Risk Evaluation and Mitigation Strategies (REMS) is a type of safety report designed to monitor any drugs “with known or potential risks.” The report must provide comprehensive data that shows a drug’s benefits outweigh their risks. Each REMS must be reviewed and approved by the Food and Drug Administration (FDA). The FDA implemented this strategy to create a structured system of managing certain drugs. Drug manufacturers are required by the FDA to submit REMS for specific drugs that require additional monitoring due to the potential risk for adverse events. However, the administration has been under fire recently by the Department of Health and Human Services (HHS) with regard to REMS. The HHS is concerned that the FDA is not collecting enough “comprehensive data” to properly monitor REMS and assure the public’s safety.


In 2007, the Food and Drug Administration Amendments Act (FDAAA) provided the FDA with a new set of provisions that allotted an expansion of the administration’s authoritative power. Under the new conditions of the FDAAA, the FDA was given the authority to enforce a new level of risk management.

The FDA may request REMS for any drugs deemed a potential risk. However, the FDA does not have the authority to demand manufacturers to “submit specific information regarding REMS’ effectiveness,” but a request can still be made. Drug manufacturers are required to submit REMS within 120 days for a drug already on the market, with an FDA review timeframe of 60 days. A new drug requires that the REMS be submitted with the drug’s New Drug Application (NDA). Every submitted REMS should include anticipated goal(s), the drug’s intended use, and a concise outline of the drug’s components with regard to safety and efficacy.


Is the REMS program effective?


The HHS/OIG assessment titled “FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety” lays the groundwork for what needs to be done in order to effectively adhere to the FDA’s REMS requirements. The program is effective if the FDA:

  1. Identifies and takes action on REMS that are not meeting their goals
  2. Identifies missing information from sponsors and requests a complete assessment
  3. Clarifies expectations and timelines of REMS for sponsors


The FDA requires a REMS for both new drugs and drugs that have already been approved. New Drug Applications require a preapproval REMS. Preexisting drugs, already on the market, require a postapproval REMS. The FDA follows specific guidelines to determine whether a REMS can be approved, including: the population size of the patients taking the drug, the severity of their condition, the anticipated benefits vs risks ratio, and the length of time patients were receiving treatment.

Recently, the HHS/OIG analyzed data from REMS that were approved by the FDA from 2008 to 2011 to determine if the REMS program is effective. The OIG reviewed the FDA’s assessment of 199 approved REMS, including 74 preapproval REMS and 125 postapproval REMS, and 49 sponsors’ REMS. Of the 199 REMS approved, 99 of them were still being requested as of 2012. Out of the 49 sponsors’ REMS, more than half were incomplete, 10 were not submitted within the allotted timeframe, and only 7 achieved their goal(s). The FDA concluded in their assessment that “review times exceeded its goal of 60 days for all but one sponsor assessment.” After reviewing the data, the HHS/OIG stated: “Our findings raise concerns about the overall effectiveness of the REMS program.”


As of today, there is no concrete evidence to conclusively determine whether REMS are effective. The HHS/OIG claims that the REMS program has been ineffective due to “lack of valid data.” Recommendations for advancing the program such as improving communication with sponsors and identifying goal(s) have been submitted to the FDA for consideration.

For more information on this issue, contact the Kulkarni Law Firm.