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In testimony right before Congress, James Swire, an AIDS activist and well being educator who became infected with HIV in 1990, mentioned the FDA has considerably lessened some time required to approve daily life-preserving medication utilizing the income from PDUFA.

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Broadened consumer fee scope to incorporate article-sector activities together with confirmatory trials and labeling changes [Sec 102]

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PDUFA was at first meant to be a Resource to scale back a growing backlog of drug apps, as well as the 5-12 months sunset as a system to ensure the legislation effectively in realized that objective. The next PDUFA reauthorizations, nonetheless, have developed to include more legislation which has profoundly reshaped the FDA’s rules and authority. Congress could have instituted these changes on the FDA absent PDUFA, but the consumer rate reauthorization cycle provides marketplace a novel opportunity to obtain its legislative plans.

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"We continue on to obtain problems with The truth that accredited medicines in other international locations are not able to get authorized in this article. But what I particularly can not recognize in the least are situations in which you have people struggling terminal health problems, and they can not have the experimental drugs that might save their life."[eight]

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