(Source: RAPS 2016-06-18）
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.
Background
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, Celgenes 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 programs 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 drugs approval, and are required when FDA determines “that safety measures are needed beyond the professional labeling to ensure that a drugs 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 FDAs 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.
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 theyre 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.
More Information on RAPS