It’s been eight years since the FDA Science Board released its “FDA Science and Mission at Risk” report; that report painted a stark picture of FDA’s capabilities, in particular its inability to fulfill its mission due to an “eroded” science base and “weak” scientific organizational structure. That report also called the agency out in terms of both the capacity and capabilities of its workforce, and its “inadequate” IT infrastructure. It was a persuasive document used by advocacy groups like the Alliance for a Stronger FDA to lobby Congress for additional appropriations for FDA in order to plug the gaps and strengthen the agency.
What has changed since then? Well, a lot.
The 2007 report was a wakeup call for the agency, and led to some significant changes. To name just a few, FDA eventually:
- Received significant increases in its appropriations to complement user fees
- Created its Advancing Regulatory Science strategic plan
- Established a centralized campus (White Oak) with state-of-the-art labs
- Prioritized food-related responsibilities to ensure they would not divert resources from other commitments
- Improved its review of generic drugs
- Improved its handling of imported drug products
Overall, the progress report finds that FDA “has implemented many of the Science Board’s recommendations for improving the infrastructure, management, and application of regulatory science to enhance its regulatory mission.”
But at the same time, as Martin Philbert, PhD, Chair of the Science Board’s Science Looking Forward Subcommittee said recently, some of the same themes from 2007 persist today. Echoing what FDA leadership has said for years, Philbert noted that the agency is still dealing with the twin realities of increased responsibilities and strained resources.
His conclusions are based the subcommittee’s evaluation of FDA’s regulatory science activities since 2007. His presentation highlighted a set of draft recommendations, which have since been finalized and will be presented in final form at the Science Board’s meeting this week.
The draft recommendations for continued FDA improvement in its science base mirror much of what FDA is already considering or engaged in. They’re also aligned with key elements of the two main policy vehicles coming down the pike in the near future: the House-passed 21st Century Cures bill, and potentially the key topics that may come up during PDUFA VI negotiations.
Key examples that I see here include improvements in areas such as:
- Biomarker qualification
- Clinical trial networks and master protocols
- Bayesian design
- FDA’s Sentinel Initiative
Philbert also highlighted broader recommendations, such as: working with the Reagan-Udall Foundation to leverage funding and resources; establishing merit awards and special pay levels for certain staff; and encouraging professional education to keep review staff “relevant and valuable” to the review function.
“We avoided being prescriptive” with the more aspirational elements of the progress report, he told the Science Board. The subcommittee “didn’t want to hogtie” the agency in case emerging needs dictate different priorities in the next few years.
This time around, we expect the final recommendations on Sept. 15 will lead to continued efforts to upgrade FDA’s science base. These improvements are important; however, with FDA science and mission no longer “at risk,” this phase may spur more of an evolution than a revolution in how FDA fulfills its mission.
The final report will be presented to the Science Board today. Later this week, Acting Commissioner Stephen Ostroff will also discuss the report during FDA’s annual Science Writer’s Symposium on Sept. 18. If you are a credentialed reporter, you may want to register for this event, to be held at White Oak.