Optimize Legal, Regulatory and Policy Framework

Optimize Legal, Regulatory and Policy FrameworkModernize and optimize the legal, regulatory, and policy framework for efficient preparedness and response by assessing current laws and regulations and proposing changes that will facilite an efficient response to public health emergencies.

ON TRACK

1. Establish a legal and policy team (EPIC--Emergency Use Authorization (EUA) Policy Implementation Committee) to review and analyze current laws and regulations and recommend changes

12/31/2010

Completed

1/6/2011

2. Draft chapter on the medical countermeasures "FDA Emergency Preparedness and Response Roles and Authorities" for inclusion in a publication being issued by the Food and Drug Law Institute (FDLI), Food and Drug Law and Regulation Book

6/1/2011

Completed

6/13/2011

3. Propose to the Department changes to FDA's authorities to facilitate MCM availability as part of the Department's legislative package for reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). Revisions would allow FDA to issue EUAs in advance of a CBRN event, facilitate mass dispensing of approved products and authorize shelf-life extension.

6/30/2011

Completed

6/1/2011

4. Develop and issue doxycycline mass dispensing EUA

5/30/2012

Completed

7/21/2011

5. Develop and issue doxycycline USPS EUA for Cities Readiness Program

7/30/2012

Completed

10/14/2011

Additional milestones are currently under development.

http://www.fda.gov/AboutFDA/Transparency/track/ucm237964.htmFDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboardhttp://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htmMedical Countermeasures Initiative (MCMi)