Jean Hu-Primmer, acting director of FDA Medical Countermeasure Initiative Regulatory Science component, said that one of the goals of the workshop was to help identify anything else that might need to be added to the seven focus areas for Pillar 2 that FDA has defined (Box 6-1). One theme that stands out, she said, is the need for FDA to maintain the staff expertise to be able regulate new cutting-edge products. This is one of the key reasons why it is so important to maintain a robust science program inside FDA. “We strive to keep this program,” she said, “despite continued limited resources, downsizing, and budget cuts.” Professional development is critical, and it is important for FDA researchers to attend
BOX 6-1
Seven Regulatory Science Focus Areas of the FDA MCM Initative (Pillar 2)
- Animal models
- Biomarkers and clinical immunology
- Diagnostics and devices
- Private manufacturing and associated assay development
- Radiation injury protection and response
- Health and scientific computing
- Risk communication
the same scientific seminars and symposiums as academic and industry scientists, to learn about new methods and technologies, and to connect, network, and establish collaborations. Related to this is the need to work collaboratively across government agencies and to leverage those relationships.
While Pillar 2 is just “scraping the tip of the iceberg,” the MCM enterprise is moving in the right direction. The processes that have been set up for internal project proposal reviews, for example, engage all of the MCM enterprise partners. This peer-review process increases the visibility and awareness of partners, thereby creating greater potential for partnerships and collaboration with FDA and across the MCM enterprise as a whole.
The success of the FDA MCM initiative will not be dependent solely upon FDA’s efforts, Hu-Primmer concluded, explaining that it depends on everyone working together, from informal collaborations to competitive grants and contracts, and all options in between.
