REMS: Why We Can’t Be Hasty When It Comes to Drug Safety
To be, or not to be? When it comes to drug safety, it is up to the U.S. Food and Drug Administration (FDA) to decide if a medication may be, or not be. The Risk Evaluation and Mitigation Strategy (REMS) requirement was set up by the FDA for select prescription medications which pose a high potential for serious adverse effects. As its name suggests, the REMS program is concerned with drug safety and in ensuring the benefits of a certain drug outweigh the risks1. REMS does not only oversee adverse effects alone, but seeks to “prevent, monitor and manage” any medication the FDA expects could potentially violate safe medication practices1. Although the FDA is in charge of determining whether REMS must be enforced for a medication, it is the manufacturer who is in charge of the program and submission of assessment reports for quality improvement or assurance efforts2. Below is a helpful guide provided by the FDA which can be very useful if you ever find yourself counselling a patient on a REMS classified drug.
Drug safety efforts and their importance in public health can be seen as early as 1937. The antibiotic sulfonamide would result in hundreds deaths due to the toxic excipient diethylene glycol, supposedly claimed as being inert (you can read more about the incident via the June 1981 issue of the FDA Consumer magazine titled “sulfonamide disaster”)3. Later in the 1960s thalidomide was used for antiemetic effects in pregnant women, but resulted in severe teratogenic adverse effects made clear when babies were born with missing or deformed extremities3.
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The difference between these two events, however, is significant from the perspective of the United States. You see, after the sulfonamide tragedy the FDA mandated the 1938 Food, Drug, and Cosmetic Act (FDCA). At this point, pharmaceutical companies were required to conduct actual studies proving a drug is safe before becoming readily available to the general public (which was exactly why sulfonamide slipped through the cracks)3. So thalidomide was never actually approved in the United States due to data suggesting deformities on animal models despite lobbying and immense political pressure against the clinical director at the time3.. As such, the unfortunate teratogenic effects seen with thalidomide were mitigated on home soil. This brief dive into history barely scratches the surface on the importance of drug safety and pharmacovigilance but is helpful in understanding what can happen if we get a little too hasty when it comes to drug safety. As such, this brings us back to REMS. You can view a list of all current REMS medications on the FDA website alongside their associated goals, materials and a comprehensive timeline of program updates for each REMS medication. Additionally, if you want to go really deep into the U.S. regulations for REMS please visit this PDF slidedeck created by the FDA.
- Center for Drug Evaluation and Research. “Risk Evaluation and Mitigation Strategies (REMS).” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
- Center for Drug Evaluation and Research. “FAQs about REMS.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/frequently-asked-questions-faqs-about-rems.
- Alshammari, Thamir M. “Drug Safety: The Concept, Inception and Its Importance in Patients’ Health.” Saudi Pharmaceutical Journal, vol. 24, no. 4, 9 May 2014, pp. 405–412., doi:10.1016/j.jsps.2014.04.008.
- “A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS.” U.S. Food and Drug Administration.