A panel of experts in human and veterinary medicine charged with advising the US government on antibiotic resistance has come up with a set of recommendations to boost development of vaccines, diagnostics, and new therapies that could reduce the spread of antimicrobial resistance (AMR) in humans and animals.
In a draft report that emerged from last week's meeting of the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB), the panel identified the critical issues that hinder development of vaccines, diagnostics, and therapeutics and proposed recommendations to address those challenges.
The group's recommendations focus on encouraging additional public and private funding for research and development, creating new market incentives to encourage pharmaceutical and biotech companies to develop these products, easing regulatory pathways, and educating patients, clinicians, and veterinarians about the potential of these products to minimize and contain AMR in human and animals.
PACCARB was established in 2014 to provide input and policy recommendations to the Department of Health and Human Services on federal programs aimed at combating AMR.
Economic, regulatory barriers
A major focus of the report are the economic barriers that have hampered development of new products to combat antibiotic resistance, barriers that include high development costs, inadequate reimbursement, and an expensive, complex regulatory process.
"On average, the cost of development of a human vaccine or therapeutic ranges from $300 million to more than $1 billion and can take more than 12 years from the start of basic research to delivery to the consumer," the council writes. "A variety of financial and regulatory incentives are needed to address the lack of development of products and undervaluation of existing products to combat antibiotic resistance. Therefore, investment from both public and private entities is required to fill this gap."
Vaccines can address AMR in two ways, either by directly targeting bacterial pathogens that would require antibiotics or by targeting viral pathogens and reducing the likelihood of secondary bacterial infections. But, the council notes, the value of vaccines with respect to AMR is underappreciated.
To properly position vaccines as a component of the response to AMR, the council recommends more data to demonstrate the public health value of new vaccines with respect to AMR, and an expanded range of financial incentives to encourage pharmaceutical companies to focus research and development in this area. The council also recommends more communication from regulatory agencies so that vaccine developers understand what kind of data are needed for the review process.
Diagnostics, which can guide appropriate antibiotic prescribing and reduce the length of hospital stays by identifying levels of drug susceptibility or distinguishing between viral and bacterial infections, face similar challenges. "The cost of development, lack of clinical implementation of approved tests, inadequate reimbursement, and an expensive and complex regulatory process pose barriers to development," the council writes.
To encourage development of new diagnostics tests, the council recommends that a portion of funding for the development of new antibiotics should be dedicated to the production of a concomitant rapid antibiotic susceptibility test for that drug. They also call for sustained investment in funding mechanisms for developing new, cost-effective diagnostic tests, and more clinical and economic outcome studies to assess the clinical utility and cost-effectiveness of these tests.
The council also acknowledges that patient and clinician behavior also impedes greater investment in