US FDA Seeks Support for the National Cancer Moonshot Initiative

FDA will develop a virtual Oncology Center of Excellence

On 9 February 2016, the US Food and Drug Administration (FDA) announced its request for a total budget of 5.1 billion USD to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget – an 8% increase over the enacted budget for FY 2016. The overall request includes a net increase for initiatives tied to several key areas, including 75 million USD in new mandatory funding to support the US National Cancer Moonshot initiative being led by the US Vice President.

The FY 2017 request covers the period from 1 October 2016, through 30 September 2017.

Supporting the National Cancer Moonshot Initiative

In order to support the dramatic increase in the number, complexity, and effectiveness of cancer diagnostics and therapeutics, the FDA will develop a virtual Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices. This center will expedite the development of novel combination products and support an integrated approach in:

  • evaluating products for the prevention, screening, diagnosis, and treatment of cancer;
  • supporting the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer; and
  • developing and promoting the use of methods created through the science of precision medicine.

Other highlights of the FDA FY 2017 budget include funds for Continued Implementation of a New Food Safety System, Improving the Safety and Quality of Medical Products, and Investing in the FDA’s Infrastructure.