FDA Publishes Wish List of Regulatory Science Projects, Plans to Spend up to $50 Million

Posted 24 May 2013 | By Alexander Gaffney, RAC 

US regulators have published a new agency contracting announcement regarding advanced research and development for regulatory science, saying it wants to "advance the state of the art and achieve improvements" in how healthcare products are evaluated, adding that it is prepared to spend as much as $50 million on the effort.


The term "regulatory science," which FDA defines as the "science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products," has been central to many of FDA's efforts in the last three years.

In issue after issue and appearance after appearance, FDA Commissioner Margaret Hamburg has touted the agency's focus on regulatory science, saying it's one way for regulators to better accomplish their jobs and avoid the scrutiny of skeptical politicians.

"Frankly, these days, at least in Washington, you are far more likely to hear the word 'regulatory' linked to the phrase 'job-killing' than to 'science,'" quipped Hamburg in an April 2012 appearance before a New England Healthcare Institute (NEHI) conference . "But believe me, this is a short-sighted view."

And neither Hamburg nor FDA seem likely to be in it for anything but the long term. In November 2012, the agency started a campaign intended to promote regulatory science to the public by explaining the field in plain terms.

But public outreach is just one part of FDA's efforts. The other, larger effort, involves working with various stakeholders to advance the various fields of regulatory science. In January 2013, for example, FDA issued a grant proposal calling for groups to help it address a number of regulatory science issues, including those related to the communication of risk. In December 2012, the agency announced it would partner with LifeScience Alley to ensure that the US maintains its status as "the leader in regulatory science." And in March 2013, FDA announced it plans to partner with the Brookings Institute's Engelberg Center for Health Care Reform to build new regulatory science capacity.

Wish List for Regulatory Science

But FDA's new solicitation, announced 23 May 2013, advances and clarifies its intentions for improving regulatory science at the agency still further, saying it plans to spend as much as $50 million in total (depending on congressional appropriations) on a series of efforts that could pay huge dividends for regulators and industry alike.

That spending, which will be split between several awards, will be focused on eight areas, FDA said:

  • the modernization of toxicology testing with the intent of enhancing product safety
  • the stimulation of innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
  • supporting new approaches to the improvement of product manufacturing and quality
  • ensuring FDA has the capacity to evaluate innovative emerging technologies
  • harnessing diverse data through information sciences to improve health outcomes
  • facilitating the development of medical countermeasures to protect against threats to US health and security
  • strengthening social and behavioral science at FDA by enhancing public and industry understanding
  • strengthening the global product safety net

All eight of those areas are explored extensively in FDA's solicitation notice, which acts as a wish list of sorts of the projects it hopes to accomplish in the coming months and years.

For example, FDA says it wants to:

  • develop better models to predict adverse events
  • identify new biomarkers and endpoints to be used in clinical trials
  • develop new computational models to predict human risk
  • refine clinical trial designs and analysis techniques
  • leverage existing clinical trial data to improve future ones
  • develop new and improved manufacturing and analytical methods
  • develop new high-speed technologies capable of detecting contamination in products
  • assess new ways of communicating with industry and the public

These tasks, as they often do, will fall to the private sector, FDA said.

FDA's document, known as a Broad Agency Announcement (BAA), may be found online here.

FDA: Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science

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