# Biodefense and Pandemic Vaccine and Drug Development Act of 2005

The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S. 1873), nicknamed "Bioshield Two" and sponsored by Senator Richard Burr (R-North Carolina), aimed 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. A key provision of the proposed bill was the establishment of a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would serve as the central authority to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks. The bill also proposed shielding the agency from public Freedom of Information Act (FOIA) requests, which would protect it from long-standing open records and meetings laws.
The bill, co-sponsored by Bill Frist (R-TN), Mike Enzi (R-WY), Judd Gregg (R-NH), and Lamar Alexander (R-TN), was approved by the Senate Health, Education, Labor, and Pensions Committee through voice vote. However, it faced opposition from Democrats who raised concerns about transparency, accountability, and national security. Ultimately, the bill did not pass in its original form. However, many of its provisions were later incorporated into the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, and later, the Pandemic and All-Hazards Preparedness Act of 2006.

## Key provisions

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 included:
* Provision of rebates or grants as incentives for domestic manufacturing of vaccines and medical countermeasures against bioterrorism and natural disease outbreaks.
* Liability protections for drug makers that develop vaccines for biological weapons. The measure would make manufacturers, distributors, health care providers, or administrators of security countermeasures immune from liability caused by a security countermeasure or any pandemic/epidemic product, by means of a limited antitrust exemption.
* Establishment of a single agency, the Biomedical Advanced Research and Development Agency, as the lead federal agency for the development of countermeasures against bioterrorism. The new agency would report directly to the Secretary of Health and Human Services, which would have sole authority to decide whether a manufacturer violated laws mandating drug safety. Citizens would be banned from challenging such decisions in the civil court system. The agency would 'partner' with drug makers while placing information about such partnerships outside of public view.
* BARDA was designed to streamline the development of vaccines, drugs, and medical countermeasures by reducing bureaucratic hurdles and accelerating research and approval processes.
* The agency aimed to foster collaborations between the government and pharmaceutical companies, offering funding and support for vaccine and drug development while ensuring that intellectual property rights remained protected.
* One of BARDA's responsibilities would be to increase national stockpiles of vaccines, antiviral drugs, and essential medical supplies to prepare for bioterrorist threats or emerging infectious diseases.
* The legislation encouraged investment in cutting-edge research, such as next-generation vaccines and medical technologies, to improve responses to pandemics and bioterror threats.

## Support

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.

## Opposition

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."