FDA Broadens Genentech Probe

14 November 1994

The US Food and Drug Administration has widened its investigation into Genentech's marketing practices to include Activase (anistreplase; t-PA). In August, the FDA informed Congress it was looking into Genentech's promotion of its growth hormone product Protropin (Marketletter August 22).

Activase and Protropin account for the bulk of all of Genentech's 1993 sales, according to the Wall Street Journal. The probe into Activase promotion is already underway, with a House of Representatives subcommittee looking into the scientific conduct of the 41,000-patient GUSTO study, which contradicted results of earlier studies such as ISIS-3, which showed that t-PA was no more effective than the much-cheaper streptokinase. Kirk Raab, president and chief executive at Genentech, said that the company was cooperating with the FDA, but that it was suffering simply from what may have been an over-aggressive strategy.

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