Call For Increased Drug Safety Monitoring

A group of US drug safety experts has asked the Food and DrugAdministration to set up an independent Center for Drug Surveillance to monitor the country's 3,200 prescription drugs for unexpected safety problems, along the lines of the National Transportation Safety Board.

If half a penny from each prescription written was targeted for such a center, $100 million could be raised, according to Raymond Woolsey of Georgetown University, who noted that an independent center could provide a better early-warning system. As drugs are approved more rapidly, surprise side effects such as those found with the two diet drugs fenfluramine and phentermine (Marketletter September 22 and page 2) will happen more often, said Dr Woolsey.

The FDA agrees that its own drug monitoring system needs improvement; agency drug evaluation director Janet Woodcock says she is very unhappy about the FDA's internal system. This fall, the Med-Watch program will be updated and computerized to improve detection of potential problems, she told AP. Under the current MedWatch plan, which has a $140,000 budget, doctors report side effects voluntarily, and four MedWatch employees then look out for dangerous trends. Drug monitoring is supplemented by 48 employees in another office.