FDA updates and actions on COVID-19
The US Food and Drug Administration (FDA) continues to keep itself busy with legislation, rulings and guidances issued in relation to the nation’s COVID-19 response. Many of these actions and advisements impact professionals in the pharmaceutical and clinical trial fields.
Friday, after bipartisan cooperation, US President Donald Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The $2tn (€1.8tn) emergency relief bill is intended to both aid response efforts and lessen the overall negative economic impact of the pandemic.
Provisions of the legislation include $80 million for the FDA’s COVID-19 response efforts, including support for the development of tests, vaccines and treatments. This component is designed to accelerate the development and distribution of products to fight the virus.
The legislation also includes a section designed to change the way a number of over-the-counter (OTC) drugs are reviewed and approved. According to the FDA, the law grants the agency new and broader authorities in reviewing and approving monograph drugs, including acetaminophen, hand sanitizer, and other products used to prevent and treat COVID-19.
The CARES Act also includes a section requiring pharmaceutical manufacturers to draw upon multiple sources for key product ingredients, to prevent shortages of active pharmaceutical ingredients (APIs) used in products for the treatment of COVID-19, as well as other conditions.
The passage calls upon manufacturers to “maintain contingency and redundancy plans, as applicable, for each establishment in which such drugs or active pharmaceutical ingredients of such drugs are manufactured to help prevent or mitigate interruptions in the supply of the drug or ingredient.”
Other recent actions and announcements by the FDA include recommendations on sample collection from potential COVID-19 patients, issuance of emergency use authorizations (EUA) for diagnostic tests, and categorization of cancer patients as immunocompromised.
Additionally, in mid-March, the FDA issued a guidance designed to advise clinical trial sites and sponsors. The advisory document provides suggestions intended to increase the safety of, and minimize risks to, patients, staff and other involved individuals.
