FDA Takes Steps To Spur Development Of Medical Countermeasures To Prepare For Emerging Threats To Public Health And National Security

Biologics, drugs and devices – that can be used to diagnose, prevent, protect from, or treat conditions associated with chemical, biological, radiological, or nuclear threats, including emerging infectious diseases…

Last month, the U.S. Food and Drug Administration issued draft guidance, Material Threat Medical Countermeasure Priority Review Vouchers, which explains how the agency is implementing the priority review voucher or PRV program to incentivize the development of certain drug and biologic medical countermeasures (MCMs).

MCMs are FDA-regulated medical products – including biologics, drugs and devices – that can be used to diagnose, prevent, protect from, or treat conditions associated with chemical, biological, radiological, or nuclear threats, including emerging infectious diseases.

The material threat MCM PRV program aims to encourage the development of material threat MCMs by awarding priority review vouchers to product developers that receive the FDA’s approval for certain MCMs to address material threats to national security. These material threats are determined by the Secretary of the U.S. Department of Homeland Security.

The PRV can be used by a product developer on any subsequent FDA application, enabling the company using the PRV to potentially bring a product that otherwise would not qualify for priority review to market up to 4 months sooner than under standard review.

Established under the 21st Century Cures Act, the Material Threat MCM program is the third PRV program to be established, along with PRV programs to incentivize development of treatments for certain tropical diseases and rare pediatric diseases. The FDA is accepting comments on the draft guidance for 60 days.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

With the wider availability of scientific tools that can be used to craft deliberate threats to public health, along with a rising natural incidence of new and deadly pathogens; we need to find more ways to create incentives for the development of countermeasures to thwart these emerging threats,” said FDA Commissioner Scott Gottlieb, M.D. “We know there can be economic and other challenges to developing and manufacturing these kinds of products during and in advance of public health emergencies. We saw this most recently as the scientific and medical product community worked to address both the Zika and Ebola outbreaks, where effective treatments didn’t already exist. To address these dangers, the FDA is taking steps to quickly and effectively implement the new medical countermeasure priority review voucher program, which aims to incentivize the development of products that can better prepare our nation to respond to emergencies.”