Letter to The Honorable Andrew C. von Eschenbach, M.D., Commissioner, U.S. Food and Drug Administration

Letter

Sen. Chuck Grassley has asked the Food and Drug Administration to respond to accounts that an agency-convened drug safety oversight board voted earlier this month to keep Avandia on the market by a one-vote margin amid agency considerations of a second warning for the drug label about heart attack risks.

Grassley said sources indicate the board vote occurred on October 2, so he's also asking
the FDA about the terms and conditions governing public notification with this sort of
information.

The FDA first issued a heightened warning about Avandia and heart failure risk in
August, following a May study that appeared in the New England Journal of Medicine regarding
the drug's cardiovascular risks.

"The Avandia case continues to present new rounds of questions about the way the FDA
monitors and assesses drug risks and decides whether to let the public know about emerging
risks," Grassley said.

The text of Grassley's letter follows here.

October 26, 2007

The Honorable Andrew C. von Eschenbach, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner von Eschenbach:

Since May of this year, I have been looking into a matter involving the Food and Drug
Administration's (FDA) handling of Avandia, a pharmaceutical manufactured by
GlaxoSmithKline (GSK) to treat type II diabetes. At that time, the New England Journal of
Medicine published a study that reported a 43% increase in the risk of myocardial
infarctions/heart attacks in people taking Avandia and potentially a 64% increase in the risk of
cardiovascular deaths.

In August, the FDA announced that GSK agreed to add a "boxed" warning on the
Avandia label regarding heart failure risks. According to an article earlier this week by the Wall
Street Journal, the FDA is discussing the possibility of a second "boxed" warning on the Avandia
label-this time for heart attacks. My Committee on Finance (Committee) investigators
learned that the FDA recently convened its Drug Safety Oversight Board (DSOB). It was
reported to the Committee by sources outside of the FDA that, among other things, the DSOB
was asked to vote on the question of whether or not Avandia should be removed from the
market. These same sources stated that the DSOB voted 8 to 7 to keep Avandia on the market.
Among those who voted in favor of Avandia's removal was the Department of Veterans Affairs.

It is my understanding that the DSOB vote took place 24 days ago on October 2, 2007.
To the best of my knowledge, I have yet to see any public notification of this vote. Accordingly,
I would appreciate information from the FDA regarding the internal policies and procedures
governing the DSOB and the terms and conditions governing the release of information from the DSOB to the public.

Thank you for your attention to this important matter.

Sincerely,

Charles E. Grassley
Ranking Member

Source