This is granted when a drug is intended to treat a serious condition and would "provide a significant improvement in safety or effectiveness" over currently available treatments.
[2] In 2007, Title XI of the Food and Drug Administration Amendments Act of 2007 created the priority review voucher program for neglected tropical diseases.
This was extended in 2012 by the Food and Drug Administration Safety and Innovation Act to include rare pediatric diseases.
[citation needed] Prior to approval, each drug marketed in the United States must go through a detailed FDA review process.
The 2002 amendments to PDUFA set a goal that a standard review of a new drug application be accomplished within a ten-month time frame.
The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment.
Such advances can be demonstrated by, for example: evidence of increased effectiveness in treatment, prevention, or diagnosis of disease; elimination or substantial reduction of a treatment-limiting drug reaction; documented enhancement of patient willingness or ability to take the drug according to the required schedule and dose; or evidence of safety and effectiveness in a new subpopulation, such as children.
FDA determines within 45 days of the drug company's request whether a priority or standard review designation will be assigned.
The additional user fee also aims to ensure that the new program will not slow the progress of other products awaiting FDA review.
In 2012, President Obama signed into law the FDA Safety and Innovation Act which includes Section 908, the "Rare Pediatric Disease Priority Review Voucher Incentive Program".
[22] In December 2014, the Senate approved a bill that would add the Ebola virus to the Priority Review Voucher List.
[23] The bill, S. 2917—Adding Ebola to the FDA Priority Review Voucher Program Act, was introduced by Senator Tom Harkin on November 12, 2014.
[26] The Senate's Medical Countermeasure Innovation Act of 2016 proposed adding a new category of drugs to the priority review voucher program.
Medical countermeasures are drugs to "prevent or treat harm from a biological, chemical, radiological or nuclear agent identified as a material threat".
[27] Writing in The Lancet, David Ridley and Alfonso Calles Sánchez proposed extending the voucher to the European Union.
[29] A 2015 Wall Street Journal article raised concerns about the sale of these vouchers, given that they "require the FDA to shorten its decision deadline to six months from the standard 10 months—potentially giving companies an extra four months' worth of sales," but also noted that a voucher is not a guarantee of FDA approval for a drug.
[30] In 2014, Regeneron Pharmaceuticals and Sanofi purchased a PRV that BioMarin had won for a recent rare disease drug approval for $67.5 million; the voucher cut four months off the regulatory review time for alirocumab and was part of their strategy to beat Amgen to market with the first approval of a PCSK9 inhibitor.
Aidan Hollis of the University of Calgary has commented that the proposal does not address "the access problem, but helps to increase incentives through creating distortions in markets in developed countries".
[citation needed] According to Bill Gates,[38] "Some of the highest-leverage work that government can do is to set policy and disburse funds in ways that create market incentives for business activity that improves the lives of the poor.