FDA progress report: Medical responses to public health emergencies

Last summer, FDA announced an action plan for medical countermeasures, such as drugs, vaccines, and diagnostic tests, to be used in responding to a public health emergency.

The part of that effort aimed at regulatory science for medical countermeasures has been getting off the ground in recent months, FDA said in an August 19 presentation, with 85 intramural research projects in different parts of the agency on topics such as “accelerated methods to screen drugs at point of entry or distribution to verify identity and quality” and methods to assess novel adjuvants’ added value to pandemic influenza response.

Another project is looking at a web/smart phone-based, real-time active surveillance for medical countermeasures and pharmacovigilance in a pandemic or chemical, biologic, radiologic or nuclear emergency, according to Jean Hu-Primmer, MS, senior regulatory advisor in Office of Counterterrorism and Emerging Threats, who spoke at a Science Board Meeting at the agency’s main campus outside Washington, D.C.

FDA is also holding a meeting October 13 and is calling for comment on “highly multiplexed devices for the diagnosis of infectious diseases,” which the agency says is a new generation of products designed to simultaneously identify and differentiate many pathogens from one specimen.

The research topics under the medical countermeasures effort include among others development of animal models; biomarkers; immunology; quality measures; protection against radiation injury; in vitro diagnostics; health informatics; and emergency medical equipment.

For more information, go to http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm and to http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm241888.htm.