Regulatory Focus™ > News Articles > FDA Prepares Plan to Conduct 'Exit Interviews' With NDA, BLA Sponsors

FDA Prepares Plan to Conduct 'Exit Interviews' With NDA, BLA Sponsors

Posted 15 February 2013 | By Alexander Gaffney, RAC

Exit interviews have long been a tactic of companies looking to collect and understand the opinions of staff, usually when they depart. But now a similar tactic is being proposed by the US Food and Drug Administration (FDA) under the terms of recently passed legislation that would allow an entity acting on its behalf to assess the views of some sponsors of innovative products.


Under the terms of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V), passed under the FDA Safety and Innovation Act (FDASIA), FDA agreed to establish a new review program aimed at improving transparency and communication between itself and members of industry.

Those goals, contained with Section II(B) of the PDUFA V commitment letter signed by FDA, describes assessment procedures meant to look back on the submission and review process associated with new molecular entities (NMEs) submitted via a new drug application (NDA) or biologics licensing application (BLA).

With the help of an independent contractor acting on behalf of FDA, the agency will collect and evaluate metrics regarding its performance in relation to PDUFA V's goals, including sending Day 74 letters, timing, handling of amendments, communications and its outlining of potential issues.

"A key aspect of the Program is an interim and final assessment that will evaluate how well the parameters of the Program have achieved the intended goals," FDA explained in a Federal Register posting due for publication on 19 February 2013.

The interim assessment, due by 31 March 2015, is meant to allow for mid-cycle corrections of PDUFA V if the report determines that either industry or FDA isn't living up to its stated commitments. The second, final assessment is meant to drive discussions into the (likely) PDUFA VI reauthorization negotiations, which generally start about two years before the end date of the current PDUFA program. That report is due by 31 December 2016.

Exit Interviews

But what those assessments are supposed to entail and how they are conducted are left vague in the assessment letter, and FDA's 19 February Federal Register posting is meant to convey more information regarding the nuts and bolts of the assessment.

The selected contractor, it explains, is Eastern Research Group (ERG), a consulting firm based out of Massachusetts but with offices in Virginia.

The current plan, FDA continued, is to have ERG conduct "independent interviews of applicants after FDA issues a first-cycle action for applications reviewed under the program."

Call it an FDA exit interview, if you will. All data will be anonymized and aggregated to promote truthful responses, which it said may be presented at public meetings.

The plan calls for interviewing all NDA and BLA sponsors, of which there are an estimated 40 to 45 each year. Each interview will take approximately 1-1.5 hours to conduct and involve anywhere between one and three representatives from each sponsor, to be interviewed at the same time.

Tags: BLA, NDA

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