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FDA’s Woodcock on How the Agency's Multivariate Guidance Will Affect Diagnostics


Janet Woodcock
Deputy commissioner of operations and chief operating officer
Office of the Commissioner, FDA
Name: Janet Woodcock
Position: Deputy commissioner of operations and chief
operating officer, Office of the Commissioner, FDA, 2005 - present
Background: Director of the Center for Drug Evaluation and Research, FDA, 1994-2005; medical officer, Division of Biological Investigational New Drugs, CBER, 1986-1992
Education: MD, Northwestern University Medical School, 1977

The US Food and Drug Administration’s draft guidance for multivariate index assays, released early this month, recommends that companies who market diagnostics that use an algorithm to analyze multiple data points should file an application for either premarket approval or a 510(k).
The guidance states that these tests are in the regulatory reach of the FDA, even though some testing companies have assumed that the agency does not have oversight over tests developed as so-called “homebrew” diagnostics and performed solely within CLIA labs.
Pharmacogenomics Reporter last week spoke with Janet Woodcock, deputy commissioner of operations and chief operating officer at the FDA, about the effect the draft may have on the molecular diagnostics industry.
Have you been involved in the multivariate index assay guidance from your position at the FDA?
I was actually quite involved in that guidance. It’s all part of an overall approach that the FDA is developing towards these new, emerging assays both in pharmacogenomics and standalone assays.
It seems there are probably a lot of these assays that were marketed and performed solely under the Clinical Laboratories Improvement Act guidelines. Will those now become regulated under the FDA?
[Those] were always subject to FDA jurisdiction. However, for some types of assays, we are allowing them to be done in CLIA laboratories.
The point is, for example, for some of these tests that we’ve approved already that are for targeted therapies — for a therapeutic that’s been approved [and] predicated on performing a test, these tests have been approved by the FDA. [That is], the tests are in the label of the drug.
So that isn’t new — the fact that we would like those to be approved tests when we’re actually using them to give directions about whether or not a patient gets therapy. So, in other words, we think this is all a consistent approach that we are developing.
The guidance is out for comment — it’s a draft guidance, and so it’s still open for public comment and potential revision.
If things should proceed the way they have been, are there tests on the market that are going to have to apply for premarket review now?
There may well be tests. I can’t specifically refer to any tests, obviously, but there may well be tests that fit this definition that are out there now.
‘May well be’? Aren’t there?
Until FDA has looked into a given test and evaluated, we can’t say for sure, obviously.
That ‘there may well be’ is as close as I can get.
How many may there well be?
That I don’t know. I mean, there are tests coming on all the time, and many of the newer tests are algorithm-based, index-type of assays that we’re discussing in this guidance.
We have previously talked to companies that have been marketing some of these assays. We’ve told them these things are subject to FDA jurisdiction. We have a number of them under IVD now, or they expect to come in and file once they complete the PMA or 510(k).
So, this isn’t completely new, and some of these tests — actually, there are tests that are out there — investigational tests — we know they exist, there are some that are already working with the FDA.
Then there are companies who won’t be blindsided?
There certainly are companies who will not be surprised to hear this information. There may be others who had business plans going in other directions that may be surprised by it.
I think your statement is fair — those major players probably won’t be blindsided by this guidance.
Can you tell me whether there has been a rethinking of analyte specific reagents?
We don’t believe we’re changing that at all; we issued a draft guidance clarifying our policy  We’ve had the policy in effect for some time, and people were confused by certain aspects of it, and so we clarified it in the document.
Will this change much in the way that companies do business in the molecular diagnostics and reagents fields?
Probably not for the ASRs, but for the index assays, yes. In the draft guidance, we’re proposing that companies either submit 510(k)s or they submit information to determine whether they would need premarket clearance by the FDA before going on the market.
Is there any way to get an idea of the size of the regulatory burden?
We are going to try to minimize the burden as much as possible. Our goal here is that we do not want to discourage innovation in this field. We recognize how important it is. On the other hand, we want to maintain the quality standards in this field so that patients can rely upon the information.
In many cases, these tests will say whether or not you should have a therapy, or whether you’re at high risk for some event, and give different information like that.
That’s the kind of thing people really need to know is reliable.
Have you heard any comments that diagnostics companies plan to issue in response to the draft guidance?
I did talk to a number of diagnostic companies after [the draft guidance] was released. It didn’t come as a complete surprise to the companies, but basically they’re evaluating it now.
Is there anything that you foresee companies being most concerned about?
For companies, there are different issues — there’s the concern that they’ll be slowed down or they’ll have a regulatory burden, particularly in conforming to the quality standards that the FDA has. On the other hand, there’s a recognition that for this field to advance — there’s a great opportunity in this field for claims that cannot be verified by anyone, and you don’t want tests that are unreliable out there on the market. It can give the whole field a very bad name.
This field, in my mind I feel very strongly, needs to advance, it needs to gain status, and it needs to have recognition by reimbursement and use by the clinical community.
Might the multivariate guidance affect reimbursement indirectly?
Maybe indirectly, that’s right.
Are there other implications for pharmacogenomics and personalized medicine, from your point of view?
What I would say is, this is part of growing pains. As I said, this field needs to join the ranks of medical therapy and medical diagnosis. These tests need to be something that your doctor can order up for you without going through a tremendous amount of investigation and everything to figure out what to do.
They need to become a routine part of medicine — hopefully paid for by insurance — and they need to show their value. But there’s tremendous promise here — it’s personalized medicine starting to actually pay off.

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