Revises provisions permitting the Secretary to authorize the use of unapproved medical products or the unapproved use of an approved product, including to:
(1) allow the Secretary to base the determination on a threat (rather than a specific threat as under current law);
(2) allow the Secretary to base the determination on a significant potential for a public health emergency;
(3) allow the Secretary to base the determination on the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad;
(4) eliminate the one-year expiration date; and
(5) allow a person to revise the label to reflect the new expiration date.
Authorizes the Secretary to extend the expiration date of eligible medical countermeasures if the Secretary determines:
(1) that the extension will help protect public health;
(2) the extension is supported by scientific evaluation that is conducted or accepted by the Secretary;
(3) what changes to the product labeling, if any, are required or permitted; and
(4) that any other conditions that the Secretary deems appropriate have been met.
Authorizes the Secretary to permit deviations from good manufacturing practice requirements when the circumstances of a domestic, military, or public health emergency or material threat so warrant.
Authorizes the Secretary to waive requirements for a risk evaluation and mitigation strategy for domestic, military, and public health emergencies (currently, such waiver authority applies only to public health emergencies) and for the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad.
Permits a government entity to introduce into interstate commerce a product intended for emergency use if that product is intended to be held and not used, and is held and not used, unless and until it is:
(1) approved, cleared, or licensed;
(2) authorized for investigational use; or
(3) authorized for emergency use.
Requires the Secretary to:
(1) ensure the appropriate involvement of FDA personnel in interagency activities related to countermeasure advanced research and development,
(2) ensure the appropriate involvement and consultation of FDA personnel in flexible manufacturing activities,
(3) promote countermeasure expertise within the FDA, and
(4) maintain teams composed of FDA personnel with expertise on countermeasures.
Requires the Secretary to establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigation device exemption, may request and receive:
(1) a meeting to discuss proposed animal model development activities, and
(2) a meeting prior to initiating pivotal animal studies.
Requires such meetings to include discussion of animal models for pediatric populations, as appropriate.
Requires the Secretary to take into account the material threat posed by the chemical, biological, radiological, or nuclear agent for which the countermeasure under review is intended when evaluating a countermeasure for approval, licensure, or clearance.
Directs that, when practicable and appropriate, teams of FDA personnel reviewing applications or submissions shall include a reviewer with sufficient training or experience with countermeasures pursuant to established protocols.
Requires the Secretary to establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans.
Allows prioritization of countermeasures to receive regulatory management plans if the Commissioner of Food and Drugs determines that resources are not available to establish regulatory management plans for all eligible countermeasures.
Directs the Secretary to submit to the specified congressional committees a report detailing the countermeasure development and review activities of the FDA. Requires the Secretary to solicit input from the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority (BARDA) regarding pediatric studies for medical countermeasures.
Requires the Secretary to notify the Assistant Secretary and the Director of BARDA of all pediatric studies in the written request for a pediatric study issued by the Commissioner of Food and Drugs.