Billion-Dollar Cancer ‘Moonshot’ Plan Includes $75M in New Funds for FDA

Regulatory NewsRegulatory News | 01 February 2016 |  By 

The White House’s $1 billion proposal to fund Vice President Joe Biden's “Moonshot” cancer initiative also includes several proposed investments in federal agencies, including $75 million for a new center at the US Food and Drug Administration (FDA).

President Barack Obama’s State of the Union address singled out Biden as the leader of the expansive initiative that so far has few details, and which has raised some serious doubts from cancer researcher Vinay Prasad (who also wrote about cancer drug pricing for Focus last month) and skepticism around the rhetoric.

Task Force

On Monday, Biden held the first task force meeting alongside FDA commissioner nominee Robert Califf, National Institutes of Health (NIH) Director Francis Collins and Doug Lowy, acting director of the National Cancer Institute, among others.

Details of the plan were slowly emerging, with expectations for President Barack Obama to ask Congress for $755 million for fiscal year 2017, and an initial spend of $195 million this year for NIH, which Congress already approved as part of a budget deal.

“The ‘Moonshot’ metaphor may have limitations but we are at a moment where dramatic acceleration of progress is possible,” Collins said after the meeting Monday.

FDA Funds

The new FDA funds, which still need approval from Congress, would help create a new virtual Oncology Center of Excellence and new data sharing initiatives.

According to a fact sheet from the White House, FDA will develop this virtual center to leverage the skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices.  The center will expedite the development of novel combination products and support:

  • 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 Focal Points

Other areas of focus are expected to include: Early cancer detection technology, rare pediatric cancers, cancer vaccine development, immunotherapy and combination therapies, more genomics analysis, better data sharing and more promotion of cancer drug trials.

“Right now, only five percent of cancer patients in the United States end up in a clinical trial,” Biden wrote recently of the initiative. “Most aren’t given access to their own data. We need to figure out how we can reduce costs and expand access to these trials.”

The Obama White House is also expected to ask for additional funding for the Pentagon and Veterans Affairs for "centers of excellence" on specific cancers.

And a Blue Ribbon Panel will be formed to shape the scientific goals of the project, reporting through the National Cancer Advisory Board, Collins said Monday, though no public timelines have yet to be established.

Fact Sheet

Memorandum -- White House Cancer Moonshot Task Force


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