Looks like final agreement on FDA bill pushed off Posted by Liz at 08/02/07 02:55 PM

It's disappointing that conference committee has not been scheduled yet, after the Senate in May and the House more recently passed drug safety reform measures. A conference committee is now needed to work out differences in the bills and it was expected that one would convene before summer break.

Actions by an FDA advisory committee this week illustrate why its so important that a final bill is sent to the President soon:

The FDA committee voted 22-1 to keep Avandia on the market and 20-3 that evidence shows the drug adds to the risks of heart attacks. The panel was seeking to resolve questions raised by a May 21 report in the New England Journal of Medicine that linked the medicine to a 43 percent increased risk of heart attacks.

Advisory committee members said they weren't convinced evidence from studies supported pulling the drug off the market, even if the pill increases a patient's chances of heart attacks. They said heightened warnings should help doctors.

Two FDA safety officials argued for removing Avandia from the market. They said the treatment raised cardiovascular risks for diabetics, whose chances of developing heart complications are already elevated. The officials also said continuing studies would probably never remove doubts about the product.

Congress should not delay any longer fixing our broken drug safety system. This kind of unfinished business can put patients' lives at risk.

comments (1)

1 Posted by Amanda at 08/17/07 03:20 PM

If there is even the slightest doubt that someone could die from Avandia, it should be taken off the market. I am shocked to hear that the FDA committee does not feel that way.