WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) lauds the Senate for passing H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), yesterday by a unanimous vote.
“The bipartisan legislation provides needed clarity for the regulatory process for medical countermeasures at the Food and Drug Administration and strongly encourages the Agency to work with product sponsors to develop regulatory management plans, provide technical assistance and help solve regulatory and scientific issues.”
BIO commends Chairman Tom Harkin (D-IA), Sen. Richard M. Burr (R-NC), Sen. Mike Enzi (R-WY), Sen. Bob Casey (D-PA), and Ranking Member Lamar Alexander (R-TN) for their leadership on this important issue.
Below is a statement from BIO’s President and CEO, Jim Greenwood:
“We applaud the Senate for its commitment to improving our nation’s capacity to prepare and respond to natural disasters, bioterrorist attacks, and outbreaks of infectious disease. PAHPRA enables the frontline response of the public health and healthcare systems, rather than funding on an emergency-by-emergency basis.
“The bipartisan legislation provides needed clarity for the regulatory process for medical countermeasures at the Food and Drug Administration and strongly encourages the Agency to work with product sponsors to develop regulatory management plans, provide technical assistance and help solve regulatory and scientific issues.
“These provisions will help provide transparency and consistency to accelerate the development and approval of medical countermeasures (MCM).
“The reauthorization of PAHPA signifies the solid commitment of government attention and funding, which will allow the biotech industry to do even more to help protect our nation.
“Biotech companies are willing and active partners in the national security endeavor. Our industry plays a central role in ensuring the effective development of MCMs to protect our nation’s citizens against chemical, biological, radiological and nuclear threats, whether naturally occurring or man-made.
“Strengthening the pipeline of medical products, drugs and devices that will safeguard the nation during an emergency or pandemic is vital to our national security.”
"BIO strongly encourages the House of Representatives to consider this important measure in the near future."
A similar version of this bill was previously passed by the House of Representatives, and the Senate bill will now go to the House for a final vote.
More information on PAHPA can be found at http://www.bio.org/category/vaccines-biodefense.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtechNOW, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtechNOW.
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