Public Health Emergency - Leading a Nation Prepared
Author: Christopher Houchens, PhD, Project Officer, Anti-Infectives Program, ASPR’s Biomedical Advanced Research and Development Authority Published Date: 9/23/2015 6:36:00 AM
Category: Medical Countermeasures;
Can a federal agency engage in long-term strategic partnerships with business? Yes.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA), for instance, is pioneering an innovative approach to collaboration that uses Other Transaction Authority (OTA for short) to create flexible business partnerships between government and industry. Partnerships formed under OTA allow both parties to invest in the development of a portfolio of products for biodefense and to combat the growing public health threat of antibiotic resistance. This approach allows the partners to operate strategically and to proceed even in cases where antibacterial drug candidates fall out during the development process.
The ability of government to enter into such relationships with industry comes at a critical time in the practice of medicine. With the incidence of antibiotic resistance rising, once treatable infections are becoming untreatable and threatening routine medical procedures which depend on available and effective antibiotics.
The CDC estimated that in the U.S alone, antibiotic resistant bacteria are responsible for two million infections and 23,000 deaths annually with an estimated annual economic burden of $35 billion on the healthcare system.
At the same time, the pace of new antibiotic drug development has slowed. Many pharmaceutical companies have been withdrawing from antibacterial R&D due to the significant scientific and commercial market challenges leading to a lower return on investment than in many other therapeutic areas.
With the recent focus on antimicrobial resistance, we’re seeing increased interest from industry in partnering with the government to develop new medical countermeasures – vaccines, drugs, diagnostics and other medical products for emergencies. HHS’ Other Transaction Authority allows for the creation of a strategic alliance between government and industry in which the cost and risk are shared between the two.
In contrast, asset-specific funding – for example a traditional government contract to develop a single drug – lacks the flexibility needed to reposition funds when a drug candidate fails or when public health priorities change.
Both of BARDA’s OTA partners, GlaxoSmithKline and AstraZeneca, have portfolios of potential candidates under development that meet the dual needs of biodefense and antimicrobial resistance. The portfolio approach is a fundamental difference between an agreement and a traditional government contract – and an advantage.
In contrast, a traditional federal contract often requires significant costs and time to modify or close-out if the government terminates a contract (for example, due to product failure) and then award a new contract to develop a new promising drug candidate.
When licensed, the new antibiotics will become available on the commercial market which means not only a return on investment for the company but also a lower long-term cost for taxpayers since less or none of the product would need to be stockpiled by the government.
There’s quite a bit of support behind this approach. The 2015 President’s National Action Plan for Combating Antibiotic-Resistant Bacteria called for forming public-private partnerships with pharmaceutical and biotechnology companies to advance the development of antibiotics through a portfolio approach. This plan specifically called on BARDA to create at least one additional portfolio partnership with a pharmaceutical or biotechnology company by March 2016.
Although we’ve met the 2015 President’s National Action Plan for Combating Antibiotic-Resistant Bacteria goal of forming public-private partnerships with industry with the new AstraZeneca agreement, we’re always looking for solid partners.
Other federal plans call for innovative approaches for partnering with industry, too, including the strategic plan from the Public Health Emergency Medical Countermeasure Enterprise (a coordinating body with members from BARDA, NIH, DoD, VA, FDA, and CDC), the National Health Security Strategy and the BARDA Strategic Plan.
That’s because partnerships – whether they’re under OTA or other cost-sharing agreements – reduce the risk and burden for everyone in developing the broad spectrum antimicrobials urgently needed to counter antibiotic resistance.
Forming public-private partnerships under OTA is a unique way to ensure that the public has, and will continue to have, treatment options for biodefense and to combat the growing threat of multi-drug resistant bacterial infections.
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