Gathering data on post-approval drug safety and on how to mitigate identified risk are essential for reducing drug-related morbidity and providing quality health care more generally. Current law entrusts the conduct of these activities, which are vital to public health, to a for-profit industry whose revenue would be threatened by prompt, competent, and transparent assessment of and education about the risks of approved medications. That so much of the industry’s work in this area is slow, low quality, or in some cases even non-existent is not surprising. The Commission recommends a fundamental change in approach: direct governmental control over post-approval drug surveillance and of the development, implementation, and evaluation of risk evaluation and mitigation strategies is needed.
Congress must decide where in government these activities are based, but to avoid conflicts of institutional interest they should not be overseen by FDA’s Office of New Drugs, which generally sees its charge as bringing more medications to market. The funding and authority to monitor and mitigate post-approval drug risks -- including the power to pull an approved drug from the market if warranted -- could be given to drug safety officials within the FDA, or, as some have proposed, to an independent agency outside of the FDA.