Background – PAHPA
• The Pandemic and All Hazards Preparedness Act (PAHPA) was first passed in 2006 and is due to be reauthorized by Congress this year. PAHPA created the Biomedical Advanced Research and Development Authority (BARDA) and other federal initiatives to respond to public health emergencies.
• PAHPA reauthorization is a good opportunity for IDSA to advocate for additional programs or policies to strengthen our public health emergency preparedness and response capabilities. This year, IDSA is urging Congress to provide loan repayment for physicians who participate in CDC’s Epidemic Intelligence Service (EIS) and to create a new incentive for antibiotic research and development.
Background – EIS Loan Repayment
• ID physicians play important roles in public health emergency preparedness and response, including surveillance, institutional bioemergency preparedness, and research for new vaccines, diagnostics and therapeutics.
• Unfortunately, the waning pipeline of ID physicians is limiting our public health preparedness and response workforce.
• CDC’s Epidemic Intelligence Service (EIS) is a two-year fellowship where participants receive on-the-job training to respond to infectious disease outbreaks and other public health emergencies on a population level. EIS was created in the 1950’s due to concerns about bioterror during the Korean war and since then has been on the frontlines of every major public health crisis, including the 9/11/01 attacks, anthrax attacks, the 2014-15 Ebola outbreak, Zika outbreak, and the 2017 major hurricanes.
• Unfortunately, EIS has faced significant challenges recruiting new physicians (as high medical student debt draws students to more lucrative opportunities) forcing EIS to reduce its capacity.
• Loan repayment programs offered through NIH and HRSA’s National Health Service Corps help reduce medical student debt and encourage individuals to pursue careers as biomedical researchers and physicians caring for underserved communities.
• Nothing exists for individuals who want to work in public health preparedness and response, despite similar needs and challenges.
• While CDC had statutory authority for student loan repayment from 1995 to 2002, funds were not appropriated, so the authority was never used. This now-expired authorization also required a longer service agreement than the EIS fellowship, making it essentially moot for physicians who wanted to participate.
Background – AMR as a Security Issue and the Need for an Antibiotic R&D Incentive
• If an antibiotic resistant pathogen were weaponized and used against the US, we are ill-prepared.
• Antibiotic resistance can significantly complicate responses to many other emergencies. For example, significant wounds and/or burns resulting from a terrorist attack can easily become infected. Increasing rates of antibiotic resistance and inadequate antibiotic innovation leave us with frighteningly few and, in some cases, no treatment options for these infections.
• Many influenza hospitalizations/deaths are attributable to secondary bacterial pneumonia, which is increasingly complicated by AMR.
• Despite a growing need for new antibiotics, the antibiotic pipeline remains fragile. Most large pharmaceutical companies have left the antibiotics market because antibiotics provide little opportunity for return on investment (they are used for short durations and held in reserve to protect their utility).
• The Biomedical Advanced Research and Development Authority (BARDA) is making important investments in antibiotic R&D, but a new incentive is needed to encourage private investment.
IDSA Policy Proposals
• EIS Loan Repayment: IDSA proposes reauthorizing CDC loan repayment and reducing the 3-year service agreement to 2.
• Antibiotic R&D Incentive: IDSA proposes a market entry reward ($500 million) for new antibiotics that treat serious or life-threatening infections and address unmet medical needs. Companies that receive such rewards should be required to commit to antimicrobial stewardship and appropriate access.
o Market Entry Rewards (MERs) could be administered by BARDA over a 5-year period following FDA approval.
o Incentive should be very narrowly targeted to antibiotics that address urgent unmet medical needs.
o IDSA is flexible on policy details and open to other incentive ideas.
Current Status – PAHPA
• The Senate HELP Committee’s PAHPA reauthorization bill (passed by the Committee in May) provides new authority for the Biomedical Advanced Research and Development Authority (BARDA) to undertake new strategic initiatives on antimicrobial resistance and antibiotic research and development.
• The bill also increases BARDA’s authorized funding level by nearly $200 million.
PAHPA currently supports BARDA’s Broad Spectrum Antimicrobials program, though it is not enough to revitalize the antibiotic pipeline.
• Committee staff are considering adding the EIS loan repayment proposal to the bill before it is considered by the full Senate.
• The House Energy and Commerce Committee is expected to release and vote upon its PAHPA reauthorization bill in June. Committee staff have expressed support for including the EIS loan repayment proposal.
• Representatives Bilirakis (R-FL) and Schakowsky (D-IL) are championing the EIS loan repayment proposal and urging its inclusion in PAHPA reauthorization.