This from the Forbes blog by Matthew Herper. He writes that handling of the Avandia situation by the US FDA may signal their desire to avoid mass market drug recalls ala Baycol, Vioxx and Zelnorm (that one hit my family) for a more surgical approach.
The FDAAA legislation gave the FDA the new risk evaluation and mitigation system (REMS). Using REMS, the FDA can really really really restrict the use of a drug without killing it altogether. That way, if a medication is a last resort for a proportion of the population, they potentially can use it after satisfying criteria that all other medications won't do the job for them. And, these patients will be fully informed and/or supervised in proper use of the medicine. Big Brother to some. But, not as draconian as complete removal of the medication.
Avandia will now be sold in the US under these type of severe restrictions. GSK says that after the restrictions are implemented, Avandia's annual sales will be "minimal". Minimal > nothing. And, only those patients in dire need of this specific drug will be able to use it. Seems like a reasonable balance between safety and true need. And, this helps explain why Avandia is still on US market while it has been withdrawn from Europe.
Currently, 146 products have approved REMS. Of these, 96 include only a medication guide, 33 include a communications plan requiring additional steps to get a patient approved to use, and 15 have "elements to assure safe use". Avandia falls into the latter class - which explains its extremely limited expected use in the future. The FDA now has more precise tools to protect safety. REMS can be expected to be more commonplace in the future and mass withdrawls are likely extinct.
Posted by Bruce Lehr September 24th 2010.