- Lawmakers anticipating a tough landscape for innovation funding under a new Republican administration are doing their best to push a revamped version of the 21st Century Cures Act through the current Congress, and will bring the $6.3 billion precision medicine and medical research package to a House vote on Wednesday, November 30.
The bill, which passed the House with flying colors in July of 2015, provides a huge bump in funding for the National Institutes of Health and the FDA, both of which have been heavily involved in the national Precision Medicine Initiative, the Cancer Moonshot, and dozens of smaller projects intended to foster an interoperable ecosystem of cutting-edge research and big data analytics.
The legislation would also allocate $1 billion in state grants to fight opioid abuse and significantly update certain mental health programs.
"It is time to vote on 21st Century Cures, mental health legislation, and help fund the fight against opioid abuse. It will advance President Obama’s personalized medicine initiative, Vice-President Biden’s cancer moonshot, Alzheimer’s research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors’ offices," said House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN).
“What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day. And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in Fiscal 2017.”
Under the legislation, the NIH would receive $4.8 billion to fund precision medicine projects, including $1.4 billion for the PMI, $1.8 billion for Vice President Biden’s Cancer Moonshot, and $1.6 billion for the BRAIN Initiative to delve deeper into the causes and potential treatments for neurological conditions like Alzheimer’s disease.
It would also address issues involved in bringing new therapies and medical devices to market by streamlining the review and approval process, increasing patient involvement in clinical trials and other testing mechanisms, and refining oversight for Internet of Things devices, mHealth apps, and wearables that walk the line between consumer-grade tools and clinical products.
The House Ways and Means Committee has also attached a number of bills to the package, many of which focus on reducing regulatory burdens for hospitals, expanding participation in value-based care programs for rural hospitals, and helping to empower patients to seek innovative care and retain health insurance coverage options.
The impending vote has generated strong passions both for and against the landmark legislation.
“This is a patient-focused bill that will advance the discovery and development of treatments, strengthen the patient voice in the research and regulatory environment, increase funding for the NIH and FDA, and greatly improve our innovation ecosystem,” said a letter from the National Health Council, which included the signatures of 217 patient advocacy, medical research, and awareness organizations.
“Millions of Americans are desperately waiting for effective treatments and cures for their chronic disease or disability. The organizations that represent these people with chronic conditions urge Congress to pass the 21st Century Cures Act in 2016 in order to speed the development of treatments and cures. Patients simply can't afford to wait -- time is running out.”
But unchecked speed may be dangerous, especially when it comes to pushing new therapies through a less rigorous approvals process, argued a number of stakeholders on the other side of the debate.
At an emergency Senate briefing earlier in November, opponents of the bill raised concerns about loopholes in the FDA’s market readiness processes that have allowed millions of devices to move through an expedited pathway known as 501(k).
"Over a 1-year period, almost half a billion 510(k) approved devices were recalled as high-risk, some having caused death,” said Dr. Diana Zuckerman, president of National Center for Health Research.
Trimming back the need for comprehensive review without rectifying fundamental problems with the FDA’s inner workings may do more harm than good for patient safety, added Jonathan Emord, Esq. “We each recognize there are deep problems within the FDA that have resulted in dangerous drugs and medical devices on the market.”
"Though the FDA's medical scientists may recommend rejecting a product, too often political managers, beholden to industry, override them and grant approval. This bill comes at a time when the FDA is broken. Without rectifying this, the bill gives more power and discretion to the agency managers responsible for the dangerous products."
Despite the objections, lawmakers on both sides of the aisle seem eager to equip the NIH and FDA with the financial support required to make progress with personalized medicine and precision therapies.
“The Cures Act will improve the lives of Americans from all walks of life for generations to come,” said Ways and Means Committee Chairman Kevin Brady (R-TX).
“This historic legislation will finally empower our scientists, researchers, and doctors with the tools they need to solve some of the biggest health challenges of our time. I look forward to passing this legislation through the House and moving one step closer to delivering Americans 21st century cures.”