AstraZeneca CEO Pascal Soriot hit with FDA warning letter—based on “misleading” claims

This:

Dear Pascal Soriot:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a promotional communication, a professional sales aid (US-68433), for BREZTRI AEROSPHERE™ (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use (Breztri) submitted by AstraZeneca under cover of Form FDA 2253. The sales aid makes false or misleading claims and/or representations about the efficacy of Breztri. Thus, the sales aid misbrands Breztri within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and makes its distribution violative. 21 U.S.C. 352(a); 331(a). Cf. 21 CFR 202.1(e)(5). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the overall benefits a patient may expect as a result of Breztri treatment.

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