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U.S. Department of Health and Human Services

Conclusion

This report represents HHS’s current estimates for the basic research, advanced research and development, regulatory review, procurement, stockpiling, and replenishment of the U.S. government’s civilian medical countermeasure enterprise. ASPR developed this budget forecast without regard to the competing priorities that the Secretary, other HHS officials, and the President must consider when developing the annual President’s Budget request.

The PHEMCE continues to successfully deliver MCM products to the SNS that mitigate the risk presented by the most important threats to the nation. It does so with a continuous focus on being effective stewards of the resources that Congress appropriated toward these efforts. Since its inception, the PHEMCE targeted resources to high-priority threats and as a result has a ready stockpile of MCMs against anthrax, smallpox, botulinum, and pandemic influenza. In recent years, the PHEMCE expanded its capabilities by developing, licensing, and procuring MCMs against chemical, radiological, and nuclear threats. Additionally, PHEMCE prioritizes the needs of special or vulnerable populations, such as children, pregnant women, and immunocompromised individuals, in the development of products and technologies.

The PHEMCE also maintains its commitment to progress by improving MCM response capabilities and identifying the need for a 14 percent increase in total forecasted funding relative to the FYs 2017–2021 Report. For several years, the PHEMCE has faced difficult decisions regarding prioritizing research and development efforts, and sustaining domestic manufacturing and other capacity, as well as the SNS formulary. This effort has become more challenging over time due to the number of existing MCM requirements, Project BioShield and other products successfully achieving approval, and the emergence of new threats, while the purchasing power has not increased correspondingly. Plans for completing the 2017 SNS Annual Review (FY 2020 Plan) are under review.

The PHEMCE faces the challenge of maintaining a stockpile of MCMs against a plethora of low-probability, high-consequence threats, while continuing to develop important countermeasures against other threats, and maintaining the capacity to rapidly respond to novel threats like emerging or re-emerging infectious diseases. To stretch the taxpayer dollar further, the PHEMCE is examining new mechanisms for reducing development and stockpiling costs. These include new public-private partnerships to reduce development costs, vendor-managed inventory of commercially available drugs to reduce replenishment costs, and the development of next-generation MCMs.

 

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  • This page last reviewed: January 29, 2020