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What’s in the 21st Century Cures Act for Precision Medicine?

- The 21st Century Cures Act, an expansive piece of legislation that provides new funding for the National Institutes of Health (NIH) and streamlines regulation for the pharmaceutical industry, passed a House vote with flying colors last week, garnering support from across the political spectrum as lawmakers jump on the chance to strengthen the nation’s growing precision medicine infrastructure and processes. 

21st Century Cures Act for precision medicine

After overwhelming approval resulted in a 344 to 77 vote on Friday morning, the bill will move to the Senate, which will consider adding $8.75 billion in funding to the National Institutes of Health, among other provisions.

“The history of health innovation is remarkable,” said House Energy and Commerce Committee Chairman Fred Upton (R-MI) during remarks in support of the bill. The past century has seen the medical field make immense strides in the diagnosis and treatment of hundreds of serious or fatal diseases, but regulatory processes have not been able to keep pace with the flood of innovation. 

Despite the growing interest in promoting genomics and precision medicine as a way to personalize care, clinical trials for promising therapies often suffer from funding droughts, while patients with rare conditions struggle to get access to potentially life-saving treatments due to red tape and insufficient information. 

These patients “aren’t interested in debating why the timelines, the failure rates, the size and the costs of conducting clinical trials are at all-time highs,” Upton said. “They just know that despite the promise of scientific breakthroughs, they can’t get the therapy that might save them. That is why we need 21st Century Cures.  This bill is about making sure our laws, regulations, and resources keep pace with scientific advances.”

The lengthy and wide-ranging bill contains a number of provisions that will immediately impact the nation’s efforts to foster precision medicine.  Some of the notable features of the 21st Century Cures Act (HR 6) include the following:

Five years of medical research and clinical trials funding for the National Institutes of Health and the Food and Drug Administration, totaling $14.25 billion.  The NIH will receive $1.75 billion in funding each year for biomedical research, while the FDA will receive $110 million per year.  This funding is offset by other savings in the federal budget, and may bring “dramatic savings” to the nation in the long term if researchers can reduce the economic burden of key diseases.  Clinical trials that may be high risk but also have the potential to produce high reward will be encouraged.

Establishment of big data analytics systems for disease surveillance and research.  In addition to encouraging the use of data standards for all patient information related to clinical trials, the 21st Century Cures Act would establish “a public-private partnership to establish or enhance and support an information technology system, including staffing, to collect, maintain, analyze, and interpret data on the natural history of diseases, with a particular focus on rare diseases.” 

The legislation would also require the Centers for Disease Control and Prevention (CDC) to create disease surveillance systems for neurological conditions such as Parkinson’s disease and multiple sclerosis.  A “third party scientific research sharing system for trials solely funded by the federal government” would also be established in order to allow researchers to exchange big data and conduct research using multiple sources of data.

Creation of the Council for 21st Century Cures.  This precision medicine group, intended as a public=-private partnership, would be charged with accelerating the “discovery, development, and delivery of innovative cures, treatments, and preventive measures for patients.”

Streamlining of the drug approval and clinical trial process.  The FDA will work with the pharmaceutical industry to accelerate the lengthy process of bringing promising new drugs to market.  In addition to regularly updating its guidance on the meaning and scope of “precision medicine” and its associated pharmaceutical products, the FDA will expand opportunities to test drugs for novel, off-label uses of existing products.  The FDA will also trim down its data review processes to ensure that applications move through the system in a timely manner.

Additionally, the FDA will produce expedited guidance for drug manufacturers on the warnings and information required for experimental or expanded access products.  The regulation of vaccines and new antibiotics to fight the growing prevalence of superbugs will also receive consideration.

Expanding access to breakthrough products and medical devices.  The FDA would create a priority review process for breakthrough medical devices that may have an immediate benefit for the industry.  In order to keep patients informed of the latest developments in medical research, CMS will establish a Medicare ombudsman for patients running to barriers when trying to access new and life-saving technologies.

Addressing health data interoperability, telehealth, and health IT adoption.  The Office of the National Coordinator will work with HHS to determine national standards for interoperability between electronic health records (EHRs) in order to encourage health information exchange and care coordination in the provider community.  The interoperability framework will be published in the Federal Register after review.

The Energy and Commerce Bipartisan Telemedicine Member Working Group will also receive support for their work to improve the adoption of telehealth technologies across the healthcare industry by spurring key government bodies into addressing the barriers to remote care adoption.

The White House has already expressed its approval of the bipartisan support for the legislation, though it does note that the bill contains certain imperfections.  A subsection of the Act would require the nation to sell oil from the Strategic Petroleum Reserve to fund some of the activities included in the package, and it also extends exclusivity rights for drug manufacturers to set prices and market products that are being used for new off-label purposes.

“The Administration appreciates the bipartisan interest in advancing the interoperability of health information technology and remains focused on the need to strengthen this critical foundation for delivery system reform and precision medicine,” the White House said in its statement. “The Administration looks forward to working with the Congress on continuing to improve the bill as it moves forward.”

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