FDA COVID-19 responses and recommendations this week
The first wave of US citizens are receiving COVID-19 vaccines in the country’s hospitals, clinics and, in one case, in their cars on a snowy highway. In the meantime, the US Food and Drug Administration (FDA) is maintaining its status as a source of advice for researchers, healthcare professionals, citizens and other affected entities.
The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA's response efforts.
CDER conversation
The agency has posted Center for Drug Evaluation and Research (CDER) Conversation with Katie Gray, Pharm.D., acting director of CDER’s Office of Prescription Drug Promotion (OPDP). In the question-and-answer piece, Gray outlines the office’s COVID-19 response to date, which has centered on focused on compliance actions regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment.
Additionally, the interview touches upon the OPDP’s achievements throughout 2020, such as a multifaceted initiative intended to help support competitive markets for biological products, including biosimilars. Gray also revealed OPDP’s efforts to increase visibility and awareness with industry players, including plans to participate at the upcoming DIA Advertising and Promotion Regulatory Affairs Conference.
Plasma guidance
The FDA updated its Investigational COVID-19 Convalescent Plasma guidance and corresponding webpage. Revisions include updated recommendations regarding the qualification of individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial (or who have received an authorized or licensed COVID-19 vaccine) as convalescent plasma donors.
In addition, the agency has extended the period of enforcement discretion described in the guidance. The FDA first issued an emergency use authorization (EUA) for COVID-19 convalescent plasma for the treatment of patients hospitalized with the virus.
Fraudulent vaccine arrest
An investigation by the FDA’s Office of Criminal Investigations has led to an arrest and filing of a criminal complaint by the US Department of Justice for introducing misbranded drugs into interstate commerce. The investigation found that defendant Johnny T. Stine, as early as March 2020, claimed to have a COVID-19 vaccine, which he offered to inject in customers for up to $1,000. His company, North Coast Biologics, had received a warning letter from the FDA ordering him to cease the promotion and sale of the unapproved, unproven vaccine product.
“Unproven injectable vaccines purported to prevent or treat COVID-19, made from unknown substances under unknown conditions, present significant health risks in and of themselves," said special agent in charge Lisa Malinowski of the FDA Office of Criminal Investigation’s Los Angeles field office. “The FDA will continue to investigate fraudulent COVID-19 treatments and bring to justice those who try to profit from the pandemic.”
