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House committee seeks FDA communications from J&J, Amgen

Pharma Compliance Alert, June 20, 2007

The probes into anemia treatments continue, this time with the U.S. House Energy and Commerce Committee requesting advertising documents from Amgen and Johnson & Johnson. According to a letter to HHS Secretary Michael Leavitt, the committee is requesting information about inserts in packages of Aransep and Procrit that included "unapproved quality of life claims."

The committee requested records of communications between the companies and the FDA relating to advertising of the drugs and the "quality of life" claims. Although the FDA in March called for label changes, the committee says it wants to find out what took the agency so long to correct the labels and put an end to "misleading advertising."

Earlier this month, Ranking Senate Finance Committee Member Chuck Grassley (R-IA) began investigating allegations that Johnson & Johnson and its subsidiary Ortho Biotech encouraged doctors to prescribe higher doses of Procrit before the FDA had approved the dose, as well as claims of questionable pricing. He also cited allegations of the FDA receiving "limited access" to clinical trial results. Grassley asked the company to provide complete study results and an explanation for why it withheld them.

Last month, an Amgen SEC filing said that it received a letter from the Senate Finance Committee "requesting a briefing to discuss the issues and concerns reported in the media" related to the marketing and safety its anemia drug.

Click here to read the letter to Leavitt on the U.S. House Energy and Commerce Committee's Web site.

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