U.S. Sen. Richard Burr (R-NC), the original sponsor of America’s law safeguarding public health during man-made or natural disasters and a leader in its subsequent restructuring, presided over two hearings convened this month by the Senate Health, Education, Labor, and Pensions (HELP) Committee aimed at updating the law once again.
The hearings are especially timely for two reasons: Many of the provisions in the Pandemic and All-Hazards Preparedness Act (PAHPA) are set to expire in September, and currently, the nation is experiencing the most widespread flu season since health officials started tracking it 13 years ago, according to the Centers for Disease Control and Prevention (CDC). The influenza outbreak is so severe and worsening that many lives have been lost, particularly among young children, the CDC reports.
HELP Committee Chairman Sen. Lamar Alexander (R-TN) deferred oversight of the hearings to Sen. Burr, a senior HELP Committee member, based on his experience with PAHPA. Burr introduced both Senate versions of the PAHPA, the original bill, which became law in 2006, and the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which became law that same year. Many members on the HELP Committee also had a hand in crafting both the original and first reauthorization of PAHPA, Sen. Alexander noted during both hearings.
PAHPA authorizes funding for public health and medical preparedness programs, medical countermeasures under the Project BioShield Act, and development of potential medical countermeasures, according to the U.S. Department of Health and Human Services (HHS). The law also supports the U.S. Food and Drug Administration’s (FDA) public health emergency rapid-response measures, among other purposes.
The first hearing Sen. Burr chaired on Jan. 17 included testimonies from federal experts: Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response (ASPR) at HHS; Dr. Scott Gottlieb, commissioner of the FDA; and Dr. Stephen C. Redd, director of the CDC’s Office of Public Health Preparedness and Response. They encouraged lawmakers to include increased, consistent annual funding in the PAHPA reauthorization to support a number of federal agencies, departments and programs targeting U.S. preparation and response capabilities during a catastrophic event linked to infectious diseases, natural disasters or chemical, biological, radiological or nuclear (CBRN) agents.
The second hearing held on Jan. 23 provided lawmakers with the private-sector perspective, as well as that of hospitals — with testimonies from Brent MacGregor, senior vice president of commercial operations at Seqirus, a leading global influenza vaccine developer and manufacturer; Dr. Tom Inglesby, director of the Center for Health Security at Johns Hopkins Bloomberg School of Public Health in Baltimore; Dr. Steven Krug, head of pediatric emergency medicine at the Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics at Northwestern University’s Feinberg School of Medicine; and Dr. John J. Dreyzehner, commissioner of the Tennessee Department of Health in Nashville.
Sen. Burr noted the importance of PAHPA’s support for the Biomedical Advanced Research and Development Authority (BARDA) within ASPR to develop influenza vaccines, and said, “BARDA’s known for its work to advance new and innovative technologies to better combat public health threats.” BARDA also has successfully developed novel ways, such as platform technologies, to develop medical countermeasures, he said, asking witnesses what challenges BARDA faces in bringing such technologies “through the medical countermeasure pipeline.”
MacGregor testified that he would like to see government investments and partnerships with BARDA continue, such as the one BARDA has with Seqirus at its Holly Springs, N.C., plant, where “new and innovative platform technologies” are being used to develop vaccines.
MacGregor told the panel that the firm’s interaction with BARDA “has been very strong,” enabling Seqirus to improve yields, potentially getting vaccines to market sooner during seasonal or pandemic outbreaks.
Their partnership, MacGregor said, has allowed Seqirus “to continue to advance the effectiveness of cell-based technology,” an example of a platform technology that the federal government is investing in as a potential for providing a better match — or vaccine antigen-to-circulating virus — “in the event of a mismatch season, as we’re experiencing this year.”