With Republicans just weeks away from possibly repealing the Affordable Care Act, President Obama’s signature domestic policy program, it may seem like an odd time to look for bipartisan unity on legislation related to health care. Nevertheless, Congress appears to be ready to pass a major bill funding medical research and overhauling the approval process for new drugs and medical devices.
The 21st Century Cures Act, which spans 25 separate sections touching on subjects as diverse as drug research and foster care, runs to nearly 1,000 pages. As with any piece of legislation so large, the bill is packed with elements that draw both praise and angry criticism.
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Rep. Fred Upton (R-MI), the chief sponsor of the bill, has called it "an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today."
By contrast, Vermont Sen. Bernie Sanders complains that the bill “provides absolutely no relief for soaring drug prices” and amounts to a gift to the pharmaceuticals industry. “The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer … It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.”
At the heart of the bill is a plan to fund the National Institutes of Health and to establish an “Innovation Prizes Program to fund areas of biomedical science that could realize significant advancements or improve health outcomes.” Beside the NIH program, the bill directs between $50 million and $75 million per year to the Food and Drug Administration over the next decade to create an FDA Innovation Account meant to fund further pharmaceutical research, including treatment for “agents that present national security threats.”
The bill also outlines various measures to streamline the approval of new drugs and medical devices and to make it easier for desperately ill patients to get access to experimental medications that have not yet been approved for the general population.
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Among the programs funded by the bill is the vaunted “cancer moonshot” being spearheaded by Vice President Joe Biden, who recently lost his son, Beau, to a brain tumor. The object of the program is to compress a decade’s worth of cancer research into a five-year period.
The bill directs the FDA to implement various new protocols in its system for approving new drugs and medical devices, with the aim of bringing them to market sooner and reducing the burden on companies developing potential breakthrough medications and vaccines. It also pays particular attention to the process for testing new antibiotic and antifungal medicines that can treat infections resistant to existing medications.
Another section of the bill takes on the spreading problem of opioid abuse and addiction. It sets aside half a billion dollars in funding to support state-level programs targeting the opioid crisis, including prescription drug monitoring programs, healthcare provider training, access to treatment and more.
But for all the elements of the bill that have wide support, there are others drawing fierce criticism.
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Democrats note that much of the funding for the bill is dependent on the coming reduction or elimination of the Affordable Care Act, meaning that it represents less new funding for health care than it does a simple transfer of funding from programs supporting direct patient care to research and development.
The bill also delves deeply into the weeds of Medicare policy, rewriting some rules on access to treatment and physician reimbursement, in ways that some critics worry will make it harder and more expensive for some seniors to get needed care.
In a speech on the Senate floor, Massachusetts Sen. Elizabeth Warren blasted the bill as a “giveaway” to big pharma that will have negative side effects, including making it more difficult for the disabled to get access to doctors under the Medicare program and taking funding away from Affordable Care Act programs. She described the funding of research programs at NIH as a distraction from the bill’s real purpose.
“Why bother with a fig leaf in the Cures bill? Why pretend to give any money to NIH or opioids?” she demanded. “Because this funding is political cover for huge giveaways to giant drug companies.”