Analysis shows post-marketing studies ignored

A new analysis shows that two-thirds of the post-approval drug trials promised by drug developers have never been started. Only a handful of the trials are designated as delayed because the FDA never actually specified a timetable. In many cases, developers promised to undertake post-marketing studies in order to gain an approval. The FDA has known for some time that it has a problem when developers never begin trials that were agreed to. The new emphasis on pharmacosafety has already prompted the agency to study the situation. It would appear that the hands-off approach of the past will soon become history.

- here's a New York Times article [1]