The latest debate over Roche's Avastin--whether the FDA should yank its approval for breast cancer use--shows how pulling a drug off the market is a lot more complicated than keeping it off the market to begin with.
Avastin got the breast cancer nod under the fast-track approval program based on just one study showing it staved off tumor growth for about five months. Now, the company has come back with required follow-up studies--two trials that suggest Avastin keeps tumors at bay a month and a half, rather than five. The FDA's advisory committee reviewed the data and voted 12-1 to revoke the indication; the agency is set to decide by Sept. 17.
That's how the program is supposed to work. If a drug proves less effective than initially thought, the FDA does an about-face. But in practice, the very suggestion that the FDA would revoke that approval has patient groups and opportunistic politicians up in arms. Not to mention Roche, which is lobbying to keep the indication.
Cost is key. The FDA isn't supposed to consider cost, and the advisory panel billed its decision as a risk-benefits analysis, with Avastin's apparently diminished benefit on one side and its not-inconsiderable side effects on the other. But if the indication is lost, insurers likely won't pay. And everyone knows--even the FDA advisory panel--that Avastin is a pricey treatment. Whether the FDA's final decision is tainted by the cost question, if it follows the committee's recommendation, it will be accused of "rationing."
At least some patient advocates aren't pulling at those heartstrings. "The FDA should never have approved Avastin for breast cancer to begin with," Fran Visco of the National Breast Cancer Coalition tells the Washington Post. "We don't see evidence of benefit, but we do see evidence of harm."
- read the Post piece