FDA WARNING_LETTER - Nephron Sc Inc - September 22, 2020

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Nephron Pharmaceuticals Corporation regarding promotional emails for Budesonide Inhalation Suspension. The emails, sent by a company employee and a sales representative in July 2020, were submitted as complaints to the FDA Bad Ad Program.

The FDA found that these emails promoted Budesonide for an unapproved new use: treatment of symptoms associated with COVID-19. This renders Budesonide misbranded under 21 U.S.C. 352(f)(1) and 331(a) because its labeling lacks adequate directions for this use. For example, one email prominently claimed, "BUDESONIDE RELIEVES RESPIRATORY SYMPTOMS ASSOCIATED WITH COVID-19," and another linked to a video discussing "treating COVID patients successfully with Budesonide."

Furthermore, the emails were deemed false or misleading under 21 U.S.C. 352(a) & (n) and 321(n), and 331(a) because they presented benefits without including any risk information about the drug. Budesonide is only approved for maintenance treatment of asthma and prophylactic therapy in children 12 months to 8 years. The FDA emphasized the public health concern due to the misleading impression created about Budesonide's safety and effectiveness for COVID-19, especially given the lack