Pharmaceuticals Regulation

Do priority review vouchers actually speed up the FDA approval process

The priority drug review process was enacted in 2012 in order to stimulate drug development for rare pediatric diseases. Drugs granted priority review had the typical ten-month FDA review timeline shortened to 6 months. For a drug to be eligible for this program, it must not only be for a rare disease but it must demonstrate significant improvement in safety or efficacy compared to the status quo. Pharmaceutical firms can also sell the voucher to other firms or transfer it to another rare disease product if they would like.

The question is, does this actually speed up the drug review process. According to a paper by Hwang et al. (2019), the answer is ‘yes’.

Times to progression to the next stage of development were shorter among drugs eligible for a pediatric PRV, compared to ineligible drugs for rare adult diseases, across all three phases of clinical development. As of April 1, 2018, the estimated percentage of eligible versus ineligible drugs that had successfully progressed to the next stage of development at thirty-six months was 68 percent (95% CI: 57, 79) versus 51 percent (95% CI: 46, 56) in Phase I, 36 percent (95% CI: 23, 53) versus 27 percent (95% CI: 21, 34) in Phase II, and 41 percent (95% CI: 22, 68)

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