OIG examines overall effectiveness of FDA's REMS program



The Department of Health and Human Services Office of Inspector General (OIG) has reviewed 99 Risk Evaluation and Mitigation Strategies (REMS) approved by FDA since the program’s inception in 2008 through 2011.

In its recent report, titled “FDA Lacks Comprehensive Data To Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety,” the OIG indicated that because not all sponsors had submitted assessment information, FDA can’t know how well many of the REMS are working to reduce the risks associated with certain drugs.

Requirements under REMS may include information for patients, providers, and pharmacists about the safe use of a drug, or stipulations that providers, including pharmacists, be trained or certified to prescribe or dispense the drug.

According to the report, FDA identified 22 deficiencies that may interfere with a REMS’ effectiveness, which “included low patient exposure to medication guides, low understanding of risk messages among patients and/or prescribers, and poor compliance with the REMS among healthcare providers.”

Reviewers looked at 49 sponsors’ REMS assessments and found that for nearly half, the sponsors had not submitted all requested information. In addition, FDA said, only seven of those 49 had met all their goals.

Nineteen of the 49 assessments had required elements to assure safe use (ETASU); of these, only one had met all its goals. ETASUs are required of drugs with potentially serious side effects and have the most extensive elements of a REMS program.

“Our findings raise concerns about the overall effectiveness of the REMS program,” the reviewers wrote in the report. 

They noted that they had made seven recommendations concerning FDA’s evaluation and assessment of REMS and its review of sponsors’ REMS assessments. FDA agreed with most of the recommendations, including the need to identify REMS not meeting goals and to take necessary action. The agency said it would consider pursuing legislative changes in connection with its authority to require manufacturers to submit specific information on REMS effectiveness.

The report can be found here.

FDA’s list of approved REMS appears on its website.  

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