CONGRESSWOMAN ELISE STEFANIK
On Wednesday, December 19, 2012, the House is scheduled to consider H.R. 6672 under a suspension of the rules requiring a two-thirds majority vote for passage. The bill was introduced by Rep. Mike Rogers (R-MI) on December 17, 2012, and referred to the Committee on Energy and Commerce and the Committee on Veteran’s Affairs.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2012 (PAHPRA) would reauthorize programs designed to foster the development of chemical, biological, radioactive and nuclear (CBRN) medical countermeasures (MCM) and strengthen the nation’s preparedness infrastructure. PAHPRA would reauthorize these programs for five years at the Fiscal Year 2012 appropriated level.
TITLE I— Strengthening National Preparedness and Response for Public Health Emergencies
Sec. 101. National Health Security Strategy: This section would make changes to the National Health Security Strategy on public health emergency preparedness and response, such as incorporating dental care into the medical preparedness goals. The section also would require the Department of Health and Human Services (HHS) to improve public health emergency preparedness, response, outreach and communication with respect to children, pregnant women and senior citizens.
Sec. 102. Assistant Secretary for Preparedness and Response: The section would clarify that the Assistant Secretary for Preparedness and Response (ASPR) has lead policy and coordination responsibilities within HHS with respect to emergency preparedness and response.
Sec. 103. National Advisory Committee on Children and Disasters: The National Advisory Committee on Children and Disasters would be authorized to continue the work of the Children’s HHS Interagency Leadership on Disasters (CHILD) Working Group and the National Commission on Children and Disasters to improve our nation’s ability to care for children affected by disasters.
Sec. 104. Modernization of the National Disaster Medical System: This section of the bill would reauthorize the National Disaster Medical System, at $52.7 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level. The National Disaster Medical System assists in managing the federal government’s medical response to major emergencies and disasters.
Sec. 105. Continuing the role of the Department of Veterans Affairs: This section of the bill would improve the readiness of Veterans Affairs medical centers and research facilities with respect to a chemical, biological, radiological and nuclear (CBRN) attack. It would reauthorize Veterans Affairs CBRN response programs at $155.3 million for Fiscal Years 2013 – 2017, which is the Fiscal Year 2012 appropriated level.
TITLE II— Optimizing State and Local All-Hazards Preparedness and Response
Sec. 201. Temporary redeployment of federally funded personnel during a public health emergency: The section would allow states and tribes to ask the HHS Secretary to redeploy personnel funded by the federal government to respond to public health emergencies. This process could be initiated only at the request of the state or tribe. This authority would sunset in five years, and the section would authorize the Government Accountability Office (GAO) to study, four years after enactment, whether this authority saved money and fostered more effective disaster response.
Sec. 202. Improving State and local public health security: This section would reauthorize the Public Health Emergency Preparedness Cooperative Agreement (PHEP) program administered by the Centers for Disease Control and Prevention at $641.9 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level. This section also would reauthorize the vaccine tracking and distribution program used during an influenza pandemic at $30.8 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level.
Sec. 203. Hospital preparedness and medical surge capacity: This section would reauthorize the Hospital Preparedness Program (HPP) at $374.7 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level. The bill includes language that would require the awardees to take into account the needs of children and other at-risk populations. The bill also would require the HHS Secretary to implement evidence-based metrics to ensure that those receiving awards meet the goals of the National Health Security Strategy.
This section would also reauthorize the Medical Reserve Corps at $11.2 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level. The Medical Reserve Corps engages local volunteers to strengthen emergency response and community resiliency.
This section would also reauthorize the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP) program at $5 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level. The ESAR-VHP program supports states and territories in establishing standardized volunteer registration programs for disasters and public health emergencies. Lastly, this section would incorporate dentists into the all-hazards public health and medical response curricula and training.
Sec. 204. Enhancing situational awareness and biosurveillance: The section would reauthorize the federal, state, and local surveillance and situational awareness capacity program at $138.3 million each year for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level. This section would also make poison control centers eligible for this program.
Sec. 205. Eliminating duplicative Project Bioshield reports: This section would repeal a report included in the Project BioShield Act of 2004 that is duplicative of parts of the Strategy and Implementation Plan referenced in Section 102.
TITLE III— Enhancing Medical Countermeasure Review
Sec. 301. Special protocol assessment: The section would increase regulatory predictability for medical countermeasure (MCM) sponsors by expanding the use of Special Protocol Assessments to animal trials and any associated clinical trials necessary to support licensure of MCMs.
Sec. 302. Authorization for medical products for use in emergencies: This section would amend the Food and Drug Administration’s (FDA) current Emergency Use Authorization (EUA) authority to enable FDA to authorize the distribution, stockpiling and use of MCMs before an actual emergency, thus allowing FDA to take important, life-saving steps before the emergency actually occurs.
The section also would enable FDA to do the following: (1) extend the expiration date for MCMs intended to be used for emergency responses; (2) grant waivers of current Good Manufacturing Practices; (3) authorize emergency dispensing of MCMs during an actual emergency without an individual prescription if permitted under State law or permitted by an order of the HHS Secretary; (4) work with other HHS agencies to create and issue emergency use instructions concerning a product’s conditions of use; and (5) authorize FDA to waive a product’s Risk Evaluation and Mitigation Strategy if necessary.
Sec. 303. Definitions: This section would add definitions of security countermeasure, qualified countermeasure and qualified pandemic or epidemic product to the Federal Food, Drug and Cosmetic Act.
Sec. 304. Enhancing medical countermeasure activities: This section would increase FDA interaction with countermeasure sponsors and require the FDA to provide additional clarity around the requirements of the approval, clearance and licensure processes for MCMs.
Sec. 305. Regulatory management plans: This section would require the FDA to establish a process for frequent scientific feedback and interaction with countermeasure sponsors whose MCMs have been procured through the Special Reserve Fund (SRF) in order to facilitate the approval, clearance and licensure of the MCMs. Under the section, FDA would also have the authority to apply this process to MCMs that are not security countermeasures.
Sec. 306. Report: This section would require the FDA to annually report on MCM development and review activities starting six months after the enactment of the bill.
Sec. 307. Pediatric medical countermeasures: This section would make improvements to current law in order to better address the needs of children in MCM development.
TITLE IV— Accelerating Medical Countermeasure Advanced Research and Development
Sec. 401. BioShield: This section would reauthorize the Project BioShield SRF, at $2.8 billion over five years (Fiscal Years 2014 –18). This level of funding is consistent with the SRF’s original 10-year appropriation of $5.6 billion for Fiscal Years 2004 – 2013. The section would also prohibit SRF funds from being used for anything other MCM procurement, research and development; require the HHS Secretary to provide a report to Congress when funds available in the SRF go below $1.5 billion; allow the use up to 50 percent of funds available in the SRF for advanced research and development of medical countermeasures at the Biomedical Advanced Research and Development Authority (BARDA). These funds would supplement, not supplant, BARDA’s funding through the annual appropriations process.
Sec. 402. Biomedical Advanced Research and Development Authority: This section would reauthorize BARDA at $415 million each year for five years (Fiscal Years 2013 –17), which is the Fiscal Year 2012 appropriated level. The section also would extend limited anti-trust exemptions for meetings regarding MCM development that include national security information.
Sec. 403. Strategic National Stockpile: This section would reauthorize the nation’s Strategic National Stockpile at $533.8 million for five years (Fiscal Years 2013 – 2017), which is the Fiscal Year 2012 appropriated level.
Sec. 404. National Biodefense Science Board: This section would add pediatric and state/local expertise to the National Biodefense Science Board.
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.
H.R. 2405 passed the House by voice on December 6, 2011. H.R. 6672 represents negotiations with the Senate on H.R. 2405.
A CBO score of H.R. 6672 was not available as of press time.