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U.S. Department of Health and Human Services

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Protecting antibiotics by strengthening the antibiotic pipeline

Author: Dr. Melissa Stundick, Acting Branch Chief Broad Spectrum Antimicrobials Program, Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services
Published Date: 11/25/2014 12:11:00 PM
Category: Medical Countermeasures;

Every day, we rely on antibiotics to stay healthy – and having effective antibiotics is even more critical to help treat bacterial disease during a disaster or infectious disease outbreak caused by bacteria. Though we know that disasters will strike again and disease outbreaks will continue to happen, we can’t be sure that the antibiotics that we rely on will continue to be effective in fighting bacterial infections.

The antibiotic pipeline responsible for developing new antibiotics has been crumbling over the last 30 years. Antibiotics are costly to develop so many companies have shifted their focus to medicines to treat chronic diseases, since these medicines bring larger and more reliable returns on their investments than antibiotics.

To reverse the decline of the antibiotic pipeline, we need a strategy for creating a market, promoting public-private partnerships, and providing funding. The White House has recently put a series of plans and strategies in place to support those objectives.

On September 18, 2014, President Obama signed an Executive Order on Combating Antibiotic Resistant Bacteria. The Executive Order expanded BARDA’s authority to develop new and next generation countermeasures that target antibiotic-resistant bacteria that present a serious threat to public health. This allows BARDA to use its resources more efficiently and increases the breadth of technological solutions we can bring to bear.

As one example of how these new authorities can be used, BARDA can now support narrow spectrum or pathogen-specific products such as monoclonal antibodies against Pseudomonas aeruginosa. This infection strikes patients in hospitals, especially those on breathing machines, using devices such as catheters, with wounds from surgery, or with wounds from burns. In the wake of a major disease outbreak, hospitals rely on these devices for patient care, thus increasing risk of Pseudomonas aeruginosa. In a disaster that involves an increased number of injuries and burn victims, you would also expect to see increased instances of Pseudomonas aeruginosa. By finding a way to combat this disease, BARDA is supporting an all-hazards medical response.

The National Strategy for Combatting Antibiotic Resistant Bacteria was created, in part, help find a solution that creates the required business case for additional antibiotic development. The national strategy called for the expansion of opportunities for public-private partnerships like those already active within the Broad Spectrum Antimicrobials (BSA) Program as well as the establishment of a biopharm incubator to accelerate research on new antibiotics and other tools to combat resistant bacteria. Public-private partnerships are the foundation of the BSA program and have been used successfully to date to engage companies developing novel antibacterial therapeutics.

In their Report the President on Combatting Antibiotic Resistance, the Presidential Council of Advisors on Science and Technology (PCAST) recommended that BARDA receive $400 million in advanced research development funding annually. In addition, the report recommended that an Antibiotic Incentive Fund be established at a funding level of $4 billion over ten years. The fund would be used to incentivize companies developing antibiotics thru milestone payments; advance market commitments; and reimburse late stage development or post marketing commitments. Legislative action will be needed to enact any of these recommendations.

Reversing the decline in antibacterial drug development will require a response similar to the one BARDA and the rest of the U.S. government used to overcome market failures in combating influenza and chemical, biological, radiological and nuclear threats to our nation’s health security. Dedicated funding for antibiotic development, flexible appropriations, the continued ability to enter into innovative partnerships, and a clear mandate will better enable BARDA to help our nation combat these threats. 

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