FDA Needs Better, Ongoing Approach to Drug Risk-Benefit Assessments, IOM Says

The FDA needs to take an ongoing, lifecycle approach to assessing the risk-benefit profiles of new drugs and should seek more public input during the process, a new Institute of Medicine (IOM) report urges. To this end, the agency should create and maintain a publicly available benefit and risk assessment and management plan (BRAMP) for each new drug, and for potentially risky treatments already on the market, it states. But the FDA will be hard pressed to bring this and other suggestions to fruition soon. Attempting to implement the BRAMP recommendation on current resources could seriously compromise other critical regulatory endeavors, the agency said Tuesday.
Drug Industry Daily