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), aims to shortcut safety testing 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.

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 production of vaccines and drugs.

BARDA would receive a first-year budget of $1 billion. Other key aspects of the proposed legislation include:


 * 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, distibutors, 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.
 * Extension of some prescription drug patents.
 * Allow the Department of Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product.
 * Forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures.
 * Exempt countermeasures from certain federal cost oversight requirements.

Support
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 Center for Responsive Politics.

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" 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
The bill is opposed by those who believe the act does nothing to address the perceived threat of a deadly avian flu epidemic in the near-term, and that the bill's market exclusivity provisions would unnecessarily drive up prescription drug costs and further erode the already limited range of legal recourse for vaccine injury victims. Company liability protections should only apply when a product is used in an emergency, and not for other situations, according to critics of the bill.

Some scientists have expressed concern the new agency could draw funds away from the federal Centers for Disease Control (CDC) and the National Institutes of Health (NIH), and disrupt their work. The Federation of American Societies for Experimental Biology told Burr it was "troubled over the impact this new agency might have on existing programs at the National Institutes of Health and the Centers for Disease Control and Prevention, particularly in an era of limited funding for discretionary spending."

Opponents are also skeptical of the act because of what they see as the dismal history of injury and poor efficacy of vaccines and anti-viral drugs, and because the proposed act specifically exempts BARDA from the Freedom of Information Act.

The National Vaccine Information Center (NVIC) denounced the bill as "a drug company stockholder's dream and a consumer's worst nightmare." According to NVIC, there are currently at least ten different bills pending in Congress containing provisions to shield drug companies from lawsuits including S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245.

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."

"The damage already done to our society is already in the trillions of dollars," warns controversial autism researcher Mark Geier, who believes that this may be the greatest iatrogenic epidemic in history, adding "The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism," he told Veritas.