Once again, we have a split vote from an FDA advisory panel asked whether a drug is too risky to stay on the market. The FDA's handpicked experts voted eight to six to two on Abbott Laboratories' obesity drug Meridia: Eight for withdrawal, six for restricted sales and a "black box" warning, and two for the warning plus close monitoring of patients.
So, just as with the Avandia panel vote--which split among withdrawal, restrictions, warnings and no change at all--the FDA has no straightforward advice to go on. The agency will have to weigh to panel's findings with its own data, along with Abbott's various ideas for risk management.
The Meridia decision isn't a bank-breaker for Abbott; the drug is expected to bring in only $100 million in global sales this year, with less than $30 million sourced in the U.S. But it's considered an indicator not only of the agency's attitude toward weight-loss drugs in general, but toward overall drug safety.