Tell FDA What to Do: Suggestions Welcome for New Priority Review Voucher Program

The global health community likes to throw around buzz phrases (the 10/90 gap) that point to one reality: inadequate R&D dollars for neglected diseases. While this situation has undoubtedly improved in the last decade, it is still undeniably the case, and it has led economists and others to think about plausible incentive and innovative financing mechanisms to attract industry for greater R&D investment for specific diseases. Research from Harvard economist, and CGD non-resident fellow, Michael Kremer led to the launch of the pilot advance market commitment (AMC) for pneumococcal vaccines in February of 2007, and now, thanks to the work of three Duke economists, there is another new incentive out there to nudge the biopharmaceutical industry in this direction.The Duke research on Priority Review Vouchers (PRV) led Senators Sam Brownback (R-KS) and Sherrod Brown (D-OH) to include it in an amendment to the FDA Revitalization Act of 2007 passed in September of last year. The amendment gives FDA the authority to award a PRV to the sponsor (company/entity) of a newly-approved neglected disease product application. The fully-tradable voucher can then be used to obtain a priority review for another product application. The value of the PRV is found in the significantly faster turnaround time garnered from the priority review, helping that product reach the market several months sooner (and possibly ahead of competitors). When applied to a blockbuster product, this time advantage has been estimated in the hundreds of millions of dollars.Our blog reported on PRVs over a year ago, but now you have the opportunity to guide FDA in their interpretation of the law. Last month, FDA came out with two pieces of information: its draft guidance, outlining its current thinking on how it would interpret and implement the PRV program; and it announced a public hearing to seek input specifically on possible additions to the list of tropical diseases currently covered by the amendment. The hearing will take place on December 12, from 9am-5pm at 429 L’Enfant Plaza, SW, Washington, DC 20594.Comments and suggestions are currently being collected by our colleagues at BIO Ventures for Global Health, who has taken the lead on this through discussions with FDA over the past several months. For more information on PRVs, see the new site they launched today at http://prvinfo.org, and please direct any messages to wtaylor@bvgh.org or rdaly@bvgh.org.