Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Emergency Preparedness and Response

  • Print
  • Share
  • E-mail
-

Pillar I: Enhance MCM Regulatory Review Process

The Pillar 1 mission is to enhance the product review process for medical countermeasures (MCMs).  To fulfill this mission, FDA is establishing Public Health and Security Action Teams (Action Teams) comprising 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

 
FDA is establishing MCMi Action Teams based on priorities identified in collaboration with the Public Health Emergency Medical Countermeasure Enterprise. The Action Teams are in alignment with other Federal investments in medical countermeasure programs:
 
  • Action Team on Multiplex In Vitro Diagnostic Tests:  This Action Team will identify and help 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: Acute radiation syndrome 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: This Action Team will be working to address issues associated with developing radiation diagnostics for biodosimetry, which are a high-priority for an effective response to a radiological or nuclear event.
  • Warfighter/Trauma Action Team: This Action Team will focus 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: This Action Team will tackle 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: This 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 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)
 
FDA has also scheduled and held a series of briefings by relevant experts to ensure that all FDA reviewers are fully aware of the public health threats (and therefore the risks) the nation faces as they conduct risk–benefit analyses on MCM products.
 
-
-