Project BioShield Act of 2003
| Date | Chamber | What was voted on | Result | Yes–No | |
|---|---|---|---|---|---|
| Jul 16, 2003 | House · vote #373 | On Passage | Passed | 421–2 | See who voted → |
Grants the Secretary of Health and Human Services (the Secretary) certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer authority; and (3) authority for personal services contracts.
Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (2) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary.
Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug or device intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, under specified circumstances in cases involving the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure.
Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office.
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 214.