Regulatory Focus™ > News Articles > 8 > FDA Researchers Find PRV Program Stimulates Tropical Disease R&D

FDA Researchers Find PRV Program Stimulates Tropical Disease R&D

Posted 10 August 2018 | By Zachary Brennan 

FDA Researchers Find PRV Program Stimulates Tropical Disease R&D

Three US Food and Drug Administration (FDA) researchers found a significant increase in the development of new tropical disease drugs after Congress enacted priority review voucher (PRV) legislation, according to a study published in PLOS Thursday.

Despite the new investments, the researchers found that the effects of the PRV program are not uniform across all tropical diseases, as malaria and tuberculosis “have seen significant new drug development, while other diseases have not.”

Beginning in 2009, which is the year that the first PRV was awarded, the researchers saw a spike in investment in tropical disease treatments. In 2016, they also found “a large increase in initial development” as this was the year after multiple PRVs sold for hundreds of millions of dollars.

“Companies may have seen the high sale prices of the vouchers and decided to enter the tropical disease space,” researchers said.

But because development failure rates remain high and the cost of PRVs on the open market has steadily declined, companies may determine that the cost of development is not worth the potential prize. In such cases, they predict that drug development may return to pre-PRV levels. 

For more on PRVs, see the Focus explainer.

PLOS
 

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe