As I see it
For FDA-watchers, the timing is right. As its parent department again tops George Mason University's annual least-transparent government department list, the FDA's own performance continues to fall short of repeated promises to be more transparent about its drug decisions.
The Department of Health and Human Services was the lowest-ranked of 24 federal agencies evaluated by the Mercatus Center at George Mason University. Their report shows the HHS on a steady downhill slope since 2001, when then-secretary and now presidential candidate Tommy Thompson stripped agencies like the FDA of any residual independence they still had.
Last year, his successor Michael Leavitt vowed to make the HHS, including the FDA, more transparent. So far, the main evidence of this might be a sentence from Leavitt's HHS biography: “He is intensively focused on making healthcare more transparent…”
FDA commissioner Andrew von Eschenbach repeatedly makes the same commitment, but it eludes him just as much. Even as his agency was refusing to explain why it canceled without notice a long-scheduled but closed meeting of its Anti-infective Drugs Advisory Committee, von Eschenbach was on the NPR Diane Rehm Show agreeing with its host that “there seems to have been a breach of trust” in the public's faith in his agency.
But a week later his Press Office was still refusing to say whether the FDA had investigated data integrity issues at three clinical study sites at which the agency found “problems” before Sanofi-Aventis' Ketek was approved.
Transparency? Easy to say, hard to do.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).