Abstract
FDA officials do not support continuing the pediatric voucher program, scheduled to expire on Oct. 1. Created in 2012, the program is meant to incentivize the development of drugs against rare pediatric diseases. A similar program targeting neglected tropical diseases dates back to 2007. Awarded by FDA upon a drug’s approval, these vouchers can be used on another product to shorten regulatory review to six months—a 40% reduction. If the awardee doesn’t need the voucher, it can sell it, which has occurred five times. In 2015, United Therapeutics reaped a record $350 million when it sold one to AbbVie. FDA made its opinion known in comments to the Government Accountability Office, which spent eight months studying the effectiveness of the pediatric plan and recently released its report. FDA told GAO that it has seen “no evidence that the program has encouraged increased development of drugs for rare pediatric diseases.” FDA
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