The U.S. Food and Drug Administration (FDA) released its medical countermeasures initiative (MCMi) fiscal year 2015 update on Thursday as required by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.
The FDA laughed the MCMi in 2010, building on the substantive medical countermeasure (MCM) work at the FDA and focusing increased resources on promoting the development of MCMs by establishing clear regulatory pathways for MCMs, instituting effective regulatory policies to facilitate time access to MCMs, and advancing MCM regulatory science to create tools that support regulatory decision-making.
The FDA obligated $129.7 million in FY 2015 to support chemical, biological, radiological and nuclear (CBRN) and pandemic influenza-related medical countermeasure activities, according to the report. Additionally, the FDA allocated $112.3 million in base resources to support CBRN and pandemic influenza-related MCM activities, including $52 million for CBRN preparedness activities, $35.7 million for pandemic influenza activities and $24.6 million for the MCMi. The funding supported 467.5 full-time equivalents (FTEs), as well as a $1.6 million investment in the MCMi regulatory science program.
The FDA also received $25 million in emergency supplemental, no-year funding to support activities related to responding to the Ebola epidemic in West Africa, including conducting medical product review and funding regulatory science research to help expedite the development and availability of medical products for Ebola.