For decades, Congress has passed legislation to protect Americans from public health emergencies, ranging from national security threats to disease outbreaks and natural disasters, but that protection has lapsed.
The Biotechnology Innovation Organization (BIO) is working to support Congress in ensuring our national health security by reauthorizing the Pandemic and All Hazards Preparedness Act (PAHPA) before year’s end. In a recent action, BIO joined over 80 other organizations and companies in signing a Sept. 14 letter urging congressional leaders to pass a PAHPA bill.
“This is a national security priority, an important way to protect Americans,” explains Phyllis Arthur, BIO’s EVP and Chief of Global Health. “PAHPA funds so many things that are essential for our national readiness and resilience. We are at a time when Americans care a great deal about what’s happening in terms of our nation being ready for known and unknown threats.”
Historically reauthorized on a five-year basis since it was initiated in 2005, PAHPA has not been reauthorized after the previous funding period ended in September 2023. While most PAHPA programs continue with short-term, temporary extensions, five-year funding is essential to incentivize research and development in medical countermeasures (MCMs), which can often take more than a decade to develop.
As a national security measure protecting civilians and the military, PAHPA has bipartisan support in Congress, and there is reason for optimism about reauthorization before the end of the year, according to Praneel Jadav, Manager, Infectious Disease Policy at BIO. “We commend the bipartisan champions in the House and Senate who are working to reauthorize PAHPA and we are committed to supporting their efforts,” he says.
While Congress has not yet put forth a bill for PAHPA reauthorization, it is expected to be aligned with earlier legislative proposals that BIO would support, according to Jadav. He says BIO’s priorities for any PAHPA legislation are:
- Reauthorization of several key Administration for Strategic Preparedness and Response (ASPR) programs, including the Biomedical Advanced Research and Development Authority (BARDA), the Strategic National Stockpile (SNS), Project BioShield, and the Pandemic Influenza Program.
- Reauthorization of the Medical Countermeasure Priority Review Voucher (MCM PRV) program.
- Authorization of a Pathogen-Agnostic Viral Family program at BARDA.
Why ASPR matters
ASPR oversees most public health preparedness efforts and programs, including BARDA. BARDA works with industry to support the late-stage development of MCMs against chemical, biological, radiological, and nuclear threats, and emerging infectious diseases, all of which pose a real and present danger, Arthur explains.
“We know for instance that a flu pandemic is a threat every single year,” she says. “BARDA has been seeking to support companies working on vaccines against the various flu pandemic strains that pop up all over the world.”
ASPR also oversees the Strategic National Stockpile (SNS), a ready supply of MCMs ranging from smallpox vaccines to treatments protecting members of the military against nerve agents. Other vital ASPR programs include Project BioShield, which provides money and market incentives for private development of life-saving products that lack a commercial market.
Why the MCM PRV matters
An important part of the work PAHPA supports is industry-government collaboration to ensure drug companies develop new MCMs against potential threats and produce these drugs for stockpiling in the SNS.
“You can’t be standing around waiting for drug development in an emergency,” Arthur says. But since the hope is that we never need to use MCMs, regular market considerations would not encourage their development.
“We must have MCMs ready, though they often cannot be supported commercially,” Arthur explains. “Their marketplace is primarily government, and the U.S. government is the main global purchaser.”
Government support for this type of drug development is vital because most early research and development of MCMs is handled by small and mid-sized biotechs, with moderate budgets, Jadav notes.
“Anything we can do to show there is government support really helps these companies make a case with investors to continue funding innovative medical countermeasures that protect both civilians and the warfighter,” he says.
One mechanism to reduce the financial risks of developing a new MCM is the MCMPRV, a voucher that grants developers of MCMs priority Food and Drug Administration (FDA) review of a future drug candidate.
The faster time to market is a financial boost to drug developers, and MCM developers seeking capital can also sell the vouchers to other companies. While vouchers offer real value for drug makers, they cost taxpayers nothing.
Why viral families matter
Another key PAHPA initiative BIO wants to see is authorization of a dedicated Pathogen-Agnostic Viral Family program at BARDA. Examples of viral families include mpox and smallpox, which are both treated with one vaccine. We can more quickly achieve a range of treatments by developing vaccines or antivirals for other viral families—like the family that includes Marburg and Ebola, or the COVID-SARS-MERS family.
“This is more of a progressive method to address threats in emerging infectious diseases,” says Jadav. “It focuses research on medical countermeasures that address a whole host of viruses instead of doing a one bug, one drug approach.”
While BARDA has initiatives to encourage MCMs for viral families, a dedicated program would improve efficiencies in this area.
With PAHPA’s power to promote these essential health defense measures, BIO and its co-signers on the Sept. 14 letter to Congress see risks in delaying the legislation.
“Failing to reauthorize PAHPA now would have serious effects on our country’s economic wellbeing, national security, and health given the rapidly changing threat landscape,” the letter explains.
