- Speech by
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
(Remarks as prepared for delivery)
Thank you for joining me today to provide updated information about the current state of diagnostic testing during this coronavirus public health emergency.
First, I want to thank the dedicated professionals of the FDA for their round the clock, multi-layered approach to the coronavirus outbreak. I’d also like to thank our partners from across the federal government, such as HHS, CDC, CMS, and BARDA. I had the opportunity to speak with my CDC colleagues, Dr. Bob Redfield and Dr. Anne Schuchat this morning to exchange the most current updates from our respective agencies. I am appreciative of the leadership of President Trump, Vice President Pence, and Secretary Azar and of the partnership and the cross-collaborative work our team performs together every day within the Department of Health and Human Services and across the entirety of the U.S. government to our public health mission.
This is a dynamic and constantly evolving situation. Not just day by day, but hour by hour. I also recognize this has led to some confusion about the quantity of diagnostic tests available and how many patients can be tested.
As the President, Vice President, and Secretary have promised, we are committed to being transparent about this situation, so today I will provide you the most comprehensive and up to date information about the status of diagnostic tests and information about who should be tested.
Before we get to the most current numbers, I’d like to provide an explanation about the role of diagnostics in emergencies, and why this particular situation has been a bit more complex than past outbreaks. I hope this will provide much needed clarity to the American public.
First, we should paint a picture of what is happening globally. The World Health Organization (or WHO) also supports the establishment of testing capability by collecting and sharing that information provided by developers, including protocols for diagnostic testing and testing assays. We’ve seen reports about the WHO distributing a diagnostic test to countries. To be clear, the WHO does not have its own test that it is distributing globally. It has only posted on its website protocols from some test developers, such as the CDC.
Also, internationally, different countries have had different levels of success with their diagnostic test development. For example, we understand from a test developer that there have been problems with the performance of several tests being used that country. Despite media reports on testing capabilities in other countries, I do not want to speculate on the policies and procedures related to the development and validation of tests in other countries.
In the U.S., we have policies in place that strike the right balance during public health emergencies of ensuring critical independent review by the scientific and public health experts and timely test availability.
As I have mentioned previously regarding the development process, in the U.S., the CDC is typically the first developer of a diagnostics for an emergency because they have access to clinical specimens and viral samples before other developers. They work to make this material available for other developers to use in validation of their tests. The CDC test can and often does become the basis for tests that other developers create. The CDC test is an incredibly important tool during a public health emergency response.
In this case, once the CDC had access to clinical specimens, and similar to past emergencies, the FDA immediately began working with our public health partners at the CDC to support the development of the CDC diagnostic test, including working with the CDC through their emergency use authorization process.
There were manufacturing problems with the CDC test. While those issues have been resolved, at the time, this created complications for expanding access for public health laboratories and other developers who might use the CDC test as the basis for development of their own test. What’s important here is that we have a test that the American people can trust.
The FDA and CDC worked together to quickly resolve the manufacturing issues and utilize a third-party manufacturer to assist with manufacturing the tests for not only the state public health labs, but also for commercial distribution to nonpublic health labs, including academic medical centers, community hospitals, and more.
That manufacturer has been quickly producing tests for distribution. It is important to note, though, that each lot of these tests must undergo quality control testing by CDC, an essential and required last step to assure that each test provides accurate results. Quality testing, distribution of tests, and verification of the tests in labs can take a few days, although FDA, CDC staff, and the laboratory community are working around the clock to speed up these processes.
Separate from the manufacturing challenges, the CDC has been quickly working to update the clinical recommendations for testing patients based on emerging information about the presentation of the disease in patients. The COVID-19 virus has a long incubation period and mild cases can go undetected because patients may have so few symptoms, thus adding to the difficulty with diagnosing the disease. The CDC test is a high quality test and it’s important to remember that false negatives or positives can be detrimental to making sure we are treating patients early, without delay, and also not quarantining healthy individuals.
With that landscape, let me provide you with a comprehensive update on numbers:
- CDC has shipped tests sufficient to test about 75,000 individuals for COVID-19 to Public Health Laboratories. And all Public Health Laboratories that originally received a CDC test have received replacement tests. Laboratories in areas with the highest need for testing based on the outbreak have received additional tests, however, all state public health labs now have tests available to them.
- As of today, the CDC test shipped to public health labs has been able to test more than 3,500 specimens from 1,583 patients.
- Additionally, as of last night, more than 1.1 million tests have been shipped to nonpublic health labs.
- The manufacturer, IDT, is distributing these tests nationwide, although the first batch of tests were shipped to the states of California and Washington based on confirmed clusters in those areas.
- IDT currently has another 400,000 tests which have undergone and passed final quality control check and we expect those tests to ship to labs on Monday.
- Another manufacturer’s tests will be undergoing a quality control check. That batch of 640,000 tests could ship as early as Monday.
- IDT and other manufacturers believe they can scale up production so that by the end of next week tests, an additional 4 million tests could be shipped.
- This does not include the ramp up expected by large commercial or academic labs.
A very important point I want to make here is about the reporting of numbers. I promised yesterday to explain a bit about the distinction between the number of tests shipped compared to the number of patients that could be tested. The actual number of tests that have shipped is larger than the number of patients that can be tested. With current estimates (and this could change), 2.1 million tests would roughly translate to 850,000 Americans being able to undergo testing.
We’ve been asked a lot of questions about capacity of the labs to run these tests. When a lab will begin offering tests, and how many tests per day a lab has the ability to conduct, will depend on each individual lab. There are additional steps each lab needs to take after receipt of tests in order to deploy those tests, including verification of the tests and training for staff if they have never run the test before. The volume for testing (or the number of tests that can be run) will also vary widely and will depend on the size of the lab.
Finally, I want to end with a quick update on ways that FDA is supporting all diagnostic developers during this time. FDA received its first request for an EUA template on January 22nd and we sent the template to them the same day. We have since received over 100 requests for the template. Of those, 36 sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. We are talking to them around the clock, and our door is open for any developers who want to have a test for use in the U.S.
Additionally, we issued a policy last weekend to achieve more rapid testing in the U.S. We have provided regulatory relief and clarity to encourage the development of new diagnostic tests for Americans. Under that new policy, we have heard from 7 labs, 4 of whom already have begun patient testing.
Rest assured, we are dedicating all available resources to address this outbreak and expedite the availability of diagnostics.
I am happy to take some of your questions.