The United States Senate on May 19, 2004 approved legislation authorizing Project Bioshield, a program President Bush first outlined during his 2003 State of the Union address to prepare the nation better against a biological attack. The House is expected to approve the Senate passed legislation, and the President will sign the bill into law shortly.
Purpose of the Law
Congress identified a need to create incentives for companies to invest in research, development, and production of biological countermeasures. Because of the lack of commercial applications for such drugs e.g., vaccines against anthrax, most companies have very little business reason to invest in the biological countermeasure market. Accordingly this has left the nation with fewer countermeasures to treat diseases caused by biological agents. Further, Congress found that where developmental drugs exists, there is no mechanism to allow for the use of such a product where the Food and Drug Administration (FDA) has not granted prior approval. This compounds the supply problem and leaves the nation in a precarious situation where there may not be a sufficient supply of a needed treatment to administer to exposed victims of a biological attack.
Expanded Authority Granted To The Secretary of Health and Human Services (HHS)
Significant new authority is granted to HHS under the legislation in the areas of promoting research and development of new countermeasures, the drug approval process, and the stockpiling of needed countermeasures to ensure an adequate supply of needed drugs for certain identified pathogens.
Promoting Research and Development:
Project Bioshield encourages research, development, and production of new biological countermeasures through a number of changes to current law. HHS (working through the National Institutes of Health (NIH)) is given authority to waive current peer review procedures in the awarding of direct grants under $1.5 million dollars, and can "fast track" peer review in circumstances where the funding exceeds $1.5 million. This allows far greater flexibility and discretion than previously afforded in the awarding of contracts to private businesses. Additionally, the legislation provides authority to hire experts and consultants to meet research and development needs in the creation of biological countermeasures.
Drug Approval Process:
Project Bioshield gives HHS the authority to declare an emergency allowing the use of drugs that have not received FDA approval. Under this provision, unapproved drugs, medical devices, and other biological products that are not FDA approved may be distributed while the declaration is in place.
Procurement of Biological Countermeasures:
Project Bioshield authorizes $5.6 billion for a special reserve fund to maintain a sufficient national stockpile of biological countermeasures against certain threat pathogens. The law allows for a single agreement between HHS and a contracting entity that provides for research, development, and procurement. This is intended to encourage private companies to invest in drugs for the biological countermeasure market created by the government
Conclusion
HHS has been preparing to implement this new program since last year. This law is the federal government’s response to both a pressing national concern and the biomedical industry’s complaint of lack of incentives to enter into the biological countermeasure market. The discretion afforded to HHS will expedite the government grant and procurement process with respect to the development of these drugs, and creates a very favorable opportunity for those seeking government support for federally sponsored research and development programs.
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