Drug company proposes FDA check all drug advertising prior to marketing

Nov 2 2005

Drug company AstraZeneca has proposed that it should be 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.

Apparently the Anglo-Swedish company has made the recommendation in letter submitted to the FDA's public hearing on consumer-directed promotion of regulated medical products.

The FDA is presently considering revising the rules about how much risk information prescription drug commercials must include and whether all consumer-directed advertisements must be reviewed before they circulate.

According to AstraZeneca the company 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 which was launched earlier this year.

AstraZeneca has been the subject of lawsuits filed by consumer groups and the AFL-CIO, which allege the company misled patients into switching to the more expensive Nexium as the patent on its nearly identical, older Prilosec pill was about to expire.

A U.S. Attorney last year requested company documents related to the formulary status of Prilosec and Nexium.

Crestor had been promoted as a multibillion-dollar seller for AstraZeneca, but persistent questions about its safety profile have resulted in disappointing sales.

Currently drugmakers are required by law to submit promotional material for FDA review at the time of circulation.

While some manufacturers voluntarily provide them earlier, 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.