The Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two" and sponsored by Senator Richard Burr (R-North Carolina), aims to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.
The Senate Health, Education, Labor, and Pensions Committee approved the bill, co-sponsored by Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), by voice vote, despite Democratic objections.
Several other proposals have contained, in part, similar provisions (or protections) as those found in the Biodefense and Pandemic Vaccine and Drug Development Act of 2005.[1]
The Bioshield Two bill would shift the main responsibility for developing bioterrorism countermeasures out of the Department of Homeland Security and into the new BARDA agency within the Department of Health and Human Services. The proposed new agency would improve on Project BioShield, a barely two-year-old program also meant to encourage the production of vaccines and drugs.
BARDA would receive a first-year budget of $1 billion. Other key aspects of the proposed legislation include:
Much of the support for the bill comes from Pharmaceutical Research and Manufacturers of America (PhRMA) and its members. In the 2002 election cycle, PhRMA contributed $3,505,052 to politicians, with 95% going to Republicans. The top recipient in the Senate was the bill's sponsor, Senator Richard Burr, who received $288,684, according to the non-partisan OpenSecrets.
Senator Burr said the legislation "creates a true partnership" between the federal government, the pharmaceutical industry and academia to "walk the drug companies through the Valley of Death" (referring to the period during which there are large capital expenditures for development but before profits, if any, can be realized) in bringing a new vaccine or drug to market.
Exemptions from open records and meetings laws would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill.[2]
Senator Chris Dodd (D-Connecticut) said "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."[3]