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FDA warns pharma over misleading web ads

The FDA has issued warning letters to 14 pharma companies over misleading information in sponsored links on search engines

The US Food and Drug Administration (FDA) has issued warning letters to 14 pharma companies after routine monitoring found sponsored links on major internet search engines containing misleading information about drugs.

Routine monitoring and surveillance by the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the FDA discovered that several pharmaceutical companies are using platforms such as Google and Yahoo to advertise their products in the form of sponsored links. DDMAC claims these links are misleading as they fail to communicate any risks associated with the use of the product. In some instances, the omission relates to advertised drugs that carry Boxed Warnings.

Several of the adverts contain links to websites dedicated to the products; however, DDMAC said that the link "is insufficient to mitigate the misleading omission of risk information from these promotional materials".

The letters also highlighted that by failing to use the required established name, pharma companies were in breach of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.

In the letters, dated March 26, DDMAC has requested that each company ceases to publish promotional materials, such as those outlined in the letter immediately. The pharma companies concerned have until April 9, to submit a written response stating whether they intend to comply with the request, listing all promotional materials in use for each affected product, identifying the promotional materials that violate the regulations and explaining their plan for discontinuing the use of such materials.

7th April 2009

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