Pharmas Market with Mike Huckman

DNDN's Provenge And GSK's Avandia: In FDA Spotlight

As a big FDA Advisory Committee meeting is taking place here in Gaithersburg, Maryland on the safety of GlaxoSmithKline's Avandia, the head of the agency has been named in a separate lawsuit. A non-profit group calling itself "CareToLive" is suing FDA Commissioner Dr. Andrew von Eschenbach over the recent delay in the potential approval of Dendreon's Provenge.

An FDA spokesperson says the agency doesn't comment on pending litigation.

The lawsuit accuses the Commish of "arbitrarily and capriciously" denying immediate approval of Provenge and putting the lives of tens of thousands at stake.

The plaintiffs want a federal judge in Ohio where the case was filed to order the drug be made available right away. The suit also names Health and Human Services Secretary Mike Leavitt, another FDA staffer, as well as a controversial doctor who was on the outside panel that reviewed Provenge.

CareToLive calls this action unprecedented. What else would you expect from the most hotly-debated, dramatic drug approval pathways I've ever seen?

Avandia Update
Meantime here at the Gaithersburg Holiday Inn so far team Glaxo has briefed the Advisory Committee. Over and over and over again the company reps said the data are inconclusive and inconsistent and that the drug doesn't have an increased risk of heart attacks.

The FDA is up next. And then later today the panel will vote on the cardiovascular risk and whether it warrants Avandia being pulled from the market. Stay tuned.

Crunch Time for Glaxo

Questions?  Comments?