Emergency Response Measures
This article was originally published in SRA
Executive Summary
US bill proposes creation of biomedical R&D agency
US bill proposes creation of biomedical R&D agency
The US House of Representatives has passed and sent to the Senate a bipartisan bill that would establish the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services (HHS).
The legislation, the Biodefense and Pandemic Vaccine and Drug Development Act of 2006, would establish BARDA as a central authority for the advanced research and development of medical countermeasures, such as drugs and vaccines, in response to bioterrorism and natural disease outbreaks1,2. The bill earmarks $160 million for the agency for each of the fiscal years 2007 and 2008. In addition, the bill's sponsor, Representative Mike Rogers (Republican - Michigan) says it will motivate academic researchers, drug and vaccine manufacturers and other possible partners to accelerate the development of medical countermeasures and bring new and improved products to the market quickly. To support innovation, the HHS would have the authority to award contracts, grants, co-operative agreements and prize payments to eligible US and foreign nationals.
Mike Leavitt, the HHS secretary, said that the bill complements the work of the BioShield programme as “it supports much needed late-stage research and development funding, and will allow us to make milestone-based advance payments under BioShield”3. Project BioShield was signed into law by President Bush on 21 July 2004 to improve medical countermeasures against a chemical, biological, radiological or nuclear attack4.
Mr Leavitt added that he looked forward to working with Congress to resolve any remaining issues and clear the way for final passing of the bill this year.
A companion bill was introduced in the Senate on 6 April 2006, sponsored by Senator Richard Burr (Republican - North Carolina). It has been referred to the Senate committee on Health, Education, Labor and Pensions5.
References
1. H.R. 5533 Biodefense and Pandemic Vaccine and Drug Development Act of 2006, 27 September 2006, http://thomas.loc.gov
2. Congressman Mike Rogers press release, 21 September 2006, www.mikerogers.house.gov/newsroom.aspx?A=259
3. HHS press release, 27 September 2006, www.hhs.gov/news/press/2006pres/20060927.html
4. The White House, Policies in focus, accessed 3 October 2006, www.whitehouse.gov/infocus/bioshield
5. The Regulatory Affairs Journal - Pharma, 2006, 17(5), 336-337