FDA Issues Warning Letter to AstraZeneca Regarding Breztri Aerosphere Promotional Communication

The U.S. Food and Drug Administration (FDA) has issued a warning letter to AstraZeneca Pharmaceuticals LP, addressed to CEO Pascal Soriot, regarding promotional materials for Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol.

According to the FDA's Office of Prescription Drug Promotion (OPDP), a professional sales aid submitted by AstraZeneca contains false or misleading claims and representations about the efficacy of Breztri, thereby misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act. The OPDP specifically took issue with claims suggesting that Breztri treatment has been shown to have a positive impact on all-cause mortality in COPD patients and to significantly reduce severe exacerbations, assertions which are not supported by the trial data cited.

The FDA has requested AstraZeneca to cease these violations and has given the company 15 working days to respond to the letter, outlining a plan to rectify these issues. Failure to adequately address the concerns may result in further regulatory action.

Reference: WARNING LETTERAstraZeneca Pharmaceuticals LP
MARCS-CMS 664789. FDA. August 4, 2023. Accessed August 16, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-08042023