BARDA Funding Requirements

In 2008, the Center performed the first economic analysis of the cost and probability of success of the U.S. government’s civilian biodefense medical countermeasure (MCM) pipeline for FY 2009. (See Cost/Success Projections for U.S. Biodefense Countermeasure Development).

The MCM pipeline is managed by the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). Our analysis demonstrated that the funds allocated by Congress would not support BARDA in meeting the requirements of the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Implementation Plan, in which HHS defined a series of requirements for MCMs deemed essential to protect civilians against biological threats. (Read the original analysis.)

We have updated this analysis for FY 2010, and our results this year lead to the same conclusion: funding for BARDA (still) does not support the agency’s mandate (see updated analysis, below).

We also recently fielded a critique published as a letter to the editor of Nature Biotechnology, where our analysis originally was published. While this critique focused on our methodology, which we stand solidly behind, the letter’s authors found essentially the same results as we did, thus confirming our conclusion that BARDA’s MCM pipeline is significantly underfunded. (Read our response.)
                   

                        
BARDA FY10 Advanced Development Cost Estimates for Medical Countermeasures Against Biological Threats 

(updated July 7, 2009)  

• This analysis addresses only PHEMCE requirements for MCMs against biological threats. It does not include MCM requirements for radiological, nuclear, or chemical weapons, nor does it include diagnostics, biodosimetry tests, or CHEMPACKS. BARDA is responsible for all of these products.
• These estimates include ONLY advanced development costs, which do not include the costs of basic research, pre-clinical development, manufacturing, stockpiling, or maintaining these MCMs.
• Sustained funding (over many years) is necessary to successfully develop any MCMs, given the long timelines of biopharmaceutical development.

The number of MCMs currently in development yields a low probability of success

One option for the country would be to budget advanced development funding for only those candidate MCMs currently in development. Based on our survey, 1 year of BARDA advanced development funding for MCMs in development would cost $1,053M in FY10.

However, biopharmaceutical development has very high failure rates. For every 5 small molecule drugs or 3 three biological therapeutics that enter advanced development, only 1 is ultimately granted FDA approval. Therefore, $1,053M of funding for the candidate MCMs currently in development would produce the following probabilities of success:

 
A substantial increase in BARDA funding is needed to increase the probability of success

If its current level of funding—$275M—is continued annually, BARDA will be able to support only the 7 most mature MCM candidates in the pipeline. It will have no funding left for the 25 remaining candidates. Moreover, based on historical failure rates of drug development, it is likely that only 2 of those 7 candidates will ultimately receive FDA approval.

To have at least a 90% probability of developing 1 successful product for each PHEMCE biological threat requirement, the portfolio of candidate MCMs must be expanded. One year of BARDA advanced development funding for this larger MCM portfolio would be $3,714M in FY10.

[Note: This updates the Center for Biosecurity’s FY09 BARDA cost analysis with a new MCM candidate pipeline survey. Methodology is from: Matheny, J., M. Mair, and B. Smith, (2008) “Cost/Success Projections for US Biodefense Countermeasure Development,” Nature Biotechnology, 26:981-983.]