Watch The Congressional DTC Hearing Right Here!!

Yes, we are trying something new today. With the enormous interest in DTC ads, in general, and the controversies surrounding the Lipitor and Vytorin advertising, in particular, we thought you would enjoy watching the hearing as it takes place.
Not only that - special just for you - we are including another feature that allows [...]

Lights, Camera, Scrutiny: Congress & DTC Ads

Want to know the full story behind those famous Bob Jarvik ads for Lipitor? How about the rationale for heavily promoting Vytorin? Then tune in next Thursday May 8 to the House Energy and Commerce Committee hearing on direct-to-consumer advertising. It promises to be a good show.
The subcommittee on Oversight and Investigations is chaired by [...]

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 [...]

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 [...]

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 [...]

What Makes Bart Run… After Pharma & The FDA

The Democrat from Michigan, who chairs the House Energy & Commerce Committee’s Subcommittee on Oversight and Investigations is busier than ever. He’s probing the FDA’s handling of Baxter’s Heparin, the blood thinner linked to hundreds of patient reactions and four deaths; TV ads for Pfizer’s Lipitor; the release of Vytorin clinical-trial data by Schering-Plough and [...]

Andy: FDA Responded To Heparin With ‘Alacrity’

In his weekly note to FDA employees this afternoon, FDA Commish Andy von Eschenbach writes agency staffers with an update on the Heparin affair - you know, the Baxter blood thinner linked to 350 side effects and four deaths. The active ingredient is made in a plant in China, which the FDA never inspected. Given [...]

Congressman To FDA Commish: ‘Resign’

Bart Stupak, who chairs the House subcommittee on Oversight & Investigations (pictured left), has had it with Andy von Eschenbach. In the wake of probes into the Ketek antibiotic and a failure to inspect facilities connected to the side effects and deaths linked to the Heparin blood thinner, the Democrat from Michigan wants Andy’s head.
And [...]

Congress Probes J&J And FDA On Stents

Not long ago, stents were a hot business. Lately, though, the little devices are causing Johnson & Johnson big trouble. Studies released earlier this year questioned their safety due to blood clots, causing sales to decline sharply. In fact, stent problems were cited as a key reason for J&J’s recent decision to eliminate more than [...]

New PDUFA Safety Amendment On Its Way

Bart Stupak, a Michigan Democrat and a member of the House Energy and Commerce committee, tomorrow plans to offer an amendment to the House drug safety bill that would create joint authority for the Office of New Drugs and the Office of Suveilance and Epidemiology, according to sources.
The effort mirrors a recommendation by the Institute [...]

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