21st Century Cures Act Now a Law

by Karl Kapp

 

In one of his last acts as President of the United States, Barack Obama signed the bill which allocated $6.3 billion to fund various efforts to eradicate cancer.  The efforts include money to fund drug treatment and research as well as money for seven years of funding for other health-related initiatives.

 

The additional funding includes $1.5 billion for a brain research initiative, $1.4 billion for precision medicine, and $1 billion for substance abuse treatment targeting heroin and opioid addiction.

 

A number of interesting provisions are in the bill. These include:

 

The establishment of the NIH and Cures Innovation Fund. The fund is to be used:

  • for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators;
  • to develop and implement a strategic plan for biomedical research;
  • to carry out specified provisions of this Act.

 

Additionally, the bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. It also indicates that the NIH must establish an Innovation Prizes Program to fund areas of biomedical science that could realize significant advancements or improve health outcomes.

 

Other provisions include:

  • The NIH must standardize data in the clinical trial registry data bank.
  • The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data.
  • The Centers for Disease Control and Prevention (CDC) must expand surveillance of neurological diseases.
  • The Department of Health and Human Services (HHS) must revise health information privacy rules to allow: (1) use of protected information for research purposes to be treated as use for health care operations, (2) remote access to information by researchers, and (3) individuals to authorize future use of their information for research.

 

The bill also established the Council for 21st Century Cures, a nonprofit corporation to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.

 

As the provisions of the bill are enacted, it will be interesting to track the progress of the fight against cancer and to see how this “increased urgency” impacts the disease.


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