The US Senate on Wednesday passed a 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, Reuters reports.
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, it’s 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 US$6.3 billion act, sponsored by Republican Representative Fred Upton, authorizes US$4.8 billion for the National Institutes of Health and US$500 million to the Food and Drug Administration.
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