(Recasts with bill passage, adds comments from White House,
By Toni Clarke
Nov 30 The U.S. House of Representatives on
Wednesday passed a sweeping, $6.3 billion bill that supporters
say will spur medical innovation, speed access to new drugs,
expand access to mental health treatment and battle the opioid
The 21st Century Cures Act had widespread bipartisan
support, including the backing of the Obama administration,
although critics have said it gives massive handouts to the
pharmaceutical industry while making cuts to public health
programs and the Medicare health insurance program for seniors.
Two years in the making, the legislation contains 19 core
bills, including measures to advance personalized medicine,
shorten drug approval review times and boost Alzheimer's and
cancer research. The House passed the bill by a vote of 392-26.
The Senate is expected to vote on it next week.
The White House said in a statement after the House vote:
"The Senate should promptly pass this bill so that the President
can sign it."
The bill, sponsored by Republican Representative Fred Upton
of Michigan, authorizes $4.8 billion to the National Institutes
of Health and $500 million to the Food and Drug Administration
to streamline the clinical trial process and hire new staff.
It also envisions $1 billion over two years to battle opioid
and heroin abuse and $1.8 billion to support Vice President Joe
Biden's Cancer Moonshot initiative, designed to speed research
into new cancer therapies.
Critics of the legislation, including Democratic Senators
Elizabeth Warren of Massachusetts and Jeff Merkley of Oregon,
and Democratic Representative James McDermott of Washington,
have said the funds may not ultimately be forthcoming as they
must be appropriated by separate funding bills.
In the meantime, changes to the FDA's regulatory authority
would be law. Those changes, critics said, would lower standards
for drug approvals and jeopardize patient safety.
"We put the FDA in the position of protecting the American
public and then we cut them out at the knees," McDermott said
before the vote, adding the bill would open the door for
companies "to push out any drug they want."
Money to pay for the bill would be offset by reductions in
other spending, including Medicaid payments for some medical
equipment and through the sale of oil from the Strategic
Petroleum Reserve, something the administration said "continues
a bad precedent of selling off longer term energy security
assets to satisfy near term budget scoring needs."
House Speaker Paul Ryan said the measure "is going to be a
game-changer," adding: "It will fundamentally transform the way
that we treat and cure diseases in this country."
A provision that would have made it easier for companies to
conceal payments to doctors under the guise of continuing
education was dropped at the last minute. Republican Senator
Charles Grassley of Iowa had opposed the provision.
"This is good news for transparency and the public,"
Grassley said in a statement on Tuesday. "With drug prices
through the roof, the way drug and device makers spend money is
of more public interest than ever."
Patient advocates support the bill, which requires that
their voices be brought more formally into the drug approval
process. Patients have increasingly put pressure on the FDA to
approve drugs even if evidence that they work is slim.
The bill expands access to mental health treatment and
services. Vern Buchanan, Republican representative from Florida,
called the provision "a breath of fresh air after decades of
(Reporting by Toni Clarke; Additional reporting by Richard
Cowan; Editing by Tom Brown and Peter Cooney)