Tuesday, September 16, 2008

FDAAA Delays: Hurry Up and Wait

If you are going to be late, you might as well be late on everything.

That appears to be the mantra of the Food & Drug Administration these days. After alerting industry earlier this year to the fact that it would start missing approval deadlines, FDA is now warning members of Congress that it will miss implementation deadlines under the FDA Amendments Act.

As reported in "The Pink Sheet" this week, the first anniversary of FDAAA's passage on September 27 comes with it a spate of provisions with deadlines for implementation.

We don't claim to have any insight as to which ones won't happen as planned, but the dozen or so deadlines include one that should be of special interest to the drug industry: the start of the priority review tropical disease voucher system. Others include a report to Congress on best practices for communicating the risk-benefit balance to the public and the development of a post-marketing drug safety website.

So far, we're hearing that Congressional members aren't too concerned about the missed deadlines. Which makes sense, given that FDA hasn't exactly had an on-time record for FDAAA over the past year. For example, the agency is already quite late on a report to Congress on the number of vacancies and disclosures related to advisory committees; it was due February 1.

We find the whole situation a bit ironic, since FDA has been telling sponsors that part of the reason it is missing user fee deadlines is because of all the work it is doing under FDAAA. The news that the agency will miss those deadlines as well seems to illustrate just how severly understaffed FDA actually is.

FDA is staffing up--of the 1,163 or so new employees that the agency will hire before the end of the fiscal year, 1,005 are already on board, and 158 are due to report in by September 28, according to FDA. Another 160 candidates have accepted offers but are still undergoing clearance and related security processes.

But even with all those new hires, FDA still has vacancies: The recent Food & Drug Law Institute advertising and promotions meeting, for example, sounded at times like a government job fair, with officials making a pitch for working at FDA from the podium.

Given the scope of the Amendments Act, perhaps missing deadlines was inevitable. For sponsors, whether or not FDA sends a report to Congress won't make or break a balance sheet. But it is just another reminder of just how stretched the agency is--and how long it will take before agency operations are back to normal.

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