FAQs about
Frequently Asked Questions about REMS
1. What is Risk Evaluation and Mitigation Strategy (REMS)?
REMS is a risk management plan that the US Food and Drug Administration (FDA) may require from the applicants. REMS may be implemented to the drug products with serious safety concerns to help ensure that the benefits of these products outweigh the risks.[1]
2. Which type of drug products require REMS?
The FDA may require REMS for any type of prescription drugs and biologics including generic prescription medications depending on the risks, but it is not required for over-the-counter (OTC) medications.[2]
3. In which stage of life cycle, a drug requires REMS?
REMS can be required before or after approval of the drug following post-marketing use of the drug.[3]
4. Who develops REMS?
The product’s manufacturer is responsible for the development and implementation of the REMS program. This can either be developed by the manufacturer or vendors on behalf of the manufacturer. In some cases, manufacturers can also collaborate with other manufacturing companies for shared system REMS.[4]
5. What are the elements of REMS?
There are different tools that are used in a REMS program, these generally include:
- Medication guide or patient package insert
- Communication plan
- Elements to assure safe use (ETASU)
- REMS implementation system[5]
6. What is ETASU?
ETASU are required as part of a strategy to mitigates specific serious risks listed in the labeling of the product. It may also be required if other REMS elements are not sufficient to mitigate a serious risk. These are medical interventions and/or measures required for healthcare professionals to execute prior to prescribing or dispensing the drug to the patient.[6]
7. What is a single, shared system (SSS) REMS?
A SSS REMS is owned by innovator or lead applicant and is also required under the legislation for abbreviated new drug application (ANDA) and the reference listed drug (RLD) to minimize the burden on the healthcare system of having multiple REMS for multiple products of the same class.[7]
8. What are the requirements from REMS applicant?
REMS applicant is required
- to develop and provide REMS training,
- to develop and disseminate REMS communications materials,
- to develop systems and processes to support REMS operations,
- and to ensure participants’ compliance with the REMS[8].
9. What are the timelines for assessments of the effectiveness of the safety measures available in REMS?
The REMS assessment is to be done at least by 18 months, 3 years, and in the seventh year after the REMS is approved.[9]
10. What are REMS assessment plan and REMS assessment report?
REMS assessment plan begins during the REMS design phase with the development of a clear risk mitigation goal and a safety-related health outcome.[10]
REMS assessment report needs to be submitted by manufacturers to the FDA following the REMS approval at periodic intervals.[11]
11. What is REMS dashboard and its benefits?
REMS Dashboard is a web-based platform, which was launched on December 17, 2021. The aim of this dashboard is to improve access to the data for certain drugs with serious risks that need added obligations to ensure safe use. REMS dashboard is available to public and other stakeholders, allowing efficient access and visualization of the REMS data to improve transparency for the FDA drug safety programs [12],[13].
12. What is REMS compliance program?
REMS compliance program provides instructions for conducting inspections of applicant holders and contractors working on their behalf and recommending associated advisory and judicial enforcement actions, as appropriate.[14]
13. What is REMS registry?
An organized system that collects clinical and other relevant data for a population defined by a particular disease, condition, or exposure in a standardized format.[15]
Published on: Oct 11, 2022
References:
[3] https://www.fda.gov/media/105565/download
[5] FDA Basics Webinar: REMS Overview (greengriffith.com)
[6] Approved Risk Evaluation and Mitigation Strategies (REMS) (fda.gov)
[7] https://www.fda.gov/files/drugs/published/Presentation–Development-of-Shared-System-REMS.pdf
[8] https://www.fda.gov/media/108481/download
[9] https://www.fda.gov/media/105565/download
[10] REMS Assessment: Planning and Reporting Guidance for Industry (fda.gov)
[12] REMS Dashboard – About (fda.gov)
[13] Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard | FDA)
[15] Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry: Draft guidance. (Available at: https://www.fda.gov/media/154449/download)
