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For A Chance at Better Health Outcomes, the Time to Act is Now

The Prescription Drug User Fee Act (PDUFA) is an important law that most people have never heard of. Why is it important? It provides the U.S. Food and Drug Administration (FDA) with resources it needs to ensure drugs are promptly reviewed and made available to patients in a timely manner. The latest version of the Act is up for reauthorization this year – as it has been every five years – and it is just as critical as ever that Congress renews and strengthens it.

Before PDUFA was passed in 1992, it took the FDA an average of two-and-a-half years to approve new drugs.1 Since this law was enacted, the average review time for new medicines has declined to less than 11 months2 and has helped bring over 1,500 safe, new and effective medications to patients.3 And nearly 84 percent of all medicines in the world are first approved in the United States.4 If Congress doesn’t reauthorize PDUFA, we risk going back to patients having to wait longer for the medicines they urgently need.

Reauthorizing PDUFA will also make it stronger. The updated version of the Act enhances FDA’s capacity to review clinical trials by using evidence-based research in new, innovative ways. This will advance how clinical trials are developed and modernize outdated practices that temper innovation. The updated version of the law also streamlines hiring practices to enable FDA to recruit and retain world-class scientists in staff positions that are crucial to the FDA’s ability to best serve patients.

Congress has until September 30, 2017, to vote to reauthorize and improve PDUFA. There is too much at stake to dial back the progress we have made over the past 25 years.

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1http://www.phrma.org/advocacy/research-development/pdufa and https://object.cato.org/sites/cato.org/files/serials/files/regulation/2002/4/v25n1-2.pdf

2http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM533192.pdf

3https://www.fda.gov/NewsEvents/Testimony/ucm289029.htm and http://www.phrma.org/advocacy/research-development/pdufa

4http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM533192.pdf