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 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."
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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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