The FDA has taken steps to do something it hasn't done much of in the past--maintain more of an open-door policy where key drug and enforcement information is concerned. FDA commissioner Margaret Hamburg has created a task force to make recommendations on such releases, with a report due from the task force in six months.
In the past, the FDA has been locked up tightly, bound under strict confidentiality rules that, among other things, protect information submitted by pharmaceutical companies and medical devicemakers to get approval for their products.
One of the hottest issues faced by the task force is how to handle unpublished clinical data it receives from drugmakers. Sometimes, this research may give early indications that a drug or device is dangerous, but nonetheless, such research is not generally released.
Not surprisingly, the drug industry has said that it's leery of this plan, arguing that the disclosure pendulum could swing too far, undermining new medicine development.
To learn more about the task force:
- read this Associated Press piece
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