While pharma firms and their partners continue to work diligently on vaccines and treatments for COVID-19, the US Food and Drug Administration (FDA) continues to serve as a resource, providing information and guidance.
The FDA updated its guidance regarding investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021.
This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the emergency use authorization (EUA). The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.
Treatment development update
The agency updated the dashboard on its Coronavirus Treatment Acceleration Program (CTAP) webpage. The resource is intended to provide current information about the agency’s special emergency program to help develop treatments for COVID-19.
As of October 31, more than 560 drug development programs stood in planning stages, more than 370 clinical trials had been reviewed by the FDA, five COVID-19 treatments were authorized for emergency use, and one treatment was approved by FDA for treatment of COVID-19.
Many manufactures of consumer products have received warning letters for making and selling items purported to prevent, treat or cure COVID-19; to date, the FDA has not authorized or approved any such products to deal with the virus. The agency recently took more severe action at a flagrant violator of the rules.
The US Department of Justice (at the request of the FDA) filed a civil complaint in the US District Court for the District of New Jersey against Natural Solutions Foundation and two individuals associated with the entity. The complaint is directed at Rima Laibow and Ralph Fucetola, seeking to permanently enjoin them from distributing Dr. Rima Recommends Nano Silver 10PPM in interstate commerce as a prevention or treatment for COVID-19 and other diseases.
The next possible step, if the defendants are found to be in continued violation, would be to go to trial. At that point, the government could pursue a permanent injunction against them.