Emergency Preparedness and Response
Pillar I: Enhance MCM Regulatory Review Process
What We Do
Pillar 1 enhances the product review process for medical countermeasures (MCMs). To this end, FDA has established Public Health and Security Action Teams (Action Teams) of subject matter experts who can review MCM developmental pipelines and help identify potential gaps in regulatory, scientific, or policy areas that may be delaying MCM approvals.
The Action Teams are working with internal and external experts to identify challenges and hurdles to navigating the MCM development pathway. Action Teams are fostering MCM development more generally by facilitating the use of consistent regulatory approaches and helping identify and implement best regulatory review practices across FDA’s medical product centers.
Pillar 1 Highlights
- Action Team on Multiplex In Vitro Diagnostic Tests identifies and helps resolve potential scientific, legal, regulatory, and policy gaps that may be inhibiting the development of multiplex in vitro diagnostic tests. Such diagnostics could be used to test for multiple pathogens simultaneously, providing invaluable information when responding to a public health emergency.
- Action Team on Acute Radiation Syndrome (radiation sickness) raises a variety of issues that might result from a potentially lethal exposure to radiation as would be expected to occur after a radiological or nuclear event. This Action Team is supporting the development and approval/licensure of candidate MCMs to treat acute radiation syndrome.
- Radiological/Nuclear Event Dosimetry Action Team addresses issues associated with developing radiation diagnostics for biodosimetry, which are a high-priority for an effective response to a radiological or nuclear event.
- Warfighter Action Team focuses primarily on the needs of the warfighter and the variety of products that may be needed to support their efforts.
- Action Team on Pediatrics and Pregnancy tackles issues associated with effective use of stockpiled MCMs and the identification of specific needs, opportunities, or challenges related to development of or availability of MCMs for these at-risk populations.
- MCMi Surveillance Action Team, established in May 2012, is a collaboration between FDA and the Centers for Disease Control and Prevention. The goal is to facilitate and support a coordinated strategic plan for developing, implementing, and using surveillance equipment and related systems to monitor the safety and/or performance of MCMs during a public health emergency.
Collaboration is Key
Collaboration with all related stakeholders is critical to the success of the nation’s MCM efforts. FDA has held and is planning a number of public workshops to obtain scientific and public input on MCM-related issues:
- Complex in vitro diagnostic tests (September 2011)
- Development and evaluation of next-generation smallpox vaccines (September 2011)
- Using scientific data to support pediatric medical device claims (December 2011)
- An Advisory Committee meeting on smallpox drugs (December 2011)
- MCMs for pediatric populations (winter 2012)