What is this Alphabet Soup?
What is this alphabet soup?
Written by Li-Anne Rowswell Mufson
REMS- RISK EVALUATION AND MITIGATION STRATEGY.
RIC- REMS Industry Consortium
Although it is reasonably well understood conceptually, the REMS program is relatively new - it started in 2007- and is still in the process of being operationally understood. The reality of multiple Sponsor and Vendor organizations sharing a REMS program can lead to breakdowns in Communication, Collaboration, and Consensus among the different organizations and even the departments within those organizations. With help from Metis' Consultants and with the tools provided by RIC, organizations can work to identify potential issues before they start and prevent communication siloing along departmental and organizational lines; by fostering collaboration and consensus with shared REMS sponsors and vendors.
Evaluation within the REMS program is used to mitigate risks, and the strategy for the Mitigation piece is presented to the FDA. The FDA evaluates for both tactics and strategies.
Because of all the complexities and even some unnecessary complications, staying current and having specialists in this manner is essential. That is the reason the RIC was started.
The REMS Industry Consortium provides education and learning tools to help and standardize the successful execution of an REMS program. Metis is a very enthusiastic supporter of the Consortium as it kicks off.
What is RIC?
The REMS Industry Consortium, Inc. (RIC) is a nonprofit organization made up of industry experts. According to the RIC website, it " brings together the perspectives of organizations that sell—or anticipate selling—prescription drugs or biologics subject to Risk Evaluation and Mitigation Strategies (REMS).”
The RIC seeks to:
Foster and encourage two-way communication between manufacturers/REMS sponsors and FDA
Discuss and clarify challenges faced by industry sponsors and the FDA
identify best practices for REMS throughout the development, review, and management lifecycle
Provide the FDA with a "sounding board" to solicit feedback on REMS
collectively explore vendor participation and capabilities in REMS."
The emphasis is mine. In these areas, in particular, having knowledgeable and experienced consultants from Metis will be invaluable to pharmaceutical manufacturers subject to REMS.
What is REMS?
The U.S. Food and Drug Administration (FDA) introduced the Risk Evaluation and Mitigation Strategies (REMS) program in 2007 to ensure that the benefits of particular drugs outweigh their risks. REMS is a comprehensive strategy pharmaceutical manufacturers must develop and implement to manage known or potential serious risks associated with a specific drug while ensuring continued patient access to the medication.
One key aspect of REMS is the Risk Identification and Analysis (RIA) process, which involves identifying potential risks associated with a drug and analyzing the likelihood and severity of those risks. Based on the RIA, pharmaceutical manufacturers develop a REMS program that includes various strategies to manage and mitigate the identified risks.
REMS programs typically include a combination of elements such as medication guides, communication plans, training and certification programs for healthcare providers, patient registries, and restricted distribution programs. These elements aim to ensure that healthcare providers and patients have access to the information they need to make informed decisions about the pharmaceutical's use and minimize the risks associated with its use.
Pharmaceutical manufacturers must submit a proposed REMS program to the FDA for review and approval before marketing the drug. The FDA reviews the proposed REMS program to ensure that it includes appropriate risk management strategies and is feasible to implement.
Once the REMS program is approved, pharmaceutical manufacturers must implement and maintain the program as authorized. The FDA monitors the implementation and effectiveness of REMS programs through various means such as inspections, audits, and assessments.
Pharmaceutical manufacturers must understand and comply with REMS requirements to ensure that their drugs are safe and effective for patient use. Failure to comply with REMS requirements can result in enforcement action by the FDA, including fines, product seizures, and injunctions.
In summary, REMS is a critical program that pharmaceutical manufacturers must comply with to ensure the safe use of their drugs. REMS requires manufacturers to identify and mitigate potential risks associated with their drugs and implement various risk management strategies to minimize those risks. Pharmaceutical manufacturers should work closely with the FDA throughout the REMS process to ensure that their REMS programs meet regulatory requirements and effectively protect patient safety.
Coming up
In our next blog post, we will discuss the history of thalidomide, the heroic work of Frances Kelsey, and how that eventually led to the institution of REMS.
Metis' CEO, Michelleanne Bradley, has been involved with REMS programs since they began in 2007. For more information about RIC and REMS, listen to Episode 6 of the "Queens of Quality" Podcast. You can also drop us a line at Hello@metisconsultingservices.com or check us out on LinkedIn.
