September 25, 2006
"We found an imbalance in the regulatory attention and resources available before and after approval [of prescription drugs]," said Sheila Burke, chair of the committee that wrote the report. "Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market. Few high-quality studies are conducted after approval, and the data are generally quite limited. Many of the report's recommendations are intended to bring the strengths of the pre-approval process to the post-approval process, to ensure ongoing attention to medications' risks and benefits for as long as the products are in use."
Read more about the report from the Institute of Medicine. (opens in a new browser window)