Government must take action to protect Americans from 21st century health threats

Government must take action to protect Americans from 21st century health threats
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The United States continues to face significant health security threats — from the bioterrorism threats posed by ISIS and North Korea to natural threats from pandemic influenza and antibiotic resistant bacteria (better known as “superbugs”).

Significant progress has been made to build the right structure, partnerships, and products needed to save lives and protect Americans from many of these threats. Yet for all the ground that has been gained, more is needed to fully protect our country.

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The U.S. government has a proven structure in place through which federal agencies collaborate to move products from discovery to the market or stockpile and prioritize which products agencies will pursue.

 

The U.S. Department of Health and Human Services partners with innovative researchers and companies to develop and stockpile medical countermeasures, such as vaccines, medicines, and diagnostic tests, to protect the public from health security threats. The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS office of the assistant secretary for Preparedness and Response or ASPR, has created an innovative partnership model to overcome the challenges inherent in developing medical products needed to save lives in public health emergencies.

BARDA invests in medical countermeasures that protect civilians, particularly in products for which a commercial market usually does not exist. BARDA partners with companies and provides stable development and procurement funding, usually cost-sharing, and technical assistance to bridge the so-called “valley of death” between early and advanced stages of product development where such medical countermeasures historically have languished for a variety of reasons.

Over the past decade, BARDA and its private sector partners have shepherded 34 products through development to receive approval by the Food and Drug Administration.

These products include new vaccines, drugs, diagnostics and medical devices. Under the ground-breaking Project BioShield program, BARDA has supported 27 products to protect against potential intentional national security threats; 14 of these have been delivered to the nation’s Strategic National Stockpile and are ready for use in an emergency. 

Neither the government nor private industry could have achieved these accomplishments without working together. These efforts have increased America’s preparedness dramatically.  

While we have built real capabilities to combat the serious threats we face, there is more to be done to combat evolving threats. We must improve our capability to develop, manufacture, assess, and use medical countermeasures rapidly in the face of an emerging threat so that the right countermeasure is available in the right place and at the right time to minimize the health effects of the crisis. We must develop technology that can transition quickly between products to help avert a catastrophe. Partnering on cutting-edge technologies for use in an emergency can be a tough sell to private industry, although BARDA has shown that public-private partnerships can be mutually beneficial.

Working with partners in the biopharmaceutical industry and within the U.S. government, BARDA will continue to support the development of products and platform technology that can be used to counter any pathogen — the ones we know about and the new ones that quickly emerge. BARDA will leverage its partnership model to make the most of its funds and decrease the time needed to identify, produce and make available the countermeasures essential to saving lives.

Responding to 21st century threats requires sustained funding as well as innovative development and partnership models. Success requires that government and industry continue to join forces.

BARDA is committed to evolving its business practices to meet the constantly changing technological landscapes and threat space while also sustaining the hard-won gains of the past ten years.

Maintaining industry confidence in the federal government as a reliable, value-added partner requires sufficient, multi-year funding. While threats evolve, the mission remains constant: Ensure the right medical countermeasures are available when and where we need them to save lives and protect Americans.

Robert Kadlec, M.D. is the U.S. Department of Health and Human Services assistant secretary for preparedness and response. Rick Bright, Ph.D. is the director of HHS/ASPR biomedical advanced research and development authority.