FDA Issues Warning Letter for Off-Label Promotion of Drug to Treat COVID-19

The Food and Drug Administration (FDA) recently issued a warning letter to the manufacturer of an approved prescription drug for an off-label use to treat COVID-19 symptoms. Off-label use is defined as an approved prescription drug for unapproved conditions, patient groups, or dosages. While the FDA has previously pursued hundreds of fraudulent COVID-19 products, this appears to be the first warning letter addressing the unapproved use of an FDA-approved drug to treat patients with COVID-19. Currently, there are no FDA-approved COVID-19 products on the market.

The first-of-its-kind FDA warning letter was sent to Nephron Pharmaceutical Corporation regarding Budesonide Inhalation Suspension. The warning letter states that CEO Lou Kennedy and a company sales representative wrongly sent emails to health care providers claiming Budesonide relieves respiratory problems associated with COVID-19. According to the FDA, Nephron represented that “[o]ver the last few weeks, doctors and researchers have touted the benefits of using Budesonide as a treatment for symptoms associated with COVID-19” and that Budesonide is a “[c]ost effective way to treat Coronavirus!” Budesonide is an inhalation suspension indicated for the maintenance treatment of asthma and as prophylactic therapy for children 12 months to eight years old.

“These claims and representations provide evidence that Nephron is promoting Budesonide for a new use for which it lacks approval and for which its labeling does not provide adequate directions for use. Budesonide is not approved as a treatment for symptoms associated with COVID-19, and its labeling does not contain adequate directions for such use, thereby rendering the drug misbranded,” wrote Robert Dean, director for the FDA’s Office of Prescription Drug Promotion, in the letter.

The FDA requested that Nephron immediately cease such off-label promotion. In addition, Nephron was also directed to submit a plan to the FDA to correct the promotion of any unapproved use of its drug.

If you need assistance understanding off-label promotion or FDA warning letters, please contact me.

Leave a Reply

Next ArticleFDA Approves First COVID-19 Drug: Veklury