LDT Guidance Documents... Where are They?

Friday, June 15, 2012
Missing Guidance

As reported in a recent FiercePharma ebook OIVD has developed a set of guidance documents proposing how LDTs should be regulated. Whether we expect to like them or not, many of us are deeply curious to see these documents and start formulating comments.

So where are they?

This came up at last week's FDA-Industry IVD Roundtable. Apparently they are stuck somewhere in OMB. Don St. Pierre quipped that he's offered them his blood to them get these documents moving but "...apparently they don't want my blood." Don, in case you don't already know him, is Deputy Director for New Product Evaluation for OIVD.

If the guidance documents are at OMB, it's not clear exactly where at OMB they are. A quick search of OIRA's review docket doesn't list them. If the White House is delaying review of these documents it wouldn't be the first time politics has trumped consistency. Plan B and a recent New York Times article suggest that interference is certainly possible.

Lack of clarity on this issue may be of benefit for some companies but mostly I hear from my clients (LDT, IVD and pharma alike) that being able to anticipate the future, even a more regulated future, is far better than trying to plan for uncertainty. Releasing the draft guidance document would be a big step in letting industry know FDA's thinking on how this could be achieved and allow us to begin concrete planning for the future.

I'd be happy to be a blood donor, too. Maybe if we call get together on this we can make something happen.

Tags: CDRH, IVD, LDTs

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