Project BioShield Act of 2003 - Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.
Grants the Secretary of Health and Human Services (Secretary), through the National Institutes of Health (NIH), certain authority with respect to the research and development of qualified biomedical countermeasures, including: (1) expedited procurement authority; (2) expedited peer authority; and (3) authority for personal services contracts.
Directs: (1) the Secretary of Homeland Security to assess current and emerging chemical, biological, radiological, and nuclear threats, and determine which present a material risk to the United States; and (2) the Secretary to assess the public health consequences of such threats, and the availability and appropriateness of countermeasures. Authorizes the Secretaries to jointly propose to the President appropriate countermeasures and procurement. Directs the Secretaries, upon presidential approval, to procure the necessary countermeasures for stockpiling.
Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release into interstate commerce of a drug or device intended for use in an emergency. Directs the Secretary, as feasible, to: (1) impose requirements on such authorization, including emergency product labeling and ensuring that health care professionals administering the product and persons to whom the product is administered are informed about benefits, risks, and alternatives; and (2) periodically review, or revoke as circumstances warrant, an authorization. Provides civil monetary penalties for violations of such provisions. Allows the President, under specified circumstances involving the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure.
Amends the Social Security Act to revise the Secretary's authority to waive specified requirements during a national emergency.