FDA required post-market trials are also different ethically than comparative-effectiveness research, Faden points out. For the latter, the medical establishment truly does not know what intervention works best and for whom, as opposed to testing something that they suspect might be causing harm against an alternative.
Pulling a therapy from the market without testing is also undesirable, Faden points out, because "sometimes the worries are unfounded," or the intervention proves perfectly safe for a particular set of patients.
The FDA, which requested the IOM begin its analysis in 2010, said in response to the report that it is "currently engaged in developing a systematic process for assessing and communicating new information about a drug after it is marketed," according to a prepared statement from the Center for Drug Evaluation and Research released this spring. The statement (to which FDA representatives referred comment requests) does not make specific reference to whether the agency will take into account the IOM's recommendations.
The FDA also has ethical obligations to use the data from these post-market trials that it requires, Faden and her colleagues argue. She acknowledges that the agency already faces huge resource challenges and that overseeing additional ethical controls could be a strain. But she projects that if it could reduce the chances of future trials ending like the one for Avandia did, it would ultimately be an efficient long-term investment.
The bottom line on which both the FDA and the IOM agree is that there needs to be better, more transparent tracking of drug safety throughout a product's development, release and use. Just because a treatment gains FDA approval does not mean that it is ultimately safe or even safer than older options. "There's no line in the sand that magically happens," Faden says. "We keep learning about drugs over their lifetime."