Public health, when threatened not by Obamacare but by exposure to infectious diseases, natural disasters or chemical, biological, radiological or nuclear (CBRN) agents, is an area where members of Congress have been able to build bipartisanship.
Continuing such cross-party work will be tantamount to ensuring Americans are protected against these increasing and evolving threats, said members of the Senate Health, Education, Labor, and Pensions (HELP) Committee during a Jan. 17 hearing that kickstarted the reauthorization process for the Pandemic and All-Hazards Preparedness Act (PAHPA). Many of the law’s provisions are set to expire in September.
“I look forward to a timely, bipartisan reauthorization of this crucial legislation to ensure we are prepared to respond to natural disasters like hurricanes, and protect Americans against bioterror attacks and infectious disease outbreaks, like the Zika virus or a pandemic influenza,” said U.S. Sen. Lamar Alexander (R-TN), chairman of the HELP Committee.
Several of the committee’s members have been involved from the start in crafting the national legislation designed to protect public health from such threats.
Sen. Richard Burr (R-NC) introduced both Senate versions of PAHPA; the original bill, S. 3678, which became law in 2006, and the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, S. 242, which became law that same year.
“This is the first of two hearings we plan to have on this topic,” said Sen. Burr, who chaired the Wednesday hearing. The next one is scheduled for Jan. 23. He noted the critical importance of both hearings as lawmakers undertake a revamp of PAHPA, particularly because CBRN and other threats, he said, “jeopardize the health of all Americans.”
“Our bipartisan work has resulted in strong partnerships with our states and local counterparts, created greater certainty and accountability to bring forward medical countermeasures, and established a clear strategy with which we can combat the full range of public health threats we face today and those we may encounter in the future,” Burr said during his opening remarks.
“But despite this progress, we’re not fully prepared,” he said, adding that gaps have left the United States vulnerable to terrorists and natural threats.
“I want to make clear to the committee that this is a reauthorization of a national security bill,” Burr said, even though the federal agencies that oversee public health are funded by non-defense monies.
“The threats we face continue to evolve,” he said. “We must bring the vigilance, urgency and resolve this mission demands.”
Developing countermeasures should be “top of mind,” Burr added, saying lawmakers need to ensure that the responsible agencies have what they need to keep pace with rapidly changing and evolving threats.
The leaders of some of those agencies — considered among the nation’s heaviest hitters when it comes to U.S. preparedness and response on the front lines — testified Wednesday during the hearing and said they do indeed need several things in the reauthorization.
Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), for instance, said the office has enough domestic vaccine manufacturing capacity to produce bulk vaccines for each American within six months.
However, emergency supplemental funding has been depleted, he added, and the H7N9 influenza virus is currently circulating in China. “We are concerned with the ominous trends that we are seeing,” Kadlec said.
Referring to the ASPR as the national security mission manager for HHS, Kadlec said the office — which was established a decade ago by PAHPA — consolidates all federal non-military public health and medical preparedness and response functions under its command. ASPR manages the Biomedical Advanced Research and Development Authority (BARDA), Project BioShield and the Public Health Emergency Medical Countermeasures Enterprise, among others that receive funding support under PAHPA.
Dr. Kadlec said that while building up domestic manufacturing capacity may be a one-time expenditure, it costs money to maintain and sustain that capacity. Continuous funding and an ongoing commitment to the medical countermeasures enterprise would help, Kadlec said.
In fact, overall funding just isn’t cutting it.
Kadlec likened ASPR’s financial resources on hand to operating with half an aircraft carrier to complete its mission of protecting the nation’s more than 320 million people.
“And that’s a challenge,” Kadlec said. “We have a $3.3 trillion health care system, of which we invest $250 million for preparedness. It’s a drop in the bucket.”
Sen. Tina Smith (D-MN) mentioned three significant outbreaks that have occurred in her home state recently and financial resources couldn’t cover the expenses. The state turned to the Centers for Disease Control and Prevention (CDC) for assistance, she said, and “through no fault of yours, you also didn’t have any extra money,” she said to witness Dr. Stephen C. Redd, director of the CDC’s Office of Public Health Preparedness and Response.
Minnesota eventually established an emergency response account to quickly deal with such problems, said Sen. Smith, who asked if such a fund would help federal agencies better respond and support the nation.
At HHS there already is such a fund, according to Kadlec, who said it currently has $57,000 in it. What’s preferable, he said, would be a fund containing roughly $2.5 billion to $3.5 billion, based on the costs associated with fighting previous pandemics, and the fund would be managed by the HHS Secretary, who would distribute funds across HHS or to states. And those funds would be deployed rapidly, he said, and accountability would be built in.
“Resources are critical in responding to emergencies,” said Dr. Redd, noting that there were delays in both U.S. responses to recent Ebola outbreaks that hindered efforts. “Something along those lines would be quite helpful,” he said, adding that an expedited or streamlined funding approval process also would ensure that the funds were used more quickly.
Dr. Redd testified in place of CDC Director Dr. Brenda Fitzgerald, who is presently embroiled in financial conflicts of interest.
The CDC’s mission and role in implementing the PAHPRA, Redd said, requires that CDC provides the country’s common defense against public health threats, including infectious diseases, terrorism and natural disasters.
Among its many programs, duties, offices and responsibilities both in the U.S. and internationally, the CDC also operates several public health preparedness programs that were reauthorized by PAHPRA, including the Cities Readiness Initiative, the Strategic National Stockpile (SNS) and biosurveillance, Redd explained.
In fact, the CDC’s mission was set under PAHPRA, said Redd, and includes laboratory testing, surveillance (for disease detection), epidemiology, guidance to healthcare providers, incident management, logistics, emergency risk communication, disease control programs, distribution of medical countermeasures, responder health and well-being, and human and animal medicine.
When asked by Sen. Todd Young (R-IN) how well it was going in the CDC’s fight to limit the transmission of diseases from animals to humans — with the senator admitting that he knew the agency was doing the best it could with the resources it had — Dr. Redd answered: “I think we’re doing well given our reactive strategy.”
The witnesses also all but acknowledged that sometimes reacting is all they feel like they’re doing, particularly when medical supplies or vaccines run low, for example. And maybe that’s something that the reauthorization can address, as well, they said.
Regarding the topic of animals, Dr. Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), pointed out that for many threats there is not yet adequate regulatory science foundation, such as animal models that support medical countermeasure development or sufficient biomarkers to enable the extrapolation of data generated in animal models to humans.
“Without such tools, it is difficult to generate the data necessary to support regulatory decision making,” Gottlieb wrote in his written testimony.
During the hearing, Gottlieb said lawmakers might think about how animal studies could support the development of medical countermeasures.
The Animal Rule, for example, which enables animal efficacy studies to substitute for efficacy trials in humans if the results can reasonably be extrapolated to the expected human use, Gottlieb wrote in his testimony, can be used to facilitate the development and availability of medical countermeasures.
PAHPRA recognized the importance of the Animal Rule and in 2015, Gottlieb said the FDA finalized guidance for product development under the rule, providing scientific and regulatory expectations for animal data intended to support medical countermeasure approval. Thus far, 12 medical countermeasures have been approved under this rule, including inhalational anthrax therapeutics and a botulism antitoxin, he said.
“These approvals underscore the critical role the Animal Rule and animal studies can play in advancing medical countermeasures for some of the world’s most challenging threats,” Gottlieb said.
Senate HELP Committee Ranking Member Sen. Patty Murray (D-WA) said that it’s important for the nation to be cognizant of both local level pandemics and those occurring on a global scale. “Diseases are not stopped by borders, walls or by bans,” she said.
“A pandemic could affect half a billion people; more than the entire population of the United States. And that’s not speculation. It happened a hundred years ago,” Murray said, referring to the 1918 influenza epidemic that eventually caused more deaths than in World War I.
While the nation has become better prepared over the last century in some respects, such as by being able to disperse vaccines to states from the Strategic National Stockpile within 12 hours and in speeding federal approvals for new medical countermeasures to combat anthrax, for example, “our track record is far from perfect,” Sen. Murray said.
For instance, “We can do better than the president’s way-too-slow response in Puerto Rico and the Virgin Islands after Hurricane Maria,” Murray said. “The storm left many people without access to clean water, health care and electricity for months.
“We can do better than the administration’s response to the opioid epidemic,” she added. “President Trump declared the crisis a national health emergency 83 days ago and has taken little meaningful action since.”
Quick bipartisan action is the best response, Murray said, adding that hiring freezes and funding cuts stand to leave the United States less prepared.
During next week’s PAHPA hearing, the senators will hear from non-governmental witnesses, Sen. Alexander said.