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Speech

Event Title
Remarks by FDA Commissioner Stephen Hahn to the American Clinical Laboratory Association
March 4, 2020

Speech by
Stephen M. Hahn, M.D.
Leadership Role
Commissioner of Food and Drugs - Food and Drug Administration

(Remarks as prepared for delivery)

Good morning.  I’m delighted to be with you today.

I appreciate this opportunity to introduce myself to the members of this important organization and to have the chance to engage in discussion about some of the key issues in which we share an interest.

Many of the issues that are important to the ACLA have played a central role throughout my career – as a researcher, a cancer physician, someone who has led medical research institutions – and now, as Commissioner of the FDA.

What is more, my experience running a large medical center has underscored for me just how important to a modern, efficient healthcare system are the laboratory developed tests and other work your institutions deliver. 

Patients rely on the innovation you provide and place their trust in the tests you conduct and review.  

I’ll talk more about those tests this morning, but first I want to focus on another issue – no doubt the biggest issue on all our minds – the coronavirus.

The President and this Administration have taken an unprecedented whole-of-government approach to protect the American people, including steps in the last few days to expand testing and improve access to certain respirators needed by healthcare workers.

COVID-19 Response

As members of the healthcare community, we are all keenly focused on seeing our country through this emergency. Whether as regulators or test developers, we are united in our resolve to do our best to detect and treat infected patients and manage the spread of the disease.

In past public health emergencies, we have been able to rely on sufficient testing capacity across the national network of public health labs under the EUA pathway to meet all our immediate testing needs.

The EUA is very straightforward: for diagnostics, we share a template submission with developers, work with them on a rolling basis, and turn around the review very quickly – often within a day of receiving the complete data package.

But this emergency is different and requires a different response. We’ve seen manufacturing issues that prevented the use of the first, and for some time only, EUA authorized test across the network of public health labs. We’ve also seen an imminent need for testing beyond just the public health labs – the need for testing capabilities in local hospitals as well.

There’s another key issue relating to testing that I know you deal with every day, and that has even greater significance during a crisis like this one.  That is the understanding that we have to get the tests right.

Everyone in this room knows all too well that false results – especially in the context of an emergency -- can have broad public health impact, beyond simply on the individual patient being tested.

The good news is that the country’s capacity for testing is growing.  This past weekend, we announced our new policy regarding certain labs immediately using tests they developed and validated in order to achieve more rapid testing capacity in the U.S.

The EUA standard has not changed, but now, certain labs that develop and validate an LDT can begin running it immediately, as described in the guidance.

We know responsible labs validate tests before they run them. They get the science right up front and, under this new policy, will follow up with the independent check by FDA later. We are asking for submission of an EUA within 15 days of testing. This means they have 15 days to simply email us the validation of the test that was already done. 

Our guidance lays out a recommended way to validate a test for SARS-CoV-2; following those recommendations is one way to get a thumbs up to test specimens while you prepare your EUA request; and we can talk to you if you have a different approach.

Separately, we have been engaging with dozens of developers in the diagnostic space during this outbreak. And we are working quickly. When we received two complete EUA requests for diagnostics, we turned them around and authorized them in 24 hours.

Additionally, we have heard from multiple academic centers and public health labs, and we expect for some of them to begin testing this week, next week and throughout the month.

We know that increasing the numbers of distributed CDC tests , including those that are being distributed by the contract manufacturer IDT (Integrated DNA Technologies) under the CDC’s EUA, is also crucial.  IDT reports that they are targeting manufacturing 2,500 of these test kits, with about 500 tests per kit by the end of the week.

But even with these developments, we strongly encourage additional developers in this space.

Laboratory Developed Tests

As this discussion indicates, the current emergency is a prime example of just how important LDTs are to healthcare, and the critical role they can play in daily, nonemergency situations as well.

The FDA has a long history of oversight of LDTs, dating to 1976. The Agency has always exercised enforcement discretion for these types of in vitro diagnostic devices.  And we want continue to demonstrate regulatory flexibility, particularly in times of public health emergencies.

But it is essential that we are able to ensure the continuing availability of high-quality laboratory tests that help us diagnose and treat disease, and give patients the fast, definitive, and accurate answers they need to make informed choices about their medical treatment.

Now, let me say at the outset of this discussion that there are LDTs out there that are good and done well and safely.

But there are also some that are not. Take, for example, some of the pharmacogenomic claims that have been made.

We’ve seen clear situations where even the developer acknowledged they did not have evidence to support the claims they were making.

We saw tests that claimed certain patients may need higher doses of opioids when there was no evidence to support it.  Opioids. They were incorrectly telling patients and providers that some needed higher doses.

Certainly, not all pharmacogenomic tests are wrong.  But some were and some of these mistakes were not minor ones.  This both can endanger patients and erode confidence.

It’s also important to note that even some of the best developers sometimes can get it wrong. That’s precisely why we need an independent check.

I know our actions in this space have been viewed by some of the members of this organization as controversial.  We want to work with you to ensure the right regulatory balance.

Consider a slightly different example.  If you’re building a house, you have regulations to ensure the materials are of good quality and the work is being done in ways that won’t endanger the safety of the future residents of that house. 

It should be no different for diagnostic tests, and particularly complicated tests, regardless of who makes them.

We are strongly committed to the legislative process. And we are committed to engaging with stakeholders including the ACLA, as we have done to this point.

As someone who has been on both ends of this regulatory structure, I urge you to carefully consider the importance of having the right kind of oversight to help to ensure the use of analytically and clinically valid tests. 

The American public must have confidence in the safety of these tests and they depend on the FDA to ensure that reliability.

My work at and in leading large medical centers has given great insight into the challenges you face. 

I understand and can empathize with laboratories within academic medical centers who have tight budgets and perhaps don’t always have the funds they need.  To this end, I call on the larger institutions to give the laboratories operating within their walls the financial support they need to work within an appropriate framework of regulatory oversight.

We need to make sure that our tests are accurate, reliable, and clinically meaningful. We are in this together and the American people depend on us.

I look forward to working with the members of the ACLA on these issues and others.  I believe you share our priorities, including using the power of data; empowering American patients and consumers to make the best choices they can, and increasing choice and competition through innovation. 

Working together we will not only get through the current COVID-19 emergency but move forward in other ways to strengthen our health care system, promote innovation, and continue to use cutting edge science for the benefit of patients. 

Thank you.

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