FDA seeking better data to assess product safety risks

The Food and Drug Administration is working to improve the quality of data used to assess the effectiveness of manufacturers’ risk evaluation strategies.

The federal agency expects to take these steps to improve the quality of data to better assess the benefits of a drug or biological product to ensure they outweigh the risks.

“Today, we’re announcing the availability of two draft guidance documents that will help improve our ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working,” the agency announced in a statement to its regulated entities.

In certain cases, however, the FDA may want additional information or clarity before approving a product and will require completion of a Risk Evaluation and Mitigation Strategy (REMS).



This is a drug safety program that requires additional evaluation of risks by the manufacturer and ensures providers will have all the necessary information they will need to appropriately prescribe or dispense the medication.

Also See: FDA looks to strengthen premarket review of medical devices

This is where enhanced use of data comes into play to complete a REMS evaluation. Guidance from FDA describes how to develop an assessment plan and how the REMS design may impact the types of metrics and data sources that could be used to assess whether the program is meeting the risk mitigation goals that the manufacture and FDA both seek. Certain metrics, for instance, may include the number of patients or providers who are enrolled or certified in the REMS assessment, or the number of prevented fetal exposures to a particular drug.

Other data used to evaluate performance of the assessment include drug utilization data, epidemiological data, surveys of stakeholders, postmarket adverse event data, observational data and stakeholder input.

In additional guidance to the industry, FDA offers tips about assessment knowledge surveys that cover study design, survey data collection, and the processing and analysis of data.

The guidance documents are available here and here.