While the COVID-19 continues to impact professionals in pharmaceutical development, clinical trials and other life-sciences fields, the US Food and Drug Administration (FDA) continues to come out with informational documents, release blogs and podcasts, and take action related to COVID-19. Read below for the highlights of this week’s FDA activities.
The agency released a guidance offering recommendations on what to do if a pharmaceutical manufacturing employee directly involved in drug-making activities tests comes down with the virus. The guidance addresses workers with confirmed infection, typical symptoms or exposure to an infected person.
According to the agency, the recommendations are designed to help companies avoid negative effects on the safety and quality of drugs. Drug manufacturers are expected to evaluate existing manufacturing controls to prevent drug safety or quality issues related to contamination from the virus.
Additionally, the guidance suggests, drug manufacturers should review Centers for Disease Control (CDC) guidance regarding when employees may continue working following exposure or potential exposure to COVID-19. They also should implement procedures to minimize exposure and transmission in the workplace.
While the agency to date has not been alerted to any drugs contaminated with the virus, it still recommends drug manufacturers take precautions necessary to prevent contamination from happening in the future.
The agency launched its debut episode of its FDA Insight podcast. The series will tackle a range of topics of concern to professionals and civilians.
The first episode features commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah discussing drug development processes for a COVID-19 treatment. Upcoming podcast will feature the two men and other leaders discussing COVID-19 and other emerging topics.
Fraudulent COVID-19 products
While the FDA has not to date approved any products to prevent or cure COVID-19, that has not stopped many companies from producing, promoting and selling products that falsely claim to treat the disease. This week, two companies received warning letters ordering them to stop their shenanigans.
- A company called Project 1600 Inc. was cited for making and selling cannabidiol (CBD) products to US consumers, falsely claiming that they can prevent and treat the virus.
- North Isle Wellness Center received a warming letter scolding them for offering their Methylene Blue products, which they claimed effectively could mitigate or treat COVID-19.