Regulatory Focus™ > News Articles > Report: FDA Meeting Review Goals Under PDUFA

Report: FDA Meeting Review Goals Under PDUFA

Posted 01 May 2012 | By Alexander Gaffney, RAC 

The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA).

GAO's report to Congress notes FDA has generally "met performance goals for priority and standard New Drug Applications (NDAs) and Biologic License Applications (BLAs) received from Fiscal Year (FY) 2000 through FY 2010."

FDA met its performance goals for NDA and BLA reviews every year except for 2008, said GAO, and appears to be on pace to do so again in 2011.

GAO did take note of industry concerns in its report, including the oft-discussed differences between so-called "FDA-time" and the time it takes for a product to actually get to market. Actions and requirements by FDA can often stop the review clock while still meeting PDUFA review goals, noted GAO.

"Overall, average FDA review time-the time elapsed from when FDA received a submission until it issued an action letter-increased slightly from FY 2000 through FY 2010 for both priority and standard NDAs and BLAs," wrote GAO, alluding to this point.

Some of this increase was attributable to the passage of Food and Drug Administration Amendments Act (FDAAA) and its Risk Evaluation and Mitigation Strategy (REMS) provisions, which GAO noted was likely behind FDA's inability to meet performance goals in 2008. REMS plans are mandated by FDA to ensure the safe use of an otherwise risky product.

Review times, which had averaged around 200 calendar days per review, briefly spiked at around 250 days per review before slowly coming down to normal levels in subsequent years.

GAO's report also highlighted the increased use of priority reviews for NDAs and BLA's since 2001, but noted this trend had reversed since 2007, when it peaked at roughly 70%. In 2010, roughly 50% of submissions were approved by FDA in a first-cycle priority review.

"Insufficient communication between FDA and stakeholders throughout the review process" was also cited by GAO as a contributing factor to increased industry frustration, as was review consistency and predictability.

Safety advocates, too, expressed consternation with FDA's review procedures in GAO's report, calling attention to "inadequate assurance of the safety and effectiveness of approved drugs."

The US Department of Health and Human Services, the parent agency of FDA, said in a statement provided to GAO that they generally agreed with the sentiments of the report, and added that FDA has taken steps to "improve the prescription drug review process."


Read more:

GAO - FDA Has Met Most Performance Goals for Reviewing Applications

GAO: Prescription Drugs - FDA Has Met Most Performance Goals for Reviewing Applications (Report)

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