A few weeks ago, the FDA announced the beginning of a pilot program to issue "report cards" to keep closer tabs on the side effects of new drugs. Coming in the wake of the 2004 Vioxx recall, the program is a response to a report by the Institute of Medicine that criticized the FDA's drug safety tracking. Several senators proposed legislation to form a separate group within the FDA to track already marketed drugs on February 8.

These developments reminded me of an article I read a few months back that looks at the complexities of balancing the need to safeguard the public from potentially harmful new drugs with the desire to market potentially lifesaving treatments as soon as possible. The article also examines whether patients with terminal conditions should have unlimited access to experimental drugs. Pretty fascinating—though labyrinthine—issues.

The Right to a Trial
FDA Proposes Report Cards
FDA Approval Process Explained

Flickr photo by confusedvision (cc)