To Improve Pandemic Preparedness, Update The Priority Review Voucher Program

Legislation recently introduced in the U.S. House of Representatives would add the Zika virus to the list of diseases in the Food and Drug Administration’s (FDA) priority review voucher (PRV) program. The Senate HELP Committee has also recently advanced similar legislation. This is a positive step that would help incentivize needed research and development (R&D) to fight the disease. However, it also illustrates the fact that the PRV platform could be used far more proactively to help address future pandemics before they strike. Incentive For Innovation In 2007 the US government created the PRV as an incentive to drive research into neglected diseases which typically don’t command big commercial markets. Under the program, companies that successfully develop and receive FDA approval for a drug that treats a disease on the PRV list then earn a voucher that entitles them to expedited review for another more commercially promising product. The logic is that the potential value of shortened time to market for a profit-making drug is a significant enough incentive to drive research into diseases that would otherwise not attract enough R&D attention. The voucher can be used by the company that earns it, or sold to another company at a negotiated price. The PRV model is not perfect; there is space to improve the effectiveness and impact of the program, and other research and access incentive mechanisms are worth exploring. Nevertheless, the PRV model has already shown so...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Technology Featured Global Health Congress Ebola FDA outbreaks pandemic priority review Research Zika Source Type: blogs