Yesterday, the GAO released the report from their investigation into how the Food and Drug Administration went about rejecting the application requesting over-the-counter status for the morning-after pill, and it’s even more damning than most thought it’d be. The GAO went through all 68 applications filed between 1994 and 2004 for conversion of a drug to over-the-counter status, and found that the FDA used entirely different criteria in its determinations on emergency contraception than it had on the other 67 applications. Likewise, the FDA had never before ignored the recommendations that came from its own internal scientific review committee, and top management had never before involved itself to the extent it did in the Plan B decision. And then, there’s my favorite part: there’s good evidence that the rejection decision was made by the same high-level management officials even before the scientific review committee concluded its work. It’s a shining example of politics getting in the way of healthcare; while the FDA has issued a statement questioning the integrity of the GAO’s investigative process, it’s pretty clear that that’s just the agency’s way of expressing its anger about being caught cheating. Sad.
Nov 15, 2005 | Government | Medicine