Since Congress helped the FDA and the drug industry reach a deal in 1992 to guarantee drug reviews would be completed within six months to one year for life saving medicine, it has been reported that the culture at the FDA has shifted toward valuing speed over safety. The 1992 deal required annual reports to Congress listing review times but did not require reports regarding the agency's safety assessment of drugs approved to be on the market. Several drug-safety officers have been punished or discouraged for recommending strong warnings on drugs, causing some of these officials to leave the agency. Those who have left the FDA have suggested that Congress should require the FDA to make regular public assessments of the safety of approved medicines, act on reports of drug problems promptly and require regular reports on the agency's adherence to these goals.

Last month, the Senate passed a bill to overhaul the FDA to include more financial support for drug-safety assessments and require an advisory committee to meet twice a year to consider safety issues.

By registering as a free member, you can access the full press report at: