By Kim Simmons, Lead Articles Editor
On Wednesday, March 31, 2020, the U.S. Food and Drug Administration (“FDA”) announced a new program, known as the Coronavirus Treatment Acceleration Program (CTAP), to expedite the development of potentially safe and effective life-saving treatments for the COVID-19 virus[1]. As part of the CTAP, the FDA has redeployed medical and regulatory staff to serve on review teams dedicated to COVID-19 therapies[2].
From a pragmatic standpoint, the FDA says that it is turning things around much more quickly, reviewing protocols for many freshly submitted clinical studies within 24 hours, and also turning around single-patient requests for expanded access to some therapies granted under compassionate or investigate use “generally within three hours[3].” The FDA urges that it has also streamlined processes and operations for developers and scientists to send inquiries and requests and provided resources to health care providers and researchers to help them submit emergency requests to use investigational products.[4]
Effectively, what this means is that more than 110 labs and test developers across the country did not have to wait for the FDA to review their tests before patient testing–they only needed to confirm the tests work[5]. Relaxing the regulatory requirements has led to an exponential growth in the availability of tests across the country—a whopping 18.5 million tests have been distributed to date[6]. With this streamlined process, there may be concern with inaccurate test results or ineffective results on tested patients. In response to these concerns, FDA Commissioner Dr. Stephen Hahn has issued a statement assuring that the FDA is “working to ensure that the tests are accurate and that our policies strike the right balance of scientific oversight while expediting testing availability[7].”
Currently, there are a variety of therapeutic defenses to COVID-19 that are being evaluated.[8] Potential medicinal therapies include antiviral drugs like remdesivir that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients.[9] Additionally, there has been interest in exploring whether therapies such as convalescent plasma and hyperimmune globulin—antibody-rich blood products that are taken from blood donated by people who have recovered from the virus—could shorten the length or lessen the severity of the illness.[10] Alternatively, there is ongoing analysis of whether existing therapies such as chloroquine and hydroxychloroquine help treat patients with COVID-19.[11]
The implications of the FDA’s Coronavirus Treatment Acceleration Program may be hotly contested.[12] The benefits of the CTAP is that it should help novel approaches and even startups in the biotech space with unproven, but promising technologies in development to work hand-in-hand with the FDA on potential remedies to COVID-19.[13] Critics, however, are likely to reiterate criticisms of some of the FDA’s other aggressive decisions regarding COVID-19 therapeutics, including the Emergency Use Authorization ordered for anti-malarial hydroxychlroquine.[14] In that situation, small scale studies showed that anti-malarial hydroxychloroquine could offer some benefit in the treatment of COVID-19 patients.[15] Despite the highly speculative nature of the drug—the key fact is that the drug could offer some benefit—and the fact that there is not enough data available to say anything definitively either way, the result of the Emergency Use Authorization is that efforts to stockpile the drug could make it less available to those who use it for another of its common purposes.[16]
Given the urgency of the COVID-19 pandemic, FDA developments are likely to frequently change.[17] However, as of April 4, 2020, the FDA reported 10 therapeutic agents in active trials and another 15 therapeutic agents in planning stages.[18]
[1] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[2] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[3] See Darrell Etherington, FDA Introduces a New Program to Expedite Deployment of Potential Coronavirus Treatments (Mar. 31, 2020), https://techcrunch.com/2020/03/31/fda-introduces-a-new-program-to-expedite-deployment-of-potential-coronavirus-treatments/.
[4] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[5] See Dr. Stephen Hahn, What We at the FDA Are Doing to Fight Covid-19 (Mar. 30, 2020) https://www.cnn.com/2020/03/30/opinions/fda-coronavirus-vaccine-testing-hahn/index.html.
[6] See Dr. Stephen Hahn, What We at the FDA Are Doing to Fight Covid-19 (Mar. 30, 2020) https://www.cnn.com/2020/03/30/opinions/fda-coronavirus-vaccine-testing-hahn/index.html.
[7] See Dr. Stephen Hahn, What We at the FDA Are Doing to Fight Covid-19 (Mar. 30, 2020) https://www.cnn.com/2020/03/30/opinions/fda-coronavirus-vaccine-testing-hahn/index.html.
[8] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[9] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[10] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[11] See Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19.
[12] See Darrell Etherington, FDA Introduces a New Program to Expedite Deployment of Potential Coronavirus Treatments (Mar. 31, 2020), https://techcrunch.com/2020/03/31/fda-introduces-a-new-program-to-expedite-deployment-of-potential-coronavirus-treatments/.
[13] See Darrell Etherington, FDA Introduces a New Program to Expedite Deployment of Potential Coronavirus Treatments (Mar. 31, 2020), https://techcrunch.com/2020/03/31/fda-introduces-a-new-program-to-expedite-deployment-of-potential-coronavirus-treatments/.
[14] See Darrell Etherington, FDA Introduces a New Program to Expedite Deployment of Potential Coronavirus Treatments (Mar. 31, 2020), https://techcrunch.com/2020/03/31/fda-introduces-a-new-program-to-expedite-deployment-of-potential-coronavirus-treatments/.
[15] See Darrell Etherington, FDA Introduces a New Program to Expedite Deployment of Potential Coronavirus Treatments (Mar. 31, 2020), https://techcrunch.com/2020/03/31/fda-introduces-a-new-program-to-expedite-deployment-of-potential-coronavirus-treatments/.
[16] See Darrell Etherington, FDA Introduces a New Program to Expedite Deployment of Potential Coronavirus Treatments (Mar. 31, 2020), https://techcrunch.com/2020/03/31/fda-introduces-a-new-program-to-expedite-deployment-of-potential-coronavirus-treatments/.
[17] See Coronavirus Treatment Acceleration Program, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap (last visited Apr. 4, 2020).
[18] See Coronavirus Treatment Acceleration Program, U.S. Food & Drug Admin, (Mar. 31, 2020), https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap (last visited Apr. 4, 2020).