AstraZeneca proposes FDA review of all drug ads
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AstraZeneca Plc on Tuesday proposed a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer advertising to the U.S. Food and Drug Administration for review prior to its use.
The Anglo-Swedish company said it made the recommendation in written testimony submitted to the FDA’s public hearing on consumer-directed promotion of regulated medical products.
The FDA is considering revising rules about how much risk information prescription drug commercials must include and whether all consumer-directed advertisements must be reviewed before they circulate.
AstraZeneca said it has adopted an industry group’s guidelines on direct-to-consumer advertisements, and the principles are reflected in its TV ads for cholesterol pill Crestor and gastric acid treatment Nexium launched earlier this year.
AstraZeneca has been the subject of lawsuits filed by consumer groups and the AFL-CIO, which alleged the company misled patients into switching to the more expensive Nexium as the patent on its nearly identical, older Prilosec pill was set to expire.
Last year, the company said a U.S. Attorney requested documents related to the formulary status of Prilosec and Nexium.
Crestor has been touted as a multibillion-dollar seller for AstraZeneca, but sales of the medicine have been disappointing due to persistent questions about its safety profile.
Drugmakers are required by law to submit promotions for FDA review at the time of circulation. Some manufacturers voluntarily provide them earlier, but the agency is considering whether that should be mandatory.
The Pharmaceutical Research and Manufacturers of America (PhRMA) in August released voluntary ad guidelines that include plans to voluntarily submit ads to the FDA sooner and to provide more balanced risk information.
The FDA is also considering whether makers of medical devices, most of which currently are not subject to FDA promotional regulations, must submit ads for review and face penalties for misleading or false materials.
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