Prescription drugs to be scrutinized more closely under new legislation

The Senate on Wednesday voted 93-1 to approve a bill S. 1082 that would reauthorize the Prescription Drug User Fee Act. The legislation includes a number of prescription drug safety provisions, such as a provision that would establish a computerized network to scan public and private health insurance and pharmacy records for indications of safety issues with new medications. The legislation would require the Food and Drug Administration to actively monitor the safety of drugs on the market and require pharmaceutical companies to develop plans to manage any serious risks associated with new medications. A companion bill has yet to be considered in the House. The legislation's underlying purpose was to renew, through 2012, a program that has the drug industry pay fees to the agency to defray the cost of reviewing new medicines.

Drug companies would be required to do follow-up studies on certain medicines or risk fines. The FDA could require label changes for drugs. An active surveillance program would replace the largely passive way the FDA now learns of potential problems with drugs on the market. It calls for the mining of federal and private databases that log side effects in tens of thousands of patients. The final bill does allow for fines for ads that are false or misleading.