The Food and Drug Administration regulates a quarter of the products that make up the economy of the United States, and yet while the dollar amount of activity it regulates continues to increase, the agency’s staffing has not. Rapid advances in basic science technologies have also added strain to the taxed agency. A 2007 FDA science board report found the capacity of the FDA is mismatched with the task it has to perform.

“Regulation has not kept pace with advances in science,” said Nancy Sung, a senior program officer at the Burroughs Wellcome Fund. “There’s a real need for people at the FDA to have an increased understanding of these technologies and come up with new ways of testing.”

In September 2011, the Burroughs Wellcome Fund provided support to gather scientists from academia and industry together with various biomedical funders to discuss workforce and training issues in regulatory science. The workshop, “Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development,” was held at the National Academies of Science in Washington D.C.

During the meeting, the most cited definition for regulatory science came from the Food and Drug Administration as the “science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.” While others tweaked or had their own interpretations for regulatory science, the consensus pointed to the FDA’s description.

A key objective of the workshop was to consider workforce development issues. A number of training programs already exist in academia and through the FDA. However, there is concern that a lack of funding and career support fails to draw qualified individuals to the field.

“We’re not just asking about having more people who can help companies or help run clinical trials,” said Dr. Sung. “Though there’s certainly a need for these individuals, what we’re looking at is the innovation needed to advance the science of regulation.”

Results from the September meeting found that, not surprisingly, regulatory science, because of its multidisciplinary nature, was difficult to pin down to one academic center or funding agency.

“It’s always easier to find a champion when something fits easily within the purview of a particular funding agency or institute,” said Elaine Gallin of QE Philanthropic Advisors and cochair of the planning committee. “People are sensitive to the importance of translating what we are finding in basic science into products in a more timely way, but regulatory science bridges many different fields and therefore does not have one clear champion.”

“The multidisciplinary nature of regulatory science is critical, but it can also be a challenge ,” said Dr. Gallin. “Folks won’t go into regulatory sciences as a focus area unless there’s a clear career track. What academic department would they belong to? Who would support them? Where would they get grants?”

Dr. Gallin noted one approach for advancing the field mentioned during the workshop is to try to reach a consensus on the most critical issues and problem areas in regulatory science that if addressed could move the field forward and then advocate to get different funding agencies to focus resources to support innovative work in those areas.

For more on this meeting, see the proceedings at: Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: An Institute of Medicine Workshop

By Russ Campbell, BWF Communications Officer