We are pretty excited around here at Metis. In just a couple of weeks, Metis President/CEO Michelleanne will be traveling to BOTH the SQA (Society of Quality Assurance), 7th Global Conference in National Harbor, Maryland, and then the And the RIC Annual Meeting (REMS Industry Consortium).
What is this alphabet soup?
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 sponsors and vendors.
What is RIC?
The REMS Industry Consortium, Inc. (RIC) is a nonprofit organization made up of industry experts. From the RIC website, they “bring 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 throughout the development, review, and management lifecycle
- Provide the FDA with a “sounding board” to solicit feedback on collectively explore vendor participation and capabilities in REMS.”
The emphasis is mine. These areas, in particular, are where having knowledgeable and experienced consultants from Metis will be invaluable to manufacturers of pharmaceuticals that are subject to REMS.
What is REMS?
The U.S. Food and Drug Administration (FDA) introduced the Risk Evaluation and Mitigation Strategies 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.
The 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 program to ensure that it includes appropriate risk management strategies and is feasible to implement.
Once the 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 requirements to ensure that their drugs are safe and effective for patient use. Failure to comply with requirements can result in enforcement action by the FDA, including fines, product seizures,
and injunctions.
Summary
In summary, REMS is a critical program that pharmaceutical manufacturers must comply with to ensure the safe use of their drugs. It 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 programs meet regulatory requirements and effectively protect patient safety.
Coming up
In our next blog post, we will discuss the history of thalidomide and 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 it began in 2007.
Listen to Episode #6 of the “Queens of Quality” Podcast for more information about RIC and REMS.
Or drop us a line at Hello@metisconsultingservices.com or check us out on Linkedin and our website’s contact page here, metisconsultingservices.com
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