DeGette. A similar bill in the Senate is expected to be voted on before the end of the year. The program would be paid for with the sale of 80 million barrels of crude oil from the Strategic Petroleum Reserve (SPR) over eight years.
“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 Republican Senator Lisa Murkowski, 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 five years and increase funding to the Food and Drug Administration 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.