Congress weighs approval for sweeping, $6.3 billion 21st Century Cures Act

US_Congress_02It’s almost 1,000 pages,   culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the 21st Century Cures Act, a sweeping measure that some say could affect American health care as much as the Affordable Care Act aka Obamacare?

After the bitterly divisive presidential campaign, House members surprised many with their swift consideration of the health funding bill, which passed 392-26. Congressional leaders then crowed about how they can work together and how the legislation will help. The act now has moved to the Senate for consideration. Senators, notably Massachusetts Democrat Elizabeth Warren, have been far more critical of components of the measure, particularly how Big Pharma and device-makers may benefit.

I’ve written how Congress, around this time last year, provided holiday cheer by approving the framework of the 21st Century Cures Act, an omnibus bill that took a year for funding details to get worked out. Because the legislation covers so many health areas and still must be acted on by the Senate and signed by the president, it still needs wary watching. Lobbyists for many different causes already have had a field day on this bill, and they will continue to do so.

Two areas (discussed more below) created the most controversy and promise to do so in the Senate: the federal Food and Drug Administration (FDA) and its oversight on drugs and medical devices; the funding for the act.

The measure advanced out of the House appears to:

  • Significantly increase the budget (by $4.8 billion) of the National Institutes of Health, especially for research to fight Alzheimer’s and cancer. Advocacy groups praised this fiscal support, noting the key role that Vice President Biden had played, for example, in leading President Obama’s “moonshot” to beat cancer. This funding will benefit universities, medical schools, academic medical centers, major hospitals, and other research-conducting institutions. It also will support Obama’s wish for more research on the brain, and his “precision medicine” initiative, which seeks to involve patients more and to tailor care to them and their genes, lifestyles, and environments.
  • Provide much needed financing to battle opioid drug abuse, a dire problem that claims, by some estimates, as many as 80 American lives daily. The bill would provide $1 billion to fund treatment, prevention, and research.
  • Build up support nationwide for mental health, making it a priority, coordinating care, and raising the funding, particularly for clinicians who can demonstrate their programs work. Funding also would support efforts to keep the mentally ill out of the nation’s jails and prisons. States would get a new push from Uncle Sam to develop initiatives to intervene with psychosis patients.
  • Reduce support for preventive programs, including those aimed at cutting hospital acquired infections, curbing smoking, and dealing better with chronic illnesses. The House will do this by reducing by 30 percent funding for the Obamacare-created Prevention and Public Health Fund.

Big sticking point 1: The FDA and drug- and medical device-approvals

The FDA saw its funding increase by $500 million, a move that will help it address its many challenges, especially staffing. But the agency also became the focus of furious feuding over its processes for regulating Big Pharma and medical device makers. Early on, critics assailed efforts to relax, for example, rules that require doctors to report payments they get from drug makers for professional speeches. This item was stripped from the act.  As the bill advanced, opposition also built to changes in FDA processes that critics said would short-circuit the agency’s ability to ensure the safety and effectiveness of both drugs and medical devices. Proponents said FDA rules needed to be streamlined to get beneficial drugs and medical products to market sooner to help patients. Aspects of this fights got technical, involving battles over issues such as whether regulators must rely only on rigorous clinical trials or if they could accept “real world” evidence of that a drug or medical device works. Should they race to approve a drug, for example, that shrinks tumors but does not extend patients’ lives? Warren asserted the cures act had been “hijacked” by Big Pharma, and pledged to fight it in the Senate, “because I know the difference between compromise and extortion.” President Obama has said the act has flaws but the administration supports it.

Big sticking point 2: Paying for a $6.3 billion bill

Funding the 21st Century Cures Act also became a major issue. That’s because Republicans, who a year ago pledged to support the measure but said they wanted to figure how to pay for it, made much of the bill’s financing year-to-year, requiring annual renewal. Much of the money for the act will come from sales of stores from the strategic petroleum reserves, plus the cuts in Obamacare’s preventive health programs and reductions in specified Medicare programs. Some GOP legislators objected to the act, saying it increases spending and the size of government.

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