CONGRESSWOMAN ELISE STEFANIK
On Tuesday, December 6, 2011, the House is scheduled to consider H.R. 2405, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2011, under a suspension of the rules, requiring a two-thirds majority for passage. H.R. 2405 was introduced by Rep. Mike Rogers (R-MI) on June 28, 2011, and was referred to the House Committee on Energy and Commerce.
H.R. 2405 would amend the Public Health Service Act to revise and reauthorize appropriations for public health preparedness activities, including activities related to:
(1) tracking the initial distribution of federally purchased influenza vaccine in an influenza pandemic;
(2) state and local public health and medical preparedness and response;
(3) improving hospital surge capacity;
(4) expanding the capabilities of the Centers for Disease Control and Prevention (CDC) to respond effectively to bioterrorism and other public health emergencies; and
(5) the operations of the National Disaster Medical System.
The bill would reauthorize appropriations for the special reserve fund for the procurement of security countermeasures. H.R. 2405 would allow 30 percent of such fund to be used by the Biomedical Advanced Research and Development Authority (BARDA) to coordinate the acceleration of advanced research and development of countermeasures and qualified pandemic or epidemic products.
H.R. 2405 would extend the time under which specific technical data or scientific information that is created or obtained during advanced research and development is exempt from disclosure under the Freedom of Information Act (FOIA).
The bill would authorize the Secretary of Health and Human Services (HHS) to determine and pay claims for reimbursement for services provided during a public health emergency.
H.R. 2405 would amend the Pandemic and All-Hazard Preparedness Act to extend provisions granting an antitrust exemption for meetings related to countermeasures or pandemic or epidemic products.
The bill would expand the duties of the Assistant Secretary for Preparedness and Response to include:
(1) stockpiling and distributing qualified countermeasures, security measures, and qualified pandemic or epidemic products;
(2) identifying gaps, duplication, and other inefficiencies in public health preparedness activities and the actions necessary to overcome these obstacles; and
(3) leading the development of a coordinated Countermeasure Implementation Plan.
H.R. 2405 would give the Assistant Secretary authority over and responsibility for BARDA.
Finally, the bill would amend the Federal Food, Drug, and Cosmetic Act to require the Secretary:
(1) to accelerate the development, stockpiling, approval, and licensure of countermeasures and qualified pandemic or epidemic products;
(2) initiate a program of frequent scientific feedback and interactions regarding the process of developing each security countermeasure; and
(3) develop a written regulatory management plan for each security countermeasure.
According to the House Committee on Energy and Commerce House Report 112-286, in the wake of the September 11th terrorist attacks, Congress took important steps to build the nation's health infrastructure and foster the development of CBRN (Chemical - Biological - Radiological – Nuclear) MCMs (Medical Countermeasures) to enable the nation to better respond to CBRN attacks. As part of these steps, Congress enacted two key pieces of legislation, the “Project BioShield Act of 2004” and the “Pandemic and All-Hazards Preparedness Act of 2006” (PAHPA), and they have dramatically improved our nation's ability to respond to public health emergencies and disasters, including those caused by terrorism. The “Pandemic and All-Hazards Preparedness Reauthorization Act of 2011” would reauthorize and improve certain provisions of Project BioShield and PAHPA in order to increase certainty and predictability, clarify the role of the Assistant Secretary for Preparedness and Response (ASPR) as the leader of preparedness and response, and strengthen our nation's preparedness infrastructure.
The 108th Congress passed Project BioShield to encourage the private sector to develop MCMs against CBRN agents that would not otherwise have a commercial market and bring certainty and predictability to the MCM development space. Project BioShield included provisions that, among other things, authorized funds for the purchase of MCMs through the Special Reserve Fund (SRF) and enabled the Secretary of the Department of Health and Human Services (HHS) to authorize the emergency use of medical products. The SRF was intended to be a secure funding source for the procurement of critical MCMs; it is critical because it clearly demonstrates the Federal government's commitment to MCM procurement. By increasing certainty and predictability, which this legislation seeks to do through the reauthorization of the Special Reserve Fund and the Biodefense Advanced Research and Development Authority (BARDA) as well as the establishment of the Regulatory Management Plan process, among other provisions, H.R. 2405 would build on the provisions of Project BioShield to encourage investment, research, and development and increase the likelihood of securing the MCMs necessary to protect our citizens during health emergencies and disasters, including those caused by terrorism.
Shortly after the enactment of Project BioShield, the 109th Congress passed PAHPA, which reauthorized a number of expiring preparedness and response programs in the Public Health Service Act and established several new authorities. For instance, PAHPA established the Biomedical Advanced Research and Development Authority (BARDA), a new authority within the Department of Health and Human Services (HHS), to foster advanced MCM development and facilitate interactions between HHS and MCM developers. PAHPA also established a crucial new position at HHS, the Assistant Secretary for Preparedness and Response, to lead the Federal government's efforts and coordination for CBRN preparedness and response. H.R. 2405 includes provisions to clarify that the ASPR has lead responsibility within HHS for emergency preparedness and response policy and coordination. Finally, PAHPA included provisions to build the nation's public health infrastructure. The provisions of H.R. 2405 would reauthorize many of these PAHPA provisions to continue the effort to strengthen our nation's preparedness infrastructure.
The Congressional Budget Office (CBO) estimates that implementing H.R. 2405 would cost $395 million in 2012 and $7.9 billion over the 2012-2016 period, assuming the appropriation of the authorized amounts. The funding authorized by H.R. 2405 is similar to the appropriation amounts enacted in recent years for the same activities. Pay-as-you-go procedures do not apply to this legislation because it would not affect direct spending or revenues.