Sustainable federal funding to develop and stockpile medical countermeasures is critical to the security and public health emergency preparedness of the United States, panelists said during a Bipartisan Policy Center event on Tuesday.
And medical countermeasures are needed now as the United States and the world face continued risks from chemical, biological, radiological, and nuclear (CBRN) agents or a natural disease pandemic.
“We are still not ready for some of the unknown threats, but we are ready for others. We’ve made a lot of progress, but there’s a lot of work yet to be done,” said Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA) and acting deputy assistant secretary in the Office of the Assistant Secretary for Preparedness and Response, both part of the U.S. Department of Health and Human Services (HHS).
Bright came up against a real-life example earlier this month. U.S. officials were assessing an emergency stockpile of its vaccines against the H7N9 bird flu virus, which resurged in China this winter and infected and/or killed hundreds of people. Bright publicly announced that the stored H7N9 vaccine wouldn’t adequately protect against a new family of these viruses from China, known as the eastern or Yangtze River Delta lineage of the viruses. And he said a new vaccine is needed.
BARDA, which develops and provides medical countermeasures to man-made and natural threats — including CBRN threats, pandemic influenza and emerging infectious diseases — supports product innovation, advanced development, acquisition and stockpiling, and building manufacturing infrastructure. To get the work done for, say, ramping up a new vaccine that could be developed, approved and then stockpiled for millions of people, BARDA works closely with many partners, including private industry partners that want to be paid up front on their government contracts.
But as G. William Hoagland, senior vice president at the Bipartisan Policy Center, pointed out using an HHS funding chart, BARDA was flat-funded for 2016 and 2017 at $512 million.
Likewise, the budget for the nation’s Project BioShield, enacted by Congress in 2004 to purchase medical countermeasures for use during a bioterrorist attack, lost $160 million in federal monies from 2016 funding of $510 million to 2017 funding of $350 million.
“This has been a significant hit, particularly for the companies we’re working with,” Bright said.
That point isn’t lost on Wall Street, said Phyllis Arthur, managing director of infectious diseases and diagnostics policy for the Biotechnology Innovation Organization. She said her group works with many companies that all are experiencing similar problems doing business with the government: it’s risky.
“While a lot of companies seek to grow their businesses and brands, they also want to have the opportunity to deliver on the public health mission. Their executives view that as being highly valuable — it may even be part of their corporate mission. But their investors say the opposite. They say that the value of working with DOD or BARDA is zero,” Arthur said.
That’s partly due to bureaucracy, according to one former lawmaker. BARDA is under HHS, for instance, and Project BioShield is associated with the National Institutes of Health and the U.S. Food and Drug Administration.
“There are too many siloed decisions right now. We need to make some progress here. We’re not ready for Ebola to hit or for Zika to become more consequential or for other pathogens to hit. We need to bring the government together more effectively,” said Tom Daschle, former U.S. Senate majority leader and the former senator of South Dakota.
Daschle and one of his former colleagues, Judd Gregg, former chairman of the U.S. Senate Budget Committee and former senator of New Hampshire, suggested that BARDA be moved into the Department of Homeland Security.
Once there, they also suggested it receive advanced funding, which Project BioShield initially received for 10 years. It’s basically the theory of designating money now to fund a future benefit.
For example, when letters laced with anthrax were mailed to congressional members on Capitol Hill in 2001, Gregg spearheaded advanced funding as part of a response to jumpstart medical countermeasures.
“The only way to get drug companies to produce [in response] … was to give them the funding resources so that they’d put in their own capital to make the vaccines. We had to advance fund those contracts for the sake of national security,” Gregg said.
“And it worked rather well,” he added. “So how do you get Congress back into this funding mode without having a crisis at hand? We have to express the magnitude of the impact [of these threats] on national security. Nothing could be more devastating.”
In fact, new threats like the chemical and nerve agents being used in Syria and North Korea are being used abroad and panelists agreed it’s only a matter of time until they reach American soil.
“We need to increase our medical countermeasures efforts. We need to make sure we’re doubling down on our efforts to sustain what we’ve built…what we will build. We have to bring a 21st century response to these 21st century threats,” Bright said.