FDA Back on Track With Approvals

FDA Back on Track With Approvals

June 29th, 2012 // 12:47 pm @

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While the latest iteration of the Prescription Drug and User Fee Act, or PDUFA V, is awaiting the Presidential signature, FDA officials are talking up their accomplishments. Specifically, the agency is taking every opportunity to remind lawmakers that its track record for approving medicines is getting better, at least according to data presented to investors at a conference earlier this week.

For instance, the new workload associated with implementing the FDA Amendments Act of 2007 made it difficult for the agency to meet its PDUFA goals in fiscal years 2008 and 2008, but John Jenkins, who heads the Office of New Drugs in the Center for Drug Evaluation and Research, maintains review performance was still in the 80 percent to 90 percent range many of applications that missed first‐cycle PDUFA goals were approved on the first cycle.

“The wheels did not come off the wagon,” one slide states in his presentation. “We are now back on track and meeting/exceeding nearly all of our PDUFA goals for application review.” For the past two years, for instance, the CDER review performance for New Drug Applications, Biologics License Applications and supplemental applications has exceeded 90 percent.

Meanwhile, CDER last year approved 30 New Molecular Entity applications, which was the highest number since 2004. Meanwhile, the NME filings last year totaled 39, which was higher than the 30.6 average per year between 2006 and 2010. Through June 18, 2012, CDER has approved 12 NME applications and received 15 NME applications for filing, which works out to a higher percentage of approved NME applications than in 2011. Jenkins also noted that roughly one-third of the NME approvals in each of the last six years – and through mid-June this year – have been for rare diseases.

Meanwhile, so-called first action approval rates for priority NMEs and NBEs (New Biologic Entities) reached 71 percent, on average, over the past four years, although the rate last year was the highest in nearly two decades. The same was true for first action approval rates for standard NMEs and NBEs, although these rates were uniformly well below the rates achieved for the priority applications.

And for those watching the clock, the median approval time for NMEs and NBEs reached 9.9 months last year, just about the same as the 10 months notched in 2010, but below 13 months in 2008 and 2009. The figures are based on NME approvals to date, elapsed time of NMEs in process, and the historic approval rate of 75 percent to 80 percent of NMEs filed in a given year eventually gain FDA approval, he noted.


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