REMS is a recent and emerging regulatory requirement for all pharmaceutical companies, whereby the FDA expects these companies to monitor, submit plans, and proactively manage any and all safety risks in the sphere of their companies’ operations.  REMS stands for Risk Evaluation and Mitigation Strategy required for pharmaceutical and biotechnological companies.  Common REMS issues include drugs with abuse potential, risk of Qtc prolongation, drug-drug interactions, drugs with the risk of hepatotoxicity, just to name a few.  These risk management programs may also include elements to assure safe use, a proper implementation strategy, assessment tools, and a clear timetable for the submission of assessments.

A REMS report is required for any pharmaceutical and biotechnological company that has been notified during an FDA review, that their products will require preliminary safety testings, because of stricter FDA safety concerns.  Simply stated, REMS testing is the method in which the FDA will balance expedited approval for new beneficial drugs, against the potentially serious side effects that might occur from the drug once they are widely distributed.  REMS testing can range from periodic assessments of different products post-marketing safety profile to limits on prescribing the drug, to a complete removal of the drug from the marketplace.

Because of recent safety concerns from possibly dangerous drugs such as Accutane, some industry experts, including many pharmaceutical consultants, foresee that in the not too distant future, almost every single approved product will have some form of REMS testing or another.  Because of more public awareness about possibly dangerous drugs being widely distributed, many public safety groups, as well as the federal government are starting to question whether a package insert containing important safety information is enough to ensure public health.  Many feel that additional safety measures need to be taken.

There are a number of different conditions in which a risk evaluation may be required.  One of the most common circumstances is when new safety information becomes available about a drug that might result in further testing of the drug’s overall safety.  The FDA might also require that if a group of medications all have the same risk, then those from that same drug class be tested as well.  The FDA may also require a risk evaluation test on new medications if there is any concern about any potential side effects.  New safety information may be defined as any information that might be derived from a clinical trial, adverse event reports, post-approval studies, or any other scientific information that may have emerged.

If your pharmaceutical company is expecting a REMS review, the most important thing you can do is to develop a strong REMS strategy to counter your upcoming inspection.  The best way to do this is to contact a pharmaceutical consultancy firm that specializes in preparing pharmaceutical companies for REMS inspections just like these.  They can help to give you the knowledge and the confidence to take any REMS inspection head on.

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