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Posted 14 July 2016 | By Zachary Brennan
The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset.
The new PRVs for medical countermeasures, if passed by the full House and Senate, would be the third PRV program in existence (in addition to the rare pediatric disease and neglected tropical disease PRV programs) and the first to not sunset.
Like the other two PRV programs, HR 3299 would grant companies that receive approval for such a countermeasure access to a PRV that can then be either sold on the open market (AbbVie bought one in August 2015 for $350 million) or used to expedite the US Food and Drug Administration’s (FDA) review of the countermeasure’s sponsor’s own new drug by four months.
Medical countermeasures that might earn their sponsor such a PRV include new drugs to prevent, or treat harm from a biological, chemical, radiological or nuclear agent identified as a material threat, according to the bill, which passed 36-15 following the rejection of two amendments that would ensure the program sunsets.
Much of the late night discussion on the bill ahead of its advancement to the House floor centered around when to sunset the new PRV program (to ensure it is working before it is re-authorized, like with the rare pediatric PRV program).
Rep. Jan Schakowsky (D-IL) raised some questions, echoing similar sentiments raised by FDA and other researchers, about the effectiveness of PRVs in incentivizing new drug development.
Rep. Anna Eshoo (D-CA), however, was adamant that because it can take more than a decade to develop new medical countermeasures and because the federal government is the only purchaser of these treatments, this PRV program should not sunset.
Rep. Chris Collins (R-NY) also said ending the new PRV program on a specific date could create ambiguity and diminish the appeal of PRVs.
But what was not mentioned was the fact that the addition of a new PRV program and the potential circulation of new PRVs on the open market could have a significant impact on the price that PRVs in the other two programs are purchased for, and therefore the incentives that all three of the programs would provide to develop new treatments.
Doctors Without Borders/Médecins Sans Frontières (MSF) added in a statement that the PRV program needs to be further reformed so as not to “leave open major loopholes in the program.” Biosimilar and vaccine developer Pfenex said it supports the PRV provision in the bill to further encourage the development of medical countermeasures for the 13 deadly pathogens identified by the Department of Homeland Security as national security threats.
The new medical countermeasure PRV program in the bill would also establish a new user fee program under which a sponsor of a drug application that is the subject of a priority review voucher shall pay to FDA, in addition to other fees required to be submitted by the sponsor.
In addition to creating the new PRV program, the medical countermeasure bill would also require the sponsor of the medical countermeasure to offer a report no more than five years after the product's approval. The Comptroller General of the US would also have to conduct a study on the effectiveness of such PRVs and how they are incentivizing the development of material threat medical countermeasure applications.
In general, the bill also seeks to establish a more predicatable and transparent method of resourcing and procuring medical countermeasures by the government.
The new text of the bill comes as G.K. Butterfield’s (D-NC) amendment to HR 3299, which sought to reform the other PRV programs, was cut out of the bill’s text.
Tags: PRV, priority review voucher, FDA priority review, user fees for priority drug reviews