Project BioShield - Project BioShield Act of 2004

[Guest LAW_*]

On July 21, 2004, the President of the United States, George W. Bush, signed the Project BioShield Act of 2004 (Project BioShield) into law (Public Law 108-276) as part of a broader strategy to defend America against weapons of mass destruction. The purpose of Project BioShield is to accelerate the research, development, purchase and availability of medical countermeasures including therapeutics, vaccines, medical devices and diagnostics to protect Americans against the effects of chemical, biological, radiological, and nuclear (CBRN) agents.

 

In Project BioShield, Congress gave the Secretary of the U.S. Department of Health and Human Services (HHS) enhanced authorities to develop and acquire these medical countermeasures. The measure supports the recovery and response pillar of the President's Biodefense for the 21st Century, a comprehensive blueprint for America's biodefense. The new HHS authorities include the following:

 

*

 

Use of certain procedures regarding research and development activities that involve qualified medical countermeasures. These authorities are found in Section 2 of the Project BioShield Act and insert a new section (319F-1) in the Public Health Service Act. The added section authorizes the use of a variety of streamlined procedures in awarding grants, contracts and cooperative agreements relating to the research and development of qualified countermeasures. The streamlined procedures include: (1) expedited peer review to assess the scientific and technical merit of research proposals up to $1.5 million; (2) an increase of the simplified acquisition threshold from $100,000 to $25 million; (3) an expedited limited competition process in some circumstances; and (4) an increase in the micropurchase threshold from $2,500 to $15,000.

*

 

Authority to use the Special Reserve Fund (SRF) for the acquisition of medical countermeasures for the Strategic National Stockpile. This authority is in Section 3 of the Project BioShield Act. The SRF, provided in the Department of Homeland Security Appropriations Act (P.L. 108-90) on October 1, 2003, makes available $5.593 billion over 10 years (FY04 to FY13) for the advanced development and purchase of priority medical countermeasures for the Strategic National Stockpile (SNS). Of that amount, $3.4 billion may be obligated during FY04 to FY08.

*

 

Additional Authorities Regarding the Procurement of Security Countermeasures. These procurement authorities are found in Section 3 of the Project BioShield Act and add Section 319F-2 of the Public Health Service Act. This section authorizes the use of a number of streamlined contracting procedures for the procurement of security countermeasures. The streamlining includes the use of simplified acquisition procedures if the Secretary determines a pressing need for a security countermeasure procurement. The procedures also provide for a limited competition process in some circumstances, as well as the ability to pay premiums in multiple award contracts to vendors based on the priority of the production and delivery of an increment of the security countermeasure.

*

 

Emergency Use Authorization (EUA) for medical countermeasures. This authority is in Section 4 of the Project BioShield Act and adds Section 564 of the Federal Food, Drug, and Cosmetic Act. This section permits the HHS Secretary to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use in an actual or potential emergency, even if the product is not approved, cleared, or licensed by the HHS/Food and Drug Administration (FDA) within HHS or is approved, cleared, or licensed for a different use. The Secretary has delegated this authority to the HHS/FDA Commissioner. The FDA Commissioner may invoke this authority only following a declaration of emergency by the Secretary. The Secretary may issue such a declaration based on a determination of a public health emergency that affects or has the significant potential to affect national security and involves a specific threat agent, or on the basis of an attack, or heightened risk of attack, with such an agent on either the domestic population (as determined by the Secretary of Homeland Security) or on U.S. military forces (as determined by the Secretary of Defense). Additional requirements for issuance of an EUA include the determination by the HHS/FDA Commissioner that there is no adequate and approved alternative product available to address the specific threat that is causing the emergency declaration, that the known and potential benefits of use outweigh the known and potential risks, and that it is reasonable to believe the product may be effective. The HHS/FDA Commissioner also may establish conditions on an EUA that he finds necessary or appropriate to protect the public health. This section requires the FDA Commissioner (to the extent practicable, given the circumstances of the emergency) to establish certain conditions on an EUA and permits the Commissioner to establish certain other conditions. The EUA expires upon the termination of the emergency declaration, or earlier if the Secretary determines that the emergency has ceased. An EUA may be revoked before termination of the Secretary's declaration if the HHS/FDA Commissioner determines that the criteria for issuance of the EUA are no longer met or that revocation is appropriate to protect public health or safety.

 

The Project BioShield Act of 2004 requires an annual report to Congress to outline the use of these new authorities. This first report provides details of the research and development, acquisition, personnel management, and Emergency Use Authorization (EUA) authorities exercised from enactment of the Project BioShield Act on July 21, 2004 through July 2006.

 

Additionally, on 16 March 2006, before the Senate Committee on Health, Education, Labor and Pensions, Secretary Leavitt announced his intention to establish a dedicated strategic planning function and to streamline and improve the interagency Project BioShield governance process. This report will also discuss these efforts.

[Guest LAW_*]

In accordance with Section 319F-2©(6) of the Public Health Service Act as added by Section 3 of the Project BioShield Act, OMB approval to use the SRF was received on December 7, 2004. HHS awarded two contracts on September 26, 2005, using non-Project BioShield funds to acquire ten grams of product for testing. The contracts also contained options to purchase 10,000-100,000 doses of product with Project BioShield funds. The contracts were awarded a little over one year after receiving Presidential approval for anthrax therapeutics to be added to the SNS. On June 19, 2006, HHS modified its existing contract with Human Genome Sciences of Rockville, Maryland, to include the purchase of 20,001 treatment courses of ABthrax?, an anthrax therapeutic treatment, for a total of $165.2 million. On July 28, 2006, HHS modified its existing contract with Cangene Corporation of Winnipeg, Manitoba, to purchase 10,000 therapeutic courses of treatment of Anthrax Immune Globulin (AIG). The acquisition timeline for anthrax therapeutics is shown in Figure 9.