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CLSA Wire

Congressional Committee Advances Measure to Improve Biodefense R&D Infrastructure
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July 18, 2016

CLSA strongly supports H.R. 3299, the Strengthening Public Health Emergency Response Act, legislation that would make important improvements to ensure our nation’s biodefense infrastructure is adequately prepared in the event of a bioterrorism or pandemic outbreak. Specifically, the legislation creates a priority review voucher (PRV) program at the U.S. Food and Drug Administration (FDA) to incentivize the research, development, and licensure of medical countermeasures in a space where no commercial application exists for these products.

In collaboration with our membership and the bill’s sponsors, Representatives Anna G. Eshoo (D-Silicon Valley) and Susan Brooks (R-Ind.), CLSA has worked to bolster support for the legislation. The bill currently enjoys support from 47 cosponsors, including 10 from the California congressional delegation: Reps. Tony Cárdenas (D-Van Nuys), Jeff Denham (R-Modesto), John Garamendi (D-Davis), Duncan Hunter (R-El Cajon), Steve Knight (R-Simi Valley), Devin Nunes (R-Fresno), Jackie Speier (D-San Mateo), Eric Swalwell (D-East Bay), Juan Vargas (D-Chula Vista), and Mimi Walters (R-Irvine).

Last week, the House Energy and Commerce Committee passed H.R. 3299, by a vote of 36 to 15. California delegation members voting in favor of the legislation included Reps. Cárdenas, Eshoo, Doris Matsui (D-Sacramento), and Jerry McNerney (D-Stockton). Our delegation’s other committee member, Rep. Lois Capps (D-Santa Barbara), was not present and did not vote on final passage or any amendments. CLSA’s endorsement letter of support for the version of the bill considered at markup (in the form of a bipartisan compromise amendment in the nature of a substitute (AINS) for H.R. 3299 is available here.

Three minority amendments were offered during the course of debate on the underlying bill, none of which were ultimately adopted by the committee:

  • Frank Pallone (D-NJ) – An amendment stripping the bill of the provision to move MCM contracting at HHS to BARDA: Rep. Eshoo spoke passionately about the need for contracting authority to be returned to BARDA in order to increase efficiency in the research and development of medical countermeasures (MCMs), a recommendation echoed by the Bipartisan Report of the Blue Ribbon Study Panel on Biodefense released in October 2015. This amendment failed on voice vote.
  • Frank Pallone (D-NJ) – An amendment that would institute a 7-year sunset to the MCM Priority Review Voucher (PRV) program: Again, Rep. Eshoo spoke against this amendment as counterintuitive when therapies often take more than 10 years to develop, a sunset provision of 7 years would greatly undermine the legislation. The amendment failed by a vote of 14 to 38. California delegation Reps. Eshoo, Matsui, McNerney and Cárdenas voted no on the amendment.
  • Lois Capps (D-Santa Barbara) – An amendment that would institute a 12-year sunset to the MCM Priority Review Voucher (PRV) program:Rep. Gene Green (D-Texas) offered the amendment on Rep. Capps’ behalf. Similar to the sunset provision offered by Ranking Member Pallone, the amendment failed by a vote of 18 to 34. California delegation Reps. Eshoo, Matsui and Cárdenas voted no on this amendment.

The bill will next be considered by the full House of Representatives after the August Recess. Additionally, this week, Sen. Richard Burr (R-N.C.) “hotlined” the Senate companion legislation for this bill (S. 2055, the Medical Countermeasure Innovation Act). Action on both the House and Senate measures is expected after Congress returns from its summer work period in September.

CLSA will continue our work to advance this legislation, and advocate on behalf of policies that spur the research and development of medical countermeasures to ensure our nation’s pandemic preparedness.