Quote Of The Week: Skinning An FDA Commish

The chairman of the House Energy and Commerce Committee made his stinging remarks yesterday at a hearing held to review FDA oversight. As The RPM Report notes, Dingell (to the left) lost his patience with FDA commish Andy von Eschenbach, who once again refused to say how much money the agency needs to do its [...]

FDA Taking A Slow Boat To China: Congress

Members of a House Energy and Commerce Committee subcommittee chastised FDA commish Andy von Eschenbach today for not doing more inspections of foreign drug makers in the wake of the Heparin scandal and problems with numerous other products, the Associated Press reports.
“Last year, this nation’s regulatory failures resulted in dead dogs and cats. This [...]

Andy’s Take: We Care About Conflicts Of Interest

In his weekly equivalent of a fireside chat, FDA commish Andy von Eschenbach last Friday shared his thoughts about advisory committees and conflicts of interest. You may recall this is a hot-button topic because FDA critics say the agency is too soft on panel members who have some financial tie that may sway their thinking. [...]

The Man Who Would Overhaul The FDA

He’s an elected official in Washington DC, who regularly skewers this or that drugmaker with letters seeking all kinds of info. His hearings can be eventful. And his press releases don’t mince words. Who is he? If you guessed Chuck Grassley, Bart Stupak or Henry Waxman you could be forgiven. But in a piece by [...]

The Provenge Anniversary: A Plea From A Patient

The ongoing controversy over the Provenge prostate cancer vaccine is now one year old, and some of the prostate cancer patients and investors in Dendreon, which is developing the vaccine, are commemorating the saga by taking out full-page newspapers ads. The missives, which are sponsored by Care To Live, a non-profit that has filed a [...]

FDA Commish: The Agency ‘May Fail…Peril Exists’

And Andy blames it on too many responsibilities and not enough funding. In a speech yesterday, von Eschenbach worries that the FDA “may fail in its mission to protect and promote the health of every American. Peril exists. (The agency must be) stronger, bigger and better” to continue as “the world’s gold standard as a [...]

FDA Drug Chief Janet Woodcock Is A Change Agent?

In a rare out-of-character moment, the usually unflappable FDA commish Andy von Eschenbach bristled at a question during an appearance last week at the American Enterprise Institute. Apparently, he took umbrage at the suggestion that naming deputy commish Janet Woodcock to run the Center for Drug Evaluation and Research was simply an attempt to return [...]

FDA Commish: ‘Oh Yeah, Those Provenge E-mails’

One month after a non-profit group accused the FDA of violating the Freedom of Information Act by failing to provide documents, the agency has forked over paperwork indicating FDA commish Andy von Eschenbach did hear from two panel members who last year urged him not to approve the Provenge prostate-cancer vaccine.
The non-profit, Care To Live, [...]

HHS Secretary Maneuvers To Avoid Contempt

For the second time this month, members of Congress are fuming at Mike Leavitt for failing to turn over briefing documents subpoeaned by the House Energy and Commerce committee. The documents were used to prepare FDA commish Andy von Eschenbach for his appearance before lawmakers last year, when he insisted the agency didn’t use a [...]

FDA’s Andy von Eschenbach: In His Own Words

Under fire from all quarters - pharma execs, politicians, consumer advocates, patient groups and investors - Andy is now trying to deflect the criticism in a strategic interview with The Wall Street Journal. The silver-haired, lasso-tongued physician (who talks about ‘deliverables and measureables’) and Bush family friend may realize his job is more daunting than [...]

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