As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.
With a budget of a little more than $110 million, FDA’s MCM efforts play a critical role in protecting the US from dangerous threats and emerging infectious disease threats, such as pandemic influenza, Ebola virus disease and Zika virus infections. The agency is responsible for assessing the safety and effectiveness of MCMs —including drugs, therapeutic biologics, vaccines and devices, such as diagnostic tests—to counter these threats.
"FDA continues to respond to emerging public health threats in an unprecedented way. The tragic Ebola epidemic in West Africa was declared over in early 2016, and the World Health Organization (WHO) declared in November 2016 that Zika is no longer an international public health emergency," Luciana Borio, MD, FDA's acting chief scientist, said in a statement. "However, this doesn’t mean that these diseases are no longer a concern. Vaccines for Ebola are still under development. WHO has identified—and the global public health community agrees—that Zika is a serious public health issue that will require sustained and long-term efforts moving forward. We must continue to expedite development of MCMs to detect, treat, and prevent emerging diseases—particularly Zika, which is likely to become endemic in much of North America, with devastating and life-altering consequences for some of our most vulnerable populations."
As a means of encouraging further MCM development, the new 21st Century Cures law also creates a new priority review voucher program for MCM sponsors.
In the area of MCMs to treat diseases or conditions caused by CBRN threats, FDA approved the monoclonal antibody Anthim (obiltoxaximab) to treat inhalational anthrax in combination with appropriate antibacterial drugs. FDA also expanded the indication for BioThrax (Anthrax Vaccine Adsorbed) to include post-exposure prophylaxis (PEP) of disease resulting from suspected or confirmed B. anthracis exposure.
For pandemic influenza preparedness, FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. FDA also approved five new nucleic acid-based influenza tests: three qualitative in vitro diagnostic (IVD) tests for the detection and differentiation of influenza A, influenza B and respiratory syncytial viruses (ARIES Flu A/B & RSV Assay, Cobas Influenza A/B & RSV, and Xpert Flu+RSV); a qualitative IVD test for the detection and differentiation of influenza A and B viral RNA (Solana Influenza A+B Assay); and a multiplexed device for the qualitative detection of influenza A (with sub-type differentiation), influenza B, and other respiratory viruses and bacteria (NxTag Respiratory Pathogen Panel).
On the hazard preparedness front, FDA approved the Ahead 300 device, which analyzes a patient’s electroencephalograph using a sensor attached to a smartphone to provide an interpretation of the structural condition of the patient’s brain after a head injury at the point of care.
In the area of diagnostics for CBRN threats, FDA approved a Shiga Toxin Direct Test for the detection of nucleic acids and toxin gene sequences found in Shiga toxin producing strains of E. coli 0157 and Shigella dysenteriae, in stool specimens. And for re-emerging threats, FDA approved three modifications to a Bordetella pertussis assay.
In FY 2016, FDA continued to implement its MCMi Regulatory Science Program with collaborative research and partnerships with government agencies, academia and industry. Examples of progress include:
- Developing models of radiation damage in lung, gut, and bone marrow organs-on-chips and then using these models to test candidate MCMs to treat such damage
- Developing diagnostics that can detect botulism neurotoxin at low levels in food
- Evaluating the use of chimeric viruses to improve production of influenza B vaccines.
MCMi Fiscal Year 2016 Program Update