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# Benefits of Pediatric Voucher Program Unclear
- URL: https://www.fdaweb.com/benefits-of-pediatric-voucher-program-unclear/
- Published: 2016-03-02T12:00:00.000Z
- Updated: 2026-09-15T02:40:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134944

> The Government Accountability Office (GAO) says it is too early to determine whether the FDA pediatric voucher program has stimulated development of drugs to treat or prevent rare pediatric diseases. Since drug development time often takes a decade, the GAO [report](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTYwMzAyLjU1OTQ0NTkxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDMwMi41NTk0NDU5MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MDE3MzEzJmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.gao.gov/products/GAO-16-319?utm%5Fmedium=email&utm%5Fsource=govdelivery) says, insufficient time has elapsed to determine whether the three-year-old program has been effective.  
>  
> The report notes that as of 12/31/15 there have been 11 requests for a pediatric voucher. Six have been awarded, two were denied, and three are still under review. GAO says that the six drugs for which vouchers were awarded were in development before the program was implemented and helped fulfill unmet medical needs. Four of the six awarded pediatric vouchers were sold to other drug sponsors for prices ranging from $67.5 million to $300 million. One of the six vouchers has been redeemed and was used to obtain a priority review of an NDA for a drug to treat adults with high cholesterol.  
>  
> According to GAO, FDA officials said they support the goal of providing incentives for drug development for rare pediatric diseases but have seen no evidence that the program is effective. They note that it is to terminate 10/1 and they do not support its continuation. Agency officials expressed a concern that the program adversely affected their ability to set public health priorities by requiring FDA to provide priority reviews of NDAs that would not otherwise qualify if they do not treat a serious condition or provide a significant improvement in safety or effectiveness. The officials also said that the additional program workload strains the agency’s resources.  
>  
> However, GAO said, other stakeholders provided generally positive feedback on the program.