The US Food and Drug Administration (FDA) has taken a number of actions over the course of the past several days, related to the nation’s COVID-19 responses.
EUA for COVID-19 treatment
The FDA issued an emergency use authorization to Genentech (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
In clinical trials of hospitalized patients with COVID-19, Actemra (in addition to the routine care patients given to COVID-19 patients) reportedly was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased, according to study results.
“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic.”
Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. In the case of COVID-19 infection, the immune system can become hyperactive, which may result in worsening of disease; it does not directly target SARS-COV-2.
Actemra is a prescription medication given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis. Under today’s EUA, the FDA is authorizing the emergency use of Actemra for the treatment of certain hospitalized patients with COVID-19.
Supply chain vulnerabilities
The FDA, Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the White House, the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response has come out with a series of policy recommendations to address vulnerabilities in the country’s pharmaceutical supply chain, created or exacerbated by the COVID-19 pandemic. According to the departments, the report and the recommendations contained therein have been accepted by President Joe Biden.
Acting FDA commissioner Janet Woodcock said, “Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country. Now is the right time to take action to keep the U.S. drug supply chain secure and resilient.”
According to the recommendation document, the country should work toward a robust pharmaceutical supply chain, which has the following features:
- the ability to manufacture high-quality products for the US market
- diversification of the drug supply chain, such as relying on a geographically diverse set of manufacturers
- redundancy of the supply chain, such as the existence of multiple manufacturers for each product and its precursors.
Vaccine tamperer sentenced
A Wisconsin hospital employee charged with trying to ruin COVID vaccine doses at his workplace has been sentenced to three years in prison for his misdeed. The matter had been investigated by the FDA’s Office of Criminal Investigations.
“The FDA has ensured that the Moderna COVID-19 vaccine meets the agency’s rigorous standards for safety, effectiveness, and manufacturing quality; those who knowingly tamper with this vaccine place American patients’ health at risk,” said assistant commissioner for criminal investigations Catherine Hermsen. “Today’s announcement should serve as a reminder that this kind of illicit tampering activity will not be tolerated.”
Unauthorized products
The FDA has not approved any over-the-counter products to prevent, treat, or cure COVID-19. However, that has not stopped a number of companies from trying to sell such products; if caught selling the illicit products, the agency steps in.
The FDA issued warning letters jointly with the Federal Trade Commission to Beauty & Spa Concepts (DBA Beenefits) and Everything Health LLC for selling unapproved products with unproven COVID-19 claims. Also, a company calling itself Umbrella received a warning letter from the FDA telling it to stop selling products with unproven COVID-19 claims.
