International Law

AstraZeneca Not Liable For Marketing of Nexium

This posting was written by Jody Coultas, Editor of CCH State Unfair Trade Practices Law.

A group of consumers alleging false advertising in the sale of heartburn medication failed to state an Arkansas Deceptive Trade Practices Act (DTPA) claim against AstraZeneca Pharmaceuticals, Inc. (AZ) because the claim fell within the safe harbor provision of the statute, according to the Arkansas Supreme Court.

In 2001, AZ's medication Nexium was approved by the Food and Drug Administration (FDA) for marketing as a heartburn medication. Nexium was meant to take the place of AZ's other heartburn medication Prilosec when the patent for Prilosec expired.

The consumers argued that AZ falsely advertised its heartburn medication, causing consumers to purchase a more expensive medication that was not "more powerful" and did not actually work "better" than a similar medication, as advertised. At the time of the complaint, one pill of Nexium cost $4.46, while the over-the-counter Prilosec cost $0.59 per pill.

Safe Harbor

The safe harbor provision of the DTPA, which barred the claim, provided that the statute does not apply to advertising that is subject to and complies with laws administered by a federal agency.

In this case, federal law specifically authorized pharmaceutical companies to promote drugs to consumers and physicians in a manner supported by the labeling approved by the FDA. Because the FDA-approved labeling indicated that the approved dose of the medication was superior to the similar drug, the advertising complied with the labeling.

The decision is DePriest v. AstraZeneca Pharmaceuticals, L.P., CCH State Unfair Trade Practices Law ¶31,932.

Full post as published by Trade Regulation Talk on November 28, 2009 (boomark / email).