Faster pathways in 21st Century Cures Act may not be enough, health care scholar says
"The 21st Century Cures Act aims to accelerate the approval processes for drugs and medical devices," Robert Graboyes, senior research fellow and health care scholar at George Mason University's Mercatus Center, recently told Patient Daily. "The faster pathways may help, but not enough, I fear. Last year, Richard Williams, Adam Thierer and I outlined the misaligned incentives innovators face when they engage with the Food and Drug Administration (FDA). In a shorter piece, I summarized our concerns the FDA has a built-in bias toward excessive risk-aversion that permanently slows and stifles innovation."
By contrast, the European Union uses multiple private, competing agencies to perform the tasks generally assigned to the FDA in the U.S., an institutional structure that leads to faster, cheaper, more predictable pathways, Graboyes said.
"The procedural changes in the 21st Century Cures Act may improve things, but will still leave us a long way from the ideal," he said.
Worth $6.3 billion, the much-anticipated legislation is supposed speed up approval for medical devices and drugs, as well as establish a framework for sweeping medical research for a wide variety of illnesses, including Alzheimer’s and drug addiction.
While critics have called the act a huge handout to big pharma disguised as badly needed research funds, the act received bipartisan support. It passed both branches of Congress before being signed by President Barack Obama.
In his recent op-ed piece published by the Washington Examiner, Graboyes referred to the act's Eureka Prizes Competitions -- retrospective monetary rewards aimed at achieving specific, well-defined technological goals. The idea reverses usual paths to government support for research and development, Graboyes stated in the article.
"The Eureka Prizes, in contrast, could well go to puppet-makers, clockmakers, actresses, teenage computer jocks, country doctors and garage tinkerers of all manner," he said. "If the prizes come to pass, the results will be fascinating to watch."
Graboyes' op-ed piece was published the day before the U.S. Senate's landslide 85-13 cloture vote on the act. Even prior to its ultimate approval, the cloture vote served as an indicator of the act's final passage in the Senate.
The 21st Century Cures Act did not enjoy universal support, however. Among the 13 senators who voted no in the cloture vote were Sen. Bernie Sanders (D-VT) and Sen. Elizabeth Warren (D-MA).
In particular, Warren criticizes the act for providing only a fig leaf of funding for the National Institutes of Health and the FDA while funneling billions to large pharmaceutical companies.
"I will fight this bill, because I know the difference between compromise and exploitation," she said in a Nov. 28 Senate floor speech.
Graboyes, in his comments to Patient Daily, declined to wade into that debate.
"I'll have to leave the Sanders-Warren question to others," he said. "That's a political question, and I focus on economics and policy."
The 21st Century Cures Act is not the only legislation Graboyes has been watching.
"I watch lots of legislation," he said. "Of course, I'm watching what the new Congress and President will do with the Affordable Care Act. But right now, much of my focus is on state legislation, which I believe to be every bit as important as what is occurring at the federal level."
Graboyes referred to the Mercatus Center's recently released Healthcare Openness and Access Project. In that project, Graboyes, obstetrician-gynecologist Darcy Bryan and Health Policy Fellow Jared Rhoads produced a database of state health care policies, a set of state-by-state-rankings, a paper with their findings and dozens of auxiliary documents.
"In the project, we considered dozens of ways that states can promote or inhibit advancements in health care: telemedicine, nurse practitioners, medical licensure, experimental drugs, structure of medical businesses, taxation, insurance and so forth," Graboyes said. "These issues will be as vital as the 21st Century Cures Act or the fate of the Affordable Care Act."
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