You can't admit it without sounding like a jerk, but the Chilean miners have been getting too much coverage in the news. Chilean miners and their endearing optimism, Chilean miners and their complicated love lives, Chilean miners running the NY marathon, Chilean miners, Chilean miners, Chilean miners.
When we got the hair-on-fire announcement about an emergency, Thanksgiving-week-be-damned ACLA/AMP meeting with FDA to discuss LDTs, we were actually looking forward to it. Anything would be a welcome respite from Chilean miner news stories.
The email announcement made this meeting sound like it would be important. Instead, it was a rehash of all of the arguments from the last five years about why some labs still don't want FDA to have regulatory oversight for LDTs. If ever there were groups of people not communicating effectively, it was at this meeting.
Here is a five-minute summary of the meeting:
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Labs: |
Why doesn’t CLIA just have oversight over LDTs? |
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FDA: |
CLIA evaluates compliance with lab procedures and FDA evaluates clinical validity. |
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Labs: |
How do we know what constitutes a LDT? |
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FDA: |
It is a self-defined term. |
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Labs: |
We need you to draw the line in the sand for us. What is in this guidance document and when is it coming out? And oh, by the way, you are stifling innovation and patient care. |
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Agendia: |
We are regulated, we have an LDT, it was easy, and if we can do it, so can you. |
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Labs: |
When will we see a guidance document? |
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FDA: |
We can't answer that; we are in the process of framing the draft document. Once it is complete, we will issue the draft and there will be plenty of time for comments. After the guidance is approved, we will begin enforcing new regulations on a priority basis with the most risky tests first and this will be implemented over a period of time. |
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Labs: |
But you will put us out of business! Will PAP tests be regulated? When is the document coming? |
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FDA: |
No estimate on when document is coming; won't be tomorrow; you will have plenty of time to plan before enforcement becomes a reality. |
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Labs: |
We can't possibly work within QSR, we can't control the RUO reagents we use to make our LDTs and we don't have the instrumentation for some of the FDA approved tests so we have to make our own. Innovation and patient care will be affected if you regulate us. How about CLIA regulates us? |
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CLIA: |
No. |
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Labs: |
When is the document coming? |
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Agendia: |
We had no problems getting an approval, don't be afraid. |
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FDA: |
No estimate on when document is coming won't be tomorrow; you will have plenty of time to plan before implementation becomes a reality. |
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Labs: |
This was really productive. We feel better. |
So the news is not new about LDTs and their impending regulatory oversight. The whole discussion can still fit on a couple PowerPoint slides:
FDA
- Claims jurisdiction over LDTs
- Does not like risky complex tests on the market with no proof of clinical validity
- Will continue to work on a draft guidance document that will eventually be released for comments and then implemented on a priority basis
Labs
- Want no change
- Want no additional regulation
- Are afraid of the impact of regulatory oversight on innovation and process
- Believe they can't possibly work under QSR.
Agendia
- Still remembers how successful MammaPrint has been
- Still doesn't see why labs are making such a fuss
This is turning into a rerun, time to turn the channel and see what the Chilean miners are up to.
