The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
As part of those efforts, President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19.
The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.
"President Trump’s aggressive response and bold actions to keep Americans safe from COVID-19 bought us precious time to advance therapeutics and other necessary tools," said HHS Secretary Alex Azar. "Today's actions show that HHS and the United States are leading the world in these efforts. Disseminating information about promising off-label uses of drugs we already have, investigating their effectiveness, and pursuing other therapeutics will help give American healthcare providers the tools they need to save lives. As we have always seen when America has faced a serious threat, American industry, academic institutions and government are coming together to deliver us what we need to win."
The FDA wants to assure the American public that the agency continues to work with partners across the U.S. government and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus, including repurposing existing therapies that may help treat patients with COVID-19.
"As is true for most medical situations, the great American innovators in academia and industry have engaged with us about treatment options. We are extremely encouraged by the interest and promise in the development of the COVID-19-related therapies. We understand and recognize the urgency with which we are all seeking prevention and treatment options for COVID-19. FDA staff are working expeditiously on that front," said FDA Commissioner Stephen Hahn, M.D. "We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments. At the same time, we will engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply chain pressures. If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it. We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus."
While there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19, there are several FDA-approved treatments that may help ease the symptoms from a supportive care perspective.
The FDA is working closely with innovators in their work to expedite these efforts, including leveraging scientific information about the virus and trials currently being conducted in other countries such as China, Japan, South Korea and Italy as well as in the U.S.
Quickly after the emergence of this virus, the FDA began working directly with partners and innovators to foster the development of medical countermeasures against COVID-19, and we are continuing to provide regulatory flexibility, advice, guidance, and technical assistance. The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. The FDA is able to, and has been, turning around requests very quickly to assist in initiating clinical trials.
For example, last month, the Nationa...
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