By Clinical Research News Staff

January 24, 2019 | The US Food and Drug Administration (FDA)’s commissioner, Scott Gottlieb, released a statement today announcing the availability of two guidances that will help improve the agency’s ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working.

In an official statement, Gottlieb says these Risk Evaluation and Mitigation Strategy (REMS) programs can help mitigate the risks and enhance the benefits new drugs and biologics might present.

The guidances, REMS Assessment: Planning and Reporting Guidance for Industry and Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry, provide a framework for companies to develop a REMS Assessment Plan at the same time that the REMS program is being developed. This will improve the quality of the information used to assess the effectiveness of a REMS program, and provide post-market evidence that the REMS is meeting its risk mitigation goals, according to Gottlieb.

“In making decisions about whether the benefits of a drug outweighs its risks, there are many times when a drug provides important benefits, but also has serious risks,” Gottlieb wrote. “In some cases, if there is a greater assurance that those risks can be properly managed, then the benefits can support approval. This is the field of risk management, and it’s a critical function here at the agency.”

The first guidance details how to develop a REMS Assessment Plan by considering how a REMS program’s goals, objectives, and design may impact the types of metrics and data sources that could be used to assess whether it is meeting its risk mitigation goals.

The second guidance draft provides recommendations on conducting REMS assessment surveys to evaluate a patient’s or health care provider’s knowledge of REMS-related information, such as the serious risks and safe use of a medication.

Guidances follow the FDA’s commitment to  continue critical aspects of their work, Gottlieb said, as the agency is currently operating without an appropriation for Fiscal Year 2019.

“At this time, for products covered by a user fee program, such as those under a REMS, our review of existing medical product applications and associated policy development is funded by limited carryover user fee balances,” Gottlieb said. “The FDA will continue to update the public on how we’re approaching our work.”