The Drug Safety and Risk Management Advisory Committee meets on its own to consider safety and risk management topics of general interest to FDA, drug development, and public health. But the DSRM also meets jointly with other Advisory Committees to consider specific safety and risk management issues related to bringing new products to market. Such joint meetings signal that the FDA is focusing on one or more concerns related to setting a safety precedent or exploring risk management options in order to improve the benefit-risk profile of a proposed therapy.
In addition, current and former DSRMAC members are often appointed to serve as Temporary Voting Members for therapeutic area approval hearings. There they lend an expert voice to panel discussions of risk management or safety as well as to deliberations regarding product approval in their specializations.
In 2011, DSRMAC current and former members were involved in about 25 percent of Advisory Committee meetings held to discuss drug products; in 2012, close to 50 percent.
What seems clear is that many approval meetings are discussing risk management and scrutinizing potential safety issues, so consideration of and experience with the DSRMAC is crucial for NDAs, briefing documents, and all other communication with the FDA.
Many AdComm preparations require the planning and communication of specialized safety topics and risk management plans, including REMS in general and ETASU (Elements to Assure Safe Use) in particular. More often than not, ECG is preparing teams and their experts to emphasize the virtues of their proposed risk management to protect the public and tilt the benefit-risk balance more positively. The presence of safety and risk management perspectives is becoming the rule. Even AdComms considering products without safety signals get into the topic.
ECG has worked with most of the worldwide experts to define safety issues and develop risk management plans and has helped these experts communicate both for scores of sponsors.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming DSRMAC meeting.
