(Updates with analyst comment)
By Toni Clarke
WASHINGTON, July 10 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.
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 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 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 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.
(Reporting by Toni Clarke in Washington; Editing by Emily
Stephenson and David Gregorio)