FDA continues to facilitate development of COVID-19 treatments
Custom Synthesis, 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.
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