FDA Medical Countermeasures Initiative Update

National Preparedness Month

FDA and Access to Medical Countermeasures During Public Health Emergencies

Hurricane Dennis batters palm trees and floods parts of Naval Air Station (NAS) Key West’s Truman Annex

by Brooke Courtney, JD, MPH
Just weeks after witnessing the fall of the World Trade Center on Sept. 11, 2001, I was a student volunteer in a New York City hospital emergency department when several people arrived saying they had been exposed to anthrax. (continues...)

That year, 2001, was a turning point in our nation’s readiness for public health emergencies, including those that result from deliberate attacks or from natural causes like a disease outbreak. In particular, the U.S. government has invested substantially in medical products required for diagnosis, prevention or treatment of a wide range of threats, including anthrax. FDA is part of that national preparedness.
September is National Preparedness Month. And while FDA and other agencies work hard every day to help prepare the nation for potential threats, everyone can be involved in disaster readiness.
read the full post

Related information

Preparedness information for consumers
Hurricane safety checklist (food, water and medical product safety)
MCM-related counterterrorism legislation
Public Health Emergency Medical Countermeasures Enterprise

Image: Key West, Fla. (July 9, 2005) – Hurricane Dennis batters palm trees and floods parts of Naval Air Station Key West’s Truman Annex. The storm passed within 125 miles of the base, clocking winds in excess of 90 miles an hour and dumping more than seven inches of rain before moving north through the Gulf of Mexico. Atlantic hurricane season began June 1 and ends Nov. 30. U.S. Navy photo by Jim Brooks

Memo to state and local public health and first responder stakeholders

On September 15, 2015, FDA issued a memo (PDF, 28 KB) to state and local public health and first responder stakeholders about expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles. Related: doxycycline and penicillin G procaine for inhalational anthrax (post-exposure)

News updates

Events:

October 7, 2015: HHS Public Forum on Developing Rapid Diagnostics to Combat Antibiotic-Resistant Bacteria (San Diego, CA) - provide input on the types of diagnostics that may be developed to combat the growth and spread of antibiotic resistant bacteria

October 14-16, 2015: BARDA Industry Day (Washington, DC)

October 16, 2015: Public workshop - Non-Microbial Biomarkers of Infection for In VitroDiagnostic Device Use (Silver Spring, MD and webcast) - The purpose of this workshop is to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Register by October 6, 2015.

November 12, 2015: Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests - register by October 30, 2015 - related blog post

November 13, 2015: Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants - register by October 30, 2015

View more events on the frequently updated MCMi News and Events page

Preparedness and response:

HHS/ASPR project - Mass decontamination research provides new scientific evidence for responders, hospitals to decontaminate chemical terrorism, accident survivors (September 22, 2015)

Ebola:

HHS advances development of new monoclonal antibody drug for Ebola (September 21, 2015)

Experimental Ebola vaccine regimen takes new steps under HHS program (September 14, 2015)

View FDA Ebola response updates by date

Antimicrobial resistance:

HHS enters into strategic alliance to accelerate new antibiotic development - partnership stimulates pipeline of drugs to treat multi-drug resistant bacterial infections (September 16, 2015)

Federally funded research:

Biomarkers for Brain Injury Monitoring - Recent advances in flexible microelectronics that are wearable and conformable to the skin bring us closer to a future where portable electroencephalogram (EEG) technology could be used to detect brain injury in victims of traumatic events such as accidents or explosions.To evaluate this new technology for use in humans, FDA needs a scientific knowledge base related to validated brain injury biomarkers and models. This research could help pave the way for the development of field-deployable devices that can rapidly collect and evaluate EEG signals to diagnose traumatic brain injury. Read more in this MCMi Regulatory Science Profile

HHS advances development of novel drug to treat influenza (monoclonal antibody therapeutic) (September 29, 2015) and sponsors development of drug for hospitalized influenza patients (September 28, 2015)

HHS explores new disaster use of approved ‘clot busting’ drug - Drug shows promise as potential lifesaver in mustard gas attack (September 23, 2015)

Guidance:

Reminder - deadlines to submit comments:

Draft guidance - Rare Diseases: Common Issues in Drug Development (PDF, 306 KB) - comment by October 16, 2015

Draft guidance - Nonproprietary Naming of Biological Products (PDF, 111 KB) comment byOctober 27, 2015

Proposed rule: Designation of Official Names and Proper Names for Certain Biological Products - submit comments by November 12, 2015

Proposed rule - Federal Policy for the Protection of Human Subjects - comment byDecember 7, 2015

How to submit comments

More deadline reminders:

The NIAID/NIH Centers for Medical Countermeasures Against Radiation (CMCR) is nowaccepting letters of intent (due October 9, 2015) for pilot projects focused on practical approaches for radiation biodosimetry or the development of agents for the mitigation of acute or late radiation effects.

NIH and CDC are soliciting proposals from small businesses to conduct research and development, including possible medical countermeasure-related research - respond byOctober 16, 2015.

FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects

In case you missed it:

FDA Announces First-ever Patient Engagement Advisory Committee (September 18, 2015)

New England Journal of Medicine Perspective - Combating Emerging Threats — Accelerating the Availability of Medical Therapies , by FDA's Luciana Borio, MD, Edward Cox, MD, MPH, and HHS ASPR Nicole Lurie, MD, MSPH