OIG report finds REMS program wanting

March 15, 2013

FDA is receiving insufficient information and has limited authority to enforce REMS, says OIG report

FDA approved 99 Risk Evaluation and Mitigation Strategies (REMS) to reduce the risk for particular drugs between the program’s inception in 2008 and 2011.


A recent report that evaluated the operation of the REMS program during those years, issued by the Office of Inspector General (OIG) and titled, “FDA Lacks Comprehensive Data To Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety,” indicated that because some sponsors have not submitted sufficient assessment information, FDA can’t know how well many REMS are working.

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

Questionable effectiveness
“Our findings raise concerns about the overall effectiveness of the REMS program,” the reviewers wrote in the report, adding that “FDA has not identified reliable methods to assess” the effectiveness of REMS, and noting that FDA does not have authority to require manufacturers to submit specific effectiveness information.


They noted that they had made seven recommendations in connection with 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 that are not meeting goals and the need 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 is posted at the OIG website. For a quick way to get there, use this URL: www.drugtopics.com/rems/oig.


FDA’s list of approved REMS appears at its website. You can get to it with this URL: www.drugtopicscom/remslist.