Bipartisan 'Cures' Bill Easily Passes in House

November 30, 2016

The House today overwhelmingly approved a $6.3 billion, 1000-page piece of healthcare legislation with seemingly something for everyone — oncologists, neurologists, and psychiatrists included — which might have made it harder for lawmakers to reject its more controversial provisions.

The bipartisan measure, called the 21st Century Cures Act, is best known for speeding up the development and approval of new medications and medical devices by the US Food and Drug Administration (FDA). An earlier, leaner version of the bill easily passed in the House last year, but not without consumer advocates warning that regulatory corner-cutting could translate into less safe and effective "cures" reaching the marketplace. An editorial in the trade magazine Modern Healthcare, not exactly a fringe publication, called the bill the "21st Century Quackery Act."

In addition, the 2015 measure would have poured billions of more dollars into the National Institutes of Health (NIH).

The Cures bill approved today in a 392-to-26 vote went beyond the 2015 version by strengthening mental health services and helping states combat the scourge of opioid abuse and overdose deaths, causes that enjoy widespread support in the healthcare world and beyond.

The Senate is expected to approve the measure next week. Backers anticipate that President Barack Obama will sign it into law.

One of the most applauded parts of Cures gives $4.8 billion over 10 years to the NIH for research projects that include the Cancer Moonshot, the Precision Medicine Initiative that seeks more customized patient care, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and regenerative medicine using stem cells. Groups such as the American Society of Clinical Oncology like increased funding for the Cancer Moonshot, while neurologists like more money for the BRAIN Initiative.

Discoveries at the NIH presumably would result in more drugs and medical devices coming to the FDA for review. How they get a green light would change under the Cures legislation. The FDA may rely less on randomized clinical trials, for example, when it considers a new indication for a drug already on the market. The Cures bill directs the agency to study how it might use "real world evidence" from observational trials, clinical registries, insurance claims, and FDA safety surveillance to decide on a second indication.

The legislation also seeks to shorten the time it takes to develop a new drug by having the FDA judge its efficacy based in part on biomarkers — a metabolite, for example — that may predict a patient's response to the therapy. Critics say such surrogate endpoints are poor substitutes for outcomes such as a longer life or fewer complications.

The FDA would receive an additional $500 million over 10 years to carry out its Cures marching orders, all the while "maintaining the same standard for safety and effectiveness," according to a summary of the bill posted on the website of the House Energy and Commerce Committee. Cures also would give the FDA a greater ability to recruit and retain top-flight scientists to fill some 500 job vacancies.

Not surprisingly, drug and medical-device makers have been keenly interested in Cures becoming law. Kaiser Health News recently called it one of the most heavily lobbied healthcare bills in recent history, with some 1500 lobbyists arguing for or against passage.

A Boost for Mental Health Treatment

The mental health reforms of Cures are recycled from a bill called Helping Families in Mental Health Crisis, which the House passed 422-to-2 in July. Cures would create a new post in the US Department of Health and Human Services called the Assistant Secretary for Mental Health and Substance Use. Its occupant would coordinate mental health programs across federal agencies and generally exert stronger leadership in this sphere.

Other provisions create suicide-prevention programs, improve mental health services for children, fund more programs for court-ordered outpatient treatment, promote evidence-based research, and expand the mental health workforce.

In a related vein, Cures infuses $1 billion over 2 years into the federal government's campaign to treat and prevent opioid abuse. The money will be funneled to state programs that monitor drug prescribing, treat individuals addicted to prescription painkillers, and train clinicians.

To underwrite its spending agenda, the legislation would, among other things, sell off roughly $1 billion dollars' worth of oil from the national Strategic Petroleum Reserve and take $3.5 billion from the Prevention and Public Health Fund created by the Affordable Care Act, which Congressional Republicans and President-elect Donald Trump want to repeal.

Follow Robert Lowes on Twitter @LowesRobert


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