The bipartisan 21st Century Cures Act, headed to the Senate after passage in the House by a huge margin—392 to 26—is meeting with mixed reactions by many.
Some of its best features are money to fight the opioid epidemic, funding for National Institutes of Health projects—the cancer “moonshot,” the BRAIN Initiative and the Precision Medicine Initiative—and support for mental health.
|Benefits to the pharmaceutical industry
But Business Insider reported that on the flip side are features that spurred former supporters of the bill Senators Elizabeth Warren, D-Massachusetts, and Bernie Sanders, I-Vermont, to withdraw their backing, with both declaring it a giveaway to the pharmaceutical industry.
Among other changes, drug companies will no longer have to submit full clinical trials for approval, but will be able to submit “data summaries” to get drugs approved for new indications, and they will also be able to promote “off-label” drug uses to insurers.
That could mean that it will be faster and easier for pharmaceutical companies to win approvals—but those newly approved drugs won’t necessarily have undergone all the safeguards formerly in place.
Ditto for medical devices, which will also have fewer hoops to jump through and a faster road to approval.
|Less money for NIH, FDA ongoing needs
The $6.3 billion bill’s provisions for the NIH were supposed to be guaranteed funds, but now are subject to discretionary funding—so even though there’s $4.8 billion for NIH’s projects, it will have to be appropriated by Congress in the future—by no means a sure thing.
The FDA got $500 million under the Act, but before you cheer, the money is for its new tasks conferred by the Act. It didn’t get much of anything to tackle its own longstanding needs, such as food safety and post-approval oversight of medical products that went through the fast track.
And there’s no money for renovation of labs outside of headquarters, despite deterioration over time.
Not only were Senators Sanders and Warren disappointed in their quest to halt the bill’s passage, many patient advocacy groups also have been disappointed by the reduced funding provided to many worthy recipients.
The bill is expected to pass the Senate.
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