Regulatory Focus™ > News Articles > FDA Unveils New Website Improvements to Help Industry Keep Track of REMS

FDA Unveils New Website Improvements to Help Industry Keep Track of REMS

Posted 17 June 2015 | By Alexander Gaffney, RAC

FDA Unveils New Website Improvements to Help Industry Keep Track of REMS

The US Food and Drug Administration (FDA) is making it easier to find information about the controls that police the use of some of the most dangerous drugs approved for use in the US.


Those controls, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risky products that might otherwise not be approved for use.

For example, Celgene's Thalomid (thalidomide) is a cancer drug intended to help patients diagnosed with multiple myeloma. However, the drug, which was originally marketed as a morning sickness treatment, is also infamous for causing horrific birth defects and fetal deaths. To ensure that multiple myeloma patients could obtain the drug without putting pregnant women at risk, Thalomid is controlled by a REMS (the "S.T.E.P.S." program) which includes counseling about the risks of the drug, required pregnancy testing for females, required contraception and a ban on sperm donation for males and required regular surveys of patients taking the drug. Patients who fail to complete or consent to any of the REMS program's requirements are not permitted to obtain the drug.

These heavy limits on the use of the drug, known as Elements to Assure Safe Use (ETASU), are generally the most restrictive elements of any REMS plan. However, not all REMS plans are as restrictive. Other REMS elements used to account for the risks of a drug include communication plans, Medication Guides (MedGuides) and implementation plans.

REMS are generally approved by FDA at the time of a drug's approval, and are required when FDA determines "that safety measures are needed beyond the professional labeling to ensure that a drug's benefits outweigh its risks." The plans are developed by the sponsor of the drug being approved, and then modified or approved by FDA.

Some drugs may have REMS applied to them after approval, such as if FDA becomes aware of new safety risks or if FDA determines that all drugs in a particular class of products should be subject to the same REMS plans (e.g. extended-release and long-acting opioids).

New Improvements

Previously, if you wanted to find a REMS plan on FDA's website, you encountered a clunky database which made it difficult to either find a REMS or determine when a REMS had been updated to reflect new information.

No longer.

On 17 June, FDA unveiled a suite of new improvements to its REMS pages meant to make it easier for industry users to find the information they're looking for.

For example, users can now easily find all REMS guides containing a medication guide with the click of a button (or communication plan, ETASU or implementation system). In addition, users can sort the list of guides by the date they were last updated as well as the brand name of the drug subject to a REMS.

Users may also download a complete list of REMS guides, as well as historical data, in a structured data format.


FDA REMS Website

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