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U.S. Department of Health and Human Services

Product Transitions

The transition of candidate or approved products across the PHEMCE partners is a key indicator of success of the PHEMCE. Coordination among the partners is central to efficient use of funding for this purpose. The MYB provides a long-range forecast of when products may be available for transition to the next stage (i.e., to the next PHEMCE partner or the next source of funding) for development or procurement. It may also inform decision-making concerning PHEMCE activities such as the SNS Annual Review.

During FYs 2018–2022, BARDA anticipates seven MCM product transitions from Project BioShield to SNS. Transitioning these products will increase the need for funding in the SNS budget to support replenishment of expiring MCMs. Replenishment costs arise from products purchased previously by BARDA or SNS that expire and need to be restocked. A total of $1.1 billion is estimated to support replenishment of MCMs by SNS. This report also removes the transition of the botulinum countermeasure, hBAT, from Table 3. The previous report included the best available estimate for regenerating the hyperimmune horse herd that provides the antibodies for the hBAT product. The existing supply and production capacity for the hBAT product is sufficient to meet the current PHEMCE requirement for the next 10 years. Progress toward regulatory approval for two additional products has accelerated their planned transition and they are added to the table under Radiological or Nuclear (Rad/Nuc) MCMs. Table 3 details the products expected to transition from PBS to SNS and the associated two-year replenishment costs.


Table 3. Estimated SNS Spending Needed for MCM Product Replenishment of Products Anticipated to Achieve FDA Approval Previously Procured by BARDA under Project BioShield, FYs 2018–2022

Medical Countermeasure Estimated
Transition
Timeframe (FY)
Estimated Cost
FY 2020-2021
(dollars in millions)
 Anthrax Therapeutic 2021 $287.0
 Anthrax Therapeutic 2021 $153.9
​Anthrax Therapeutic​2020​TBD5
​Chemical Anticonvulsant​2021$​41.6
​Rad/Nuc Thermal Burn2020​$12.0
​Rad/Nuc Antineutropenic​2021​$134.0
​Smallpox Vaccine​2022​$196.0
​Small Antiviral​2020​$253.1


 


5 Cost estimate pending policy review of anthrax antitoxin stockpiling requirements.


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  • This page last reviewed: January 29, 2020