Commitment to safety and patients: Risk evaluation and mitigation strategies (REMS)
Bristol Myers Squibb is resolutely committed to patients, their families, providers and public health. We firmly believe that our commitment to developing the most effective Risk Evaluation and Mitigation Strategies (REMS) and our unwavering efforts to operate these systems has allowed hundreds of thousands of patients to access our medications while preventing certain serious risks associated with taking such medications. Our commitment to patients extends to ensuring, without exception, that other companies that utilize our products subject to REMS with Elements to Assure Safe Use (ETASU) in clinical testing share our commitment to safety and implement necessary safeguards.
Overview of REMS and ETASU
What is REMS
REMS are patient safety programs required by the U.S. Food and Drug Administration (FDA) that are intended to ensure that the benefits of a drug or biological product outweigh its risks.1 Under the law, a REMS may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Since medicines are very different from each other, any required REMS is also different for each medicine. REMS elements can include a variety of safeguards including medication guides, patient package inserts and communication outreach.2 Additionally, the FDA may require a REMS with more extensive requirements known as ETASU.3 Those elements can include required testing of patients before a medicine is administered, education of pharmacists and dispensing in certain healthcare settings.
| In practice, a REMS program is a safety strategy that manages a known or potential serious risk associated with a medicine and enables patients to have access to such medicines by managing their safe use. |
REMS Programs
ABECMA REMS
BREYANZI REMS
CAMZYOS REMS
Lenalidomide REMS
POMALYST REMS
THALOMID REMS
Related content
Bristol Myers Squibb developed a mobile app as part of a Risk Evaluation and Mitigation Strategy (REMS) that reminds patients when it's time for a required survey and lets them complete it on their smartphones.
References
- FDCA §505-1
- FDCA §505-1(e)(2)
- FDCA §505-1(f)(3)