FDA Has Met Most PDUFA Performance Goals

Beating up on the FDA over its progress for reviewing drugs is something of a sport among many drugmakers and some members of Congress. And so, a couple of agency critics asked the US Government Accountability Office to do a temperature reading. What did the GAO find? The FDA met most performance goals for priority and standard New Drug Applications and Biologics License Applications that were received from Fiscal Year 2000 through Fiscal Year 2010.

Of course, progress ebbs and flows. In a report released this week, the GAO writes that the average FDA review time increased slightly during this period for both priority and standard NDAs and BLAs. The percentage of FDA first-cycle approvals for both priority and standard NDAs and BLAs generally increased from FY 2000 through FY 2010; however, the percentage of first-cycle approvals has decreased for priority NDAs and BLAs since FY 2007.

Specifically, for priority original and completed standard NDAs and BLAs, the FDA met performance goals for 10 of the 11 years, but failed to do so in fiscal year 2008 (the goal is to issue a specified proportion of action letters within certain timeframes). Why? One likely reason was extra time required for implementing REMS requirements. Meanwhile, the GAO adds the FDA was on track to meet goals for fiscal year 2011.

The report was sent to Senators Richard Burr and Tom Coburn, Republicans from North Carolina and Oklahoma, respectively. Burr, you may recall, threatened to delay passage of PDUFA V unless the FDA speeds approval times for product applications (see here) and introduced legislation to ease conflict of interest rules for FDA advisory committees (read this). Last year, he engineered an amendment to the FDA appropriations bill to require more info about approval times.

How did the senators react? We have asked for comment and will update you accordingly. [UPDATE: A spokeswoman for Burr sent us this: "The report...on drugs released earlier this week underscore(s) the importance of consistent oversight by Congress. America’s patients deserve access to the latest, most effective life-saving treatments, and meaningful congressional oversight will help ensure timely decisions on behalf of our patients.”]

Was Burr chastened? This much is not clear. In any event, there is a lot of data in the report, which you can read here, and there are some other nuggets worth noting. For instance, an average of 44 percent of all original NDAs and BLAs submitted in fiscal years 2000 through 2010 were approved during the first review cycle, and 75 percent were ultimately approved.

The FDA met most of its performance goals for priority and standard original efficacy supplements to approved NDAs and BLAs from 2000 through 2010. But the average review time generally increased for both priority and standard efficacy supplements. The percentage of first-cycle approvals fluctuated for priority efficacy supplements, but generally increased for standard efficacy supplements for the fiscal years 2000 through 2010.

Hat tip to FDA Law blog