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Thursday, March 14, 2013

Obama expected to sign PAHPRA into law

Medical Countermeasures, U.S. Bioterror Policy: Obama expected to sign PAHPRA into law

President Obama is expected soon to sign the Pandemic and All-Hazards Preparedness Reauthorization Act into law, which will extend for five years the array of federal biodefense programs created following the Sept. 11, 2001, terror attacks.
The U.S. House of Representatives voted 370-28 on March 4 to pass the bill, which came five days after the Senate passed the same bill by a unanimous vote. While President Obama is expected to sign the bill, it will be unclear how closely future funding will meet PAHPRA objectives until the president submits a budget for financial year 2014, 
The law requires Department of Health and Human Services Secretary Kathleen Sebelius to facilitate written management plans to govern the development and regulatory review of medical countermeasures.
“The regulatory management plans help solidify the process for figuring out how to get new medical countermeasures through the FDA (U.S. Food and Drug Administration) and into the stockpile,” Phyllis Arthur, the senior director of vaccines, immunotherapeutics and diagnostics policy for the Biotechnology Industry Organization, said,  “Working with sponsors to develop these unique clinical studies and identify appropriate animal models will better enable the FDA and sponsors to make scientific decisions and hopefully expedite the regulatory process.”
Arthur said that sponsors would have the opportunity to work with the FDA and the Biodefense Advanced Research and Development Authority (BARDA) to develop clinical studies, identify proper animal models and determine milestones in the absence of human efficacy trials to ensure that the products will be effective in case of an emergency.
PAHPRA also reauthorizes the federal special reserve fund to purchase medical countermeasures, extends from eight to 10 years the time during which a security countermeasures should qualify for licensing or approval in Project BioShield and creates a National Advisory Committee on Children and Disasters.

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