Drug safety and FDA impartiality in the spotlight this week
This week, once again, FDA’s ability to impartially assure the safety of medicines was called into question. A call by Sen. Grassley for the HHS inspector to investigate whether FDA officials collaborated with Merck to squelch criticism of Vioxx by David Graham was the latest blow. It seems that a memo from Brian Harvey (Director of the GI Division in the New Drug Office) to Merck’s Ned Braunstein (Sr. Director at MRL primarily responsible for communicating Vioxx safety information) suggests that FDA was advising Merck how to confront Graham’s charges. Not smart. It’s no secret that many staffers in the new drugs office deem Graham to be a loose cannon, but they need to remember which team they play for. Grassley intends to remind them. In related news, 15% of 1,000 respondents to a survey of FDA personnel conducted by the Union of Concerned Scientists indicated that they had been “asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.” The initial FDA response was to call the survey findings misleading.
Don’t be surprised to see some personnel shake ups in the new drugs office this fall.
In related news, on Tuesday, Sens. Kennedy and Enzi released a draft bill that would give FDA power to alter labels in response to emerging postmarketing safety information. It would also create a Drug Safety Oversight Board to mediate disputes between sponsors and FDA.
