Dec 15, 2006 (CIDRAP News) – Just before adjourning on Dec 9, the US Congress passed a bill to establish a new biodefense research and development agency and tune up the nation's public health emergency preparedness programs in a number of other ways.
The legislation sets up an agency called the Biodefense Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). The agency represents an attempt to revive the languishing Project BioShield, established in 2004 to develop countermeasures against biological weapons and other threats.
The legislation, called the Pandemic and All-Hazards Preparedness Act (S 3678), was passed by the Senate Dec 5 and cleared the House in the early morning hours of Dec 9. It now awaits President George W. Bush's signature.
"We're anticipating that he will sign it," Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness, told CIDRAP News today.
"I think people were surprised it made it through in the last hours there," Wolfson said. "There was a lot of negotiation that went into seeing it happen."
The final version combines a wide-ranging bill introduced in the Senate in July with a House measure calling for the BARDA. The House unanimously passed the BARDA bill, offered by Reps Anna G. Eshoo, D-Calif., and Mike Rogers, R-Mich., in September. The Senate added the house measure to its bill (S 3678) before passing it Dec 5; the House passed the combined bill just before adjournment.
Sen. Richard Burr, R-S.C., author of the original Senate bill, praised his colleagues of both political parties who worked for 2 years on the legislation. "This bill will help improve our preparedness and response to emergencies and disasters be they a terrorist attack or caused by Mother Nature," Burr said in a Dec 9 press release. "It will also help improve our ability to create new drugs and vaccines to fight against emergencies like a flu pandemic."
The bill reauthorizes the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, passed after the terrorist attacks of 2001. Besides setting up the BARDA, the legislation does the following, among other things:
- Clarifies that HHS, not the Department of Homeland Security, is the lead federal agency for health and medical response to public health emergencies
- Requires HHS to set general preparedness standards and pandemic influenza preparedness standards for states and to penalize states financially for failure to meet them
- Requires states to match federal preparedness grants at the 5% level initially and at 10% in later years
- Calls for establishing within 2 years a nationwide electronic information-sharing system to enhance detection of and response to disease outbreaks and other public health emergencies
- Requires HHS to study the possibility of providing local communities with additional medical surge capacity in an emergency
- Makes political subdivisions of states and groups of states eligible for federal assistance for public health preparedness
- Codifies and expands the Medical Reserve Corps, a community-based network of volunteers who provide assistance in public health emergencies
The BARDA aims to boost Project BioShield, which was set up to nurture the development of vaccines and other medical countermeasures against biological, chemical, radiological, and nuclear agents. Major pharmaceutical companies have shown little interest in pursuing BioShield projects.
An online report this week by Government Executive magazine said past efforts to create a BARDA were hamstrung by controversies about whether it would be subject to the Freedom of Information Act and other disclosure laws. Most provisions to circumvent those laws were stripped from the bill, except for one that allows HHS to withhold information that might expose public health weaknesses, the report said.
Eshoo, coauthor of the House version of the BARDA bill, said in a Dec 9 statement that the lack of commercial demand for drugs to counter bioterrorism-related diseases creates a funding gap known as the "valley of death." She said the BARDA will bridge the gap by making interim payments at key development milestones, which will give companies incentives to pursue products that show promise in early research.
HHS Secretary Mike Leavitt, in a Dec 5 statement after the Senate approved S 3678, said the legislation complements work that is already being done to improve the BioShield program. He said HHS is taking steps to streamline countermeasure development by making the process more transparent and predictable. The new legislation will allow HHS to make milestone-based advance payments to companies, rather than withholding payment until the product is delivered, Leavitt said.
The text of the bill says that the HHS secretary can pay up to 10% of a contract amount in advance if it appears necessary to ensure the project's success. Also, a contract can provide for additional advance payments of up to 5% each for meeting milestones specified in the contract, up to a total of 50%.
Lance Ignon, vice president of corporate affairs at VaxGen Inc., a Brisbane, Calif., company that has been struggling to fulfill an $877.5 million government contract to supply anthrax vaccine, told CIDRAP News that the legislation is a step in the right direction. "But what's needed is a fundamental cultural shift to a more open and transparent dialogue between government and industry," he said. "Unless that happens, this won't succeed."
VaxGen's anthrax vaccine has been delayed because of potency problems, and in May, the Government Accountability Office said the government's contract with VaxGen was too rigid and might discourage other biotechnology companies from pursuing Project BioShield contracts. Developing new vaccines is expensive, difficult, and often hampered by testing and production delays.
"Getting across the valley of death is not necessarily about money, but involves a true partnership between government and industry," Ignon said.
The new legislation authorizes spending of $1.07 billion for BARDA for fiscal years 2006 through 2008.
In an August report, the Congressional Budget Office estimated that the original Senate bill—which did not include the BARDA provision—would cost $297 million in fiscal year 2007 and about $6 billion for the period 2007 through 2011.
Government Printing Office text of bill
Dec 9 press release from Sen. Richard Burr
Dec 9 statement from Rep. Anna Eshoo
Dec 5 HHS press release
Jul 19 story CIDRAP News story "Broad health preparedness bill advances in Senate"