The American College of Physicians released a new policy paper (pdf file) this week that criticizes the FDA's ability to approve and monitor new drugs, and makes recommendations for improvement.
One was to stiffen requirements for drugmakers to report adverse events after drugs are approved and on the market. Excerpt:
Despite (the current) requirements, it has been estimated that only 1% of all adverse drug events and 10% of serious adverse drug events are reported. Critics of the current system have pointed to the inherent conflict of interest in asking the industry to monitor its own drugs, an issue which is magnified by the intense direct-to-consumer advertising and promotional efforts directed toward physicians, especially during the initial and product launch phases.
And then, on the issue of direct-to-consumer drug ads, the paper recommends:
Grant the FDA the authority to require that newly approved drugs have a special symbol on their labels to help increase public awareness that they are new, and limit direct-to-consumer (DTC) advertising for the first 2 years after approval.