Institute of Medicines new drug safety recommendations
- FDA should create a benefit and risk assessment and management plan for each drug
- This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market
- The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product’s use, as well as benefit and risk assessments specific to these questions
- It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions
The Institute of Medicines, the evidence-based advisory committee for policymakers, health professionals, the private sector, and the public has released a press release with advice for the improved oversight of drug safety of marketed medicines by the FDA.Drug safety is critical throughout the lifecycle of a drug but the increasing size, time length and diversity of the patient pool when a drug hits authorisation can throw some unexpected adverse events up. The IOM recommendations are for a more systematic and transparent process to collect, assess and respond to data about the benefit risk profile of a drug in the post marketing stage. This is already required through a number of documents but these recommendations suggest a more accessible format in a single document. The aim of this would be to demonstrate FDA’s commitment to improving transparency for better public access. The recommendations are:
