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Congress Passes Pandemic Act, Extending Funding for Project Bioshield and BARDA

NEW YORK (GenomeWeb News) – The US House of Representatives and the Senate have passed the Pandemic All Hazards Preparedness Reauthorization Act of 2013, which will provide several billion dollars for development and stockpiling of medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) attacks.

The bill cleared both the House and Senate with overwhelming support over the past few days and has now been submitted to the White House.

The act reauthorizes the Pandemic All Hazards Preparedness Act of 2006 for another five years, extending funding for Project Bioshield, for the Biomedical Advanced Research and Development Authority (BARDA) program, and enacts initiatives to speed development of medical countermeasures.

These pandemic preparedness initiatives began in 2004 when Project Bioshield was launched to create new and more flexible authorities and funding for developing and procuring medical countermeasures. These programs are overseen by the Department of Health and Human Services' Assistant Secretary for Preparedness and Response.

The programs expanded with the 2006 passage of the first PAHPA, which created BARDA to streamline the MCM approval process and to provide flexible funding for research and development into new countermeasures and platform technologies.

The new act authorizes $415 million per year to fund BARDA between 2014 and 2018, the same annual rate as it received this year. The total cost of BARDA over the next five years would be around $1.6 billion, the CBO estimated.

This five-year reauthorization also will provide $2.8 billion for Project Bioshield, effectively providing the same dollar amount it has been authorized over the last 10 years, during which it received $5.6 billion, according to the Congressional Budget Office. It will support the Special Reserve Fund, which is used to fund contracts for research and development into and stockpiling of medical countermeasures.

Since its 2004 launch the SRF has been used to award nine contracts totaling over $2 billion for the development and acquisition of medical countermeasures, leading to the stockpiling of 17 countermeasures against six threats, according to HHS. This reauthorization will enable up to 50 percent of the SRF to be used to fund research and development of medical countermeasures, with the other half marked for procurement and stockpiling activities.

Eighty other candidate MCMs are currently undergoing advanced development, and eight have been procured for protecting against anthrax, smallpox, botulinum toxin, and radiological threats, the Biotechnology Industry Organization, which strongly supports the act, said in a recent policy brief.

The reauthorization also extends the time period during which security countermeasures can qualify for approval, licensing, and for contracts under Bioshield from eight to 10 years.

It also gives the FDA the ability to extend the expiration date for MCMs, grant waivers of good manufacturing practices, waive a product's risk-mitigation strategy, and authorize the dispensing of MCMs during an emergency without the need for an individual prescription.

In an effort to facilitate the approval, clearance, and licensing process, the act also requires that FDA establish a process for receiving frequent scientific feedback and interaction with developers whose MCMs have been procured through the Special Reserve Fund.

According to the CBO, the renewed legislation will cost a total of $11 billion between 2014 and 2018.

The bill passed the House on Monday on a vote of 370 to 28, and cleared the Senate on Feb. 27 with unanimous consent.

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