FDA is predicting a sharp drop-off in fee-paying drug and biologic applications in the current fiscal year.
In a Federal Register notice announcing the fiscal 2011 PDUFA fee rates for applications, establishments and products, FDA estimates it will receive 117.5 fee-paying full application equivalents in fiscal 2010. This figure represents a 16.3 percent drop from the 2009 level of 140.3 FAEs.
(The 2010 projection of 117.5 FAEs is based upon receipt of 88.125 fee-paying FAEs through the first nine months of the fiscal year. On average, 25 percent of the applications submitted each year come in the final three months, the agency says, citing data from the last 10 fiscal years.)
That means 2010 would mark the lowest number of applications submitted since 1995, when 112.5 FAEs were received by the agency. The 1995 figure, however, did not include pediatric supplements, which were exempt from application fees until 2002. When pediatric supplements are factored in, 1994 was the next lowest year, with 115.6.
Why? It’s largely due to a 25 percent decline in applications requiring clinical data. FDA had received 59 such applications through June 30, of which 17 were either exempt or fees were waived, bringing the total number of fee-paying applications to 42. In contrast, during the first nine months of fiscal 2009 the agency received 88.75 applications requiring clinical data, 32.75 of which were fee-exempt or waived, for a total of 56 fee-paying applications.
The total number of fee-paying applications not requiring clinical data declined 23 percent through the first nine months, from 11 last year to 8.5, while the number of fee-paying supplements requiring clinical data fell 5 percent, from 39 last year to 37. The number of fee-paying applications withdrawn or refused to file held steady at .625.
PDUFA implications? Sure. But the pure decline speaks to a much more troubling issue: a parse pipeline. Now more than ever we need a well-funded Reagan/Udall Center assist us all down the Critical Path.
(Hat tip to Sweet Sue Sutter @ the Pink Sheet.)
