The Food and Drug Administration (FDA) has responded to the COVID-19 pandemic by 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 impacts, the FDA reported Friday.
"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 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.
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 lessen the symptoms from a supportive care perspective. The FDA has worked closely with researchers to expedite its efforts, including leveraging scientific information about the virus and trials currently being conducted in other countries.
FDA has continued to provide regulatory flexibility, advice, guidance and technical assistance. The administration will work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate.
The administration’s efforts to facilitate the development of these therapies have been focused on ensuring these medical countermeasures meet the agency's gold standard, relying on data created from adequate and well-controlled trials to quickly determine if an experimental treatment can safely and effectively benefit patients.
In addition, Innovators have looked at products in a variety of areas, including the assessment of antiviral drugs 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 and slow the progression of severe respiratory symptoms.
"We 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,” added Hahn.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.