New bill would give FDA more drug safety oversight
Two senators introduced a bill that would give the Food and Drug Administration more authority to monitor the safety of new prescription drugs.The bill would require pharmaceutical companies to agree with FDA on a "Risk Evaluation and Management Strategy," which would include an annual review of new medications over three years. Also under the bill, pharmaceutical companies would have to file with FDA 15-day, quarterly and annual reports on adverse events related to new medications.
Sens. Michael Enzi (R-WY) and Edward Kennedy (D-MA) introduced the bill. Drug safety has been a key issue at the agency and among policymakers. In April, the Government Accountability Office recommended the agency create a better system of tracking post-market safety issues.