Did FDA counsel save Procrit ads?

Remember that DTC hearing in Congress last week, when Rep. Bart Stupak alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions? Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air.

The agency had questioned J&J's advertising, saying its implication that Procrit improved strength and perhaps survival was misleading. Somewhere along the line, the Office of Chief Counsel became involved; notes from a 2002 teleconference show that the OCC asked the staff to "try to find middle ground" and to avoid "yanking" the ad campaign. (The chief counsel at the time of the teleconference is now in private practice.) The ads continued to run through 2005. Experts told The Cancer Letter that they think the episode should be reviewed by agency ethics officials.

Meanwhile, a Government Accountability Office report shows that the FDA drags its heels on issuing warning and untitled letters about DTC ads: Six months on average, and in one case, more than three years. Before 2002, when the FDA decided to submit all draft letters for legal review--by the Office of Chief Counsel--they went out in less than a month.

- find the GAO report here
- see the brief in The Cancer Letter
- get more from Pharmalot
- check out the article at FDA News

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