Decreased and episodic funding from the United States government has stakeholders questioning the true commitment federal lawmakers have for sustaining the nation’s preparedness and response capabilities during a catastrophic event linked to infectious diseases, natural disasters or chemical, biological, radiological or nuclear (CBRN) agents.
It’s a modern twist on the continued need for the increased, consistent federal funding needed under the Pandemic and All-Hazards Preparedness Act (PAHPA), a fact highlighted by witnesses during a Jan. 23 hearing held by the Senate Health, Education, Labor and Pensions (HELP) Committee. Many provisions in the 2006 PAHPA law, reauthorized most recently in 2013, are set to expire in September. HELP Committee members held their second hearing in two weeks to inform their work toward updating the law again this year.
Last week, witnesses provided the administration’s perspective on the nation’s preparedness and response capabilities for facing 21st century public health threats, while this week’s four witnesses hailed largely from the private sector. And like those before them, witnesses on Tuesday expressed concerns about decreased or lack of federal funding for such work — to the point that it’s ruining the U.S. government’s reputation not only with specific corporations, but with public health and medical professionals and with Americans, as well.
“Unfortunately, over the last several years, the private sector has become more skeptical of the government’s commitment to biodefense,” testified Brent MacGregor, senior vice president of commercial operations at Seqirus, a leading global influenza vaccine developer and manufacturer.
Seqirus is part of a public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), which is managed by the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).
Seqirus operates a state-of-the-art vaccine production facility in Holly Springs, N.C., a facility characterized as “one of the best examples of a public-private partnership envisioned by the authors of PAHPA when it was originally signed into law,” MacGregor said.
Currently, the partners are working on candidate vaccines against the H7N9 strain that’s circulating in China. The ASPR expressed heightened concern about the evolving strain during the HELP Committee’s Jan. 17 hearing.
But BARDA’s funding under PAHPA “has been largely episodic funding since 2009,” MacGregor testified, adding that emergency supplemental monies provided during pandemics in 2005 and 2009 “have been fully exhausted.”
Worse yet, “despite representing the ‘P’ in PAHPA, authorized funding for pandemic influenza preparedness has never been included in this legislation” for BARDA, he told the senators.
“Having a program authorized by Congress will provide a clear signal to the private sector that the U.S. government is committed to preparing against pandemic threats in the future,” said MacGregor, who also called for an annual authorized funding level of at least $535 million to support HHS pandemic influenza activities.
At the same time, MacGregor said that while PAHPA has helped create a biodefense enterprise at HHS that’s greatly improved national security and made it more attractive for companies like Seqirus to invest in partnerships with the U.S. government, improvements are needed around medical countermeasures (MCMs).
For instance, the federal government’s lack of multiyear funding for the Project BioShield Special Reserve Fund “has created uncertainty in the long-term sustainability of MCM programs,” MacGregor testified.
Sustained and predictable funding, along with better coordination and communication within the federal government, would provide more certainty to government partners and improve market certainty for MCM development, MacGregor said.
That certainty is critical because a commercial MCM market doesn’t exist, so companies can only rely on commitments from HHS to continue making investments in MCM research, said MacGregor. “Public-private partnerships must be sustained over time to demonstrate a commitment by the federal government,” he said.
Commitments that support the people who run preparedness and response work on the ground also are needed from the feds, testified Dr. John J. Dreyzehner, commissioner of the Tennessee Department of Health in Nashville.
Having a strong public health and medical preparedness and response system for the country requires consideration under PAHPA of not just “the stuff” — like medical supplies, drugs and vaccines, equipment, facilities, etc. — but the people doing the actual work, too, Dreyzehner said.
“They run the response. The anchors are important, but the people run the response,” he said, adding that they can’t be trained after the alarm sounds.
The PAHPA reauthorization, Dreyzehner said, should provide funds for training people, among other items. And training should be done beforehand, not after. “It has to be in place before the show starts, before the threat emerges,” he said. When such support is in place, such as by providing stable and consistent funding for the HHS Hospital Preparedness Program (HPP), then trust will improve among public health and medical professionals, as well as communities and residents, of the government’s commitment to these efforts, he said.
Agreeing with that assessment was Dr. Tom Inglesby, director of the Center for Health Security at Johns Hopkins Bloomberg School of Public Health in Baltimore, where he’s also a professor of medicine and public health.
Since 2001 there have been concerted efforts at various levels of government to improve preparedness and response efforts, but “there’s too much to do and not enough trained professionals to do the work,” Dr. Inglesby said.
And while public health threats haven’t declined, funding has, including for the HPP, which has experienced significant funding constraints that have reduced its budget 50 percent since 2002, Inglesby said, adding that the Centers for Disease Control and Prevention’s preparedness funding grants also have decreased 30 percent since 2003.
“This trend should be reversed,” Inglesby said, saying it’s time to strengthen the nation’s health care preparedness system and enable it to care for high numbers of sick people.
“The U.S. faces a range of major public health threats, any of which could occur without much warning,” said Inglesby, who listed natural disasters, technological accidents, mass shootings and bombings, chemical spills and the potential use of CBRN threats.
Biological threats — whether natural or accidental (like a virus outbreak or the spread of a disease by a rat) — or deliberate, like smallpox or anthrax, are of particular concern to Inglesby, who said they can range in size from modest to catastrophic. And currently, the U.S. preparedness and response system isn’t adequately positioned to handle the latter, he said.
“The system needs people,” agreed Dr. Steven Krug, head of pediatric emergency medicine at the Ann and Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics at Northwestern University’s Feinberg School of Medicine.
“We need to direct more future people toward these careers. If we redirect the flow, we’ll be better prepared to deal with a calamity,” said Krug, who is also chairman of the Disaster Preparedness Advisory Council at the American Academy of Pediatrics.
Dr. Dreyzehner added that such “highly committed professionals need certainty about whether the careers they’ve dedicated their lives to will continue to be funded” and if preparedness and response in the public health profession will continue. PAHPA could provide those assurances, he said.
Even Senate HELP Committee hearing chairman U.S. Sen. Richard Burr (R-NC), who crafted the original PAHPA and helped spearhead its 2013 reauthorization, noted the law’s importance to building commitment between the public and the government.
Since its last update, PAHPA has “been tested by pandemic flu, multiple natural disasters, an Ebola outbreak, and a zika virus,” Burr said. “The last hurricane season brought three devastating storms that raised new questions about our ability to manage and withstand multiple periods of response.
“We cannot let up on the urgency this mission demands,” said Burr.