If it ain't broken, don t fix it!

Related articles

An FDA advisory panel s recommendation to pull the breast cancer indication for Genentech s Avastin shouldn t cause the FDA to pull the accelerated approval system along with it, argue ACSH s Jeff Stier and Hoover Institute fellow, former FDA official and ACSH trustee Dr. Henry Miller in an op-ed in today s Los Angeles Times:

It is worthy of emphasis that the vast majority of drugs marketed after accelerated approval are found in subsequent studies to be safe and effective. And given that only medicines for "serious or life-threatening diseases" that address an "unmet medical need" are eligible for this pathway, accelerated approval has offered huge benefits to patients for almost 20 years by making important medicines available far earlier than would otherwise be the case.Amid controversies such as the one over Avastin, we should not lose sight of the fact that accelerated approval works.

Stier and Miller also address an underlying issue Avastin s high price. The drug costs around $8,000 a month, which has led some, including The New York Times, to call for the FDA to consider its cost-effectiveness in addition to its efficacy. Stier says, In this country, there is no place for that. They do that in England, where they ration health care, but cost does not belong in a discussion of risk-benefit analysis and drug efficacy.