A participant prepares to receive an antibody
infusion of a drug that is part of a clinical
trial for a functional HIV cure at the National
Institutes of Health in Bethesda, Maryland, U.S.
November 22, 2016 in this still image from
video.
The U.S. Senate voted overwhelmingly on
Wednesday to support sweeping legislation that
will reshape the way the Food and Drug
Administration approves new medicines.
It will also provide funding for cancer and
Alzheimer's research, help fight the opioid
epidemic, expand access to mental health
treatment and advance research into precision
medicine.
Two years in the making, the 21st Century
Cures Act was passed last week by the House of
Representatives and will now go to President
Barack Obama to sign into law. Supporters say it
will speed access to new drugs and devices, in
part by allowing clinical trials to be designed
with fewer patients and cheaper,
easier-to-achieve goals.
"For the second consecutive year, the Senate
is sending the President another Christmas
miracle for his signature," Senator Lamar
Alexander, a Republican from Tennessee said in a
statement. "Last year, it was the Every Student
Succeeds Act, and this time, its the 21st
Century Cures Act a bill that will help
virtually every American family."
Critics of the legislation say it gives
massive handouts to the pharmaceutical industry
and will lower standards for drug and medical
device approvals.
"This gift which 1,300 lobbyists, mostly
from pharmaceutical companies, helped sell
comes at the expense of patient safety by
undermining requirements for ensuring safe and
effective medications and medical devices,"
consumer watchdog Public Citizen said in a
statement.
Democratic Senator Elizabeth Warren was among
the handful of senators who voted against the
bill, as was independent senator and former
Democratic presidential candidate Bernie
Sanders. Each decried what they described as big
handouts to the pharma industry. Even so the
bill passed 94-5. The House passed it by a vote
of 392-26.
The $6.3 billion act, sponsored by Republican
Representative Fred Upton, authorizes $4.8
billion for the National Institutes of Health
and $500 million to the Food and Drug
Administration.
It also calls for $1 billion over two years
to battle the opioid epidemic. On Tuesday the
Drug Enforcement Administration issued a report
showing that in 2014 about 129 people died every
day as a result of drug poisoning. Of those, 61
percent are opioid or heroin related.
"Opioids such as heroin and fentanyl - and
diverted prescription pain pills - are killing
people in this country at a horrifying rate,"
Acting Administrator Chuck Rosenberg said. "We
face a public health crisis of historic
proportions."
The bill also calls for $1.8 billion in
funding for Vice President Joseph Biden's Cancer
Moonshot initiative designed to bolster cancer
research by reducing bureaucracy and promoting
research collaboration.
Critics note that the money described in the
bill must be appropriated by separate funding
bills and that the money may ultimately never
materialize. Yet the changes to the clinical
trial process, something long sought by the drug
industry, will be set in stone regardless of
whether money for the research projects is
forthcoming.
Among those changes: Greater prominence will
be given to "real world" evidence gathered
outside the framework of a randomized,
controlled clinical trial, the gold standard for
determining whether a drug is safe and
effective. Such evidence could be much easier
for drug companies to collect.
"The passing of 21st Century Cures Act is a
show of extraordinary bipartisan unity after a
divisive election that should be celebrated,"
said Ellen Sigal, chair of the patient advocacy
group Friends of Cancer Research.
Under the Act patient input will be formally
incorporated into the FDA's drug review process.
Funding for the Act will be offset by
reductions in some Medicaid payments and through
the sale of oil from the Strategic Petroleum
Reserve. The White House supports the bill but
said earlier it was concerned that draining the
Petroleum Reserve "continues a bad precedent of
selling off longer term energy security assets
to satisfy near term budget scoring needs."
(Reporting by Toni Clarke in Washington;
editing by Leslie Adler and Tom Brown)
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http://www.reuters.com/article/us-usa-health-senate-idUSKBN13W2KX