In drug development, there are many different kinds of market and business challenges. When those challenges place our nation’s health security at risk, the U.S. government must step up with critical leadership as well as financial and technical support to counter the forces that prevent the development of desired drugs such as antibiotics. Enter: BARDA.

At BARDA, we spur innovation, support development of medical countermeasures (which include drugs, vaccines, and diagnostics) to enhance national preparedness for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases, and in some cases purchase such countermeasures for the Strategic National Stockpile. We have also partnered with industry to enhance our manufacturing infrastructure to produce needed medical countermeasures rapidly in the event of an emergency.

There is no market other than the government for medical countermeasures against threats such as anthrax and smallpox and the Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 created BARDA to address the resulting gaps in medical countermeasure development. Drawing on authorities granted in PAHPA, the 2013 reauthorization of PAHPA (PAHPRA), and in the Project BioShield Act of 2004, BARDA addresses market and business challenges associated with the development of medical countermeasures for CBRN threats and pandemic influenza.

BARDA provides our industry collaborators with advanced research and development funding, a set of core services to facilitate development and manufacturing, and technical expertise to grow a portfolio of medical countermeasures. The government investment managed by BARDA has delivered significant results in recent years.

• BARDA’s CBRN and pandemic influenza portfolio currently spans more than 150 medical countermeasures.
• BARDA’s CBRN Division has added twelve new CBRN medical countermeasures to the Strategic National Stockpile to prepare our country to respond to a biological threat like smallpox or anthrax.
• BARDA’s Influenza Division has supported the development of several first-in-class vaccines licensed in the U.S., established and maintains a stockpile of vaccines against influenza strains with pandemic potential, and supports the advanced development of novel influenza antiviral drugs, point of care diagnostics and next-generation ventilators.
• Across the CBRN and pandemic influenza portfolio BARDA has provided funding to support the approval/licensure/clearance of 7 new products in the last two years.

BARDA has been successful to date in partnering with industry to address challenges in CBRN and influenza medical countermeasure development because we bring critical and unique resources to the partnership, such as congressional authorization and dedicated funding, flexible appropriations, innovative partnership mechanisms, and a clear mandate.

The progress achieved by our industry partnerships demonstrates that with the right leadership, strategies and appropriate targeted incentives the government can provide a successful response to challenges in the pharmaceutical market.

As described in CDC’s report Antibiotic Resistance Threats in the United States, 2013, our nation is challenged with the growing threat of antibiotic resistance while the antibiotic pipeline responsible for developing new antibiotics has been decreasing over the last 30 years.

 

Figure:  The Antibiotic Development Gap

 

There are many reasons we face this dire situation. Antibiotics are costly to develop, but provide a limited return on investment. Companies have shifted their focus to medicines that are used to treat chronic diseases (e.g. cardiovascular, diabetes, depression) over many years, since these medicines will bring larger and more reliable returns than antimicrobials, which are taken for much shorter periods and may lose their effectiveness as resistance rates increase. Simultaneously, as antibiotic resistance rates have risen, there has been greater pressure on healthcare providers to limit the use of new antibiotics and only prescribe/use these lifesaving drugs when truly needed. Antibiotic stewardship programs, while necessary to limit the emergence of resistance, further weaken the business case for continuing antibacterial development.

These negative market factors have been building and, today, the world is at a critical point. The number of new antibiotics coming to market has declined steadily for decades because of these technical and business challenges at the same time we are experiencing a surge in antibiotic resistance worldwide.

BARDA is working hard to reverse this decline. In 2010, BARDA established a Broad Spectrum Antimicrobials (BSA) Program to focus on developing novel antibiotics to address biological threats as well as the public health threat of antibiotic resistance. In four years, the BARDA program has grown from supporting one industry partnership with an antibiotic candidate in Phase 2 development to six partnerships with three of our industry partners in Phase 3 clinical development.

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 the CBRN and influenza market failures. Dedicated funding for antibiotic development, flexible appropriations, continued ability to enter into innovative partnerships, and a clear mandate will ensure BARDA can help our nation combat these threats.

If we are to overcome the threat of antibiotic resistance, then the nation must respond with similar determination, conviction and resources as we have with other market challenges. At BARDA we are ready to respond to this evolving threat and we’ll need the assistance of individuals, organizations and industry.

This post is the second part in our series Combatting Antibiotic Resistance. To stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook.