FDA Staff Efforts To Issue Warning Letters On Procrit Ads Were Stopped By Counsel

From The Cancer Letter, May 9, 2008:

Internal FDA documents show that the agency made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s erythropoiesis-stimulating agent Proctit (epoetin alfa) improved “fatigue” associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into the biggest-selling class of oncology drugs, was allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel became involved in the controversy.

The details of the doomed effort by FDA staff to modify the Procrit campaign emerged in the documents that were placed in the public record at the May 8 hearing of the Subcommittee on Oversight and Investigation of the House Committee on Energy and Commerce.

Click on The Cancer Letter Archive at left to download the May 9 issue (subscription required).
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tags: FDA