A Not So Sweet 16 for FDA and PDUFA!

April 21, 2010

Last Friday, several days after FDA held a meeting on the public’s assessment of the overall performance of the fourth iteration of the Prescription Drug User Fee Act (“PDUFA”), which was reauthorized as Title I of the 2007 FDA Amendments Act (“FDAAA”), and what aspects of the program should be retained, changed, or discontinued in the next iteration of the program – PDUFA V – when it comes up for reauthorization (PDUFA IV expires at the end of September 2012), FDA quietly made public the Agency’s FY 2008 PDUFA Performance Report. There was no FDA press release, no notice on FDA’s “What’s New (Drugs)” website – and, in fact, there is not yet any mention of the report on FDA’s PDUFA website (as of publication of this post). BioCentury (subscription required) reported on the report over the weekend, but other than that, no one else has mentioned the report in print.

So why has FDA been radio silent on the FY 2008 PDUFA Performance Report, which marks the 16th year of PDUFA and the beginning of PDUFA IV? After all, industry knew some of what to expect after Office of New Drugs (“OND”) Director Dr. John Jenkins presented some figures at Windhover’s December 2009 FDA/CMS Summit. Well, there is not much in the FY 2008 Performance Report that FDA can tout as a success – many of the performance goals FDA agreed to under PDUFA IV have not been met. As FDA Commissioner Dr. Margaret Hamburg states in a preface to the report, “performance in many traditionally strong PDUFA goal areas decreased in FY 2008; and, therefore, this report presents a picture of mixed success.”

According to FDA, much of the “mixed success” is due to FDAAA, which, among other things, gave FDA increased responsibilities and authorities regarding the post-market safety of drugs (e.g., Risk Evaluation and Mitigation Strategies). “[T]he changes and challenges that FDA faces in PDUFA IV as a result of the expansion of FDA’s responsibilities under FDAAA place unprecedented demands on FDA reviewer workloads. These added responsibilities can also have unintended and unexpected impacts on FDA’s short-term abilities to meet PDUFA IV goals,” according to the FY 2008 Performance Report. Given these increased responsibilities, in November 2007, Dr. Jenkins granted permission for OND managers to exercise greater flexibility regarding PDUFA goals. That permission was later documented in a communication to FDAers. In October 2009, Dr. Jenkins withdrew that permission and instructed OND managers to begin moving back to the “prior posture of meeting PDUFA goals whenever possible.”

Below are some of the facts and figures of note from the FY 2008 Performance Report. FDA agreed to a “90% on time” goal under PDUFA IV for each item. Also, in each case, a “highest potential performance” statistic is provided. This statistic assumes that FDA will meet a pending and not overdue item.

Original Applications (FY 2008 Submissions)