J&J latest target of Grassley probe into ESA pricing, marketing
Pharma Compliance Alert, June 6, 2007
Ranking Senate Finance Committee Member Chuck Grassley (R-IA) is continuing his probe into the safety, marketing, and pricing of erythropoiesis stimulating agents (ESAs). He is looking into allegations that Johnson & Johnson and its subsidiary Ortho Biotech encouraged doctors to prescribe higher doses of the drug anti-anemia drug Procrit before the FDA had approved the dose, reports FDA News. Grassley is also investigating claims of questionable pricing and the FDA receiving "limited access" to clinical trial results.
Grassley has asked the company to provide complete study results and an explanation for why it withheld them. J&J has until June 13 to do so, according to the report.
Last month, Amgen received a similar letter, which requested "a briefing to discuss the issues and concerns reported in the media" related to the marketing and safety of ESAs. Amgen said Grassley requested documents and discussion about data requested by the FDA, Amgen's responses to those requests, and other information regarding clinical trials and adverse events.
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