On February 27th and February 28th, UBC attended and participated in the Fierce Pharma Drug Safety Summit as a platinum sponsor. The event brought together many industry professionals for a look into all topics related to REMS and Pharmacovigilance. UBC’s Rachael Bonfanti delivered one of the keynote presentations entitled “When to Start REMS Development and How to Create a Contingency Plan” on Day 1 of the Summit.
The event, although heavily focused on REMS, was divided into two tracks: Risk Management & REMS and Pharmacovigilance. The inclusion of these two important topics in the drug development process as part of the Safety Summit was an excellent opportunity for understanding how these two topics come together to achieve best outcomes around patient safety while minimizing risk from the start.
Experts provided information on a range of important topics, with a great focus going to the topics below.
REMS Regulatory Updates
A presentation by the FDA set the tone in discussing initiatives to modernize REMS, as well as sharing updates to the Technical Conformance Guidance and the newly required Structured Product Labeling (SPL) format to make REMS even more standardized. SPL is now underway, as of Dec. 28, 2022, and will bring standardization to the workflow for all REMS stakeholders. It will create ease of use for communicating REMS requirements by facilitating easier information retrieval and integrating REMS in health information systems.
In a follow-up presentation, the Technical Conformance Guidance and PDUFA VII and the role they play in developing a REMS were discussed. The impact and change brought about by collecting Real-World Data (RWD) and Real-World Evidence (RWE) with the Food and Drug Omnibus Reform Act of 2022 (FDORA) was a key topic as well. The strategy of “going in with the end in mind” and asking the question “Are you going in with the right data and collecting it in the right way?” should be a foundation for exploring data collection methods. The discussion was concluded by touching on how changes made by the FDA will impact the industry moving forward.
Common Hidden REMS Costs
Millions are spent on developing REMS programs and the cost may deter some manufacturers from developing REMS. However, ignoring regulations and risks to patients could incur a cost far greater than the cost to develop one. Conducting deep dives into a company’s REMS program can reveal some of the many hidden costs associated with REMS development. Some examples include the cost to fax patient data (such as labs), completing forms associated with prescribing a REMS drug and the follow-up calls associated with monitoring, the production of REMS Patient Guides, and the bulk ordering of these guides.
Creating a cost-effective REMS program upfront – through utilizing available technology and early stakeholder involvement – are key. An average fax costs $20 per page. The use of online enrollment versus enrolling by fax can create substantial savings. Having systems in place for quick and easy form submission, such as phone apps, can assist prescribers with the timely submission of forms and eliminate delays. Delays require sending follow-up emails and create the need for costly outbound calls to the prescriber when email methods are not effective. In addition, the cost involved in printing materials, shipping them out, and storing the materials can be eliminated with the use of QR codes and user-friendly REMS websites that are compatible with multiple devices. Looking at the life of the REMS and investing money on the front end by integrating technologies like these can substantially reduce costs.
Proactivity is Key in REMS
UBC’s Rachel Bonfanti shared her insights on When to Start REMS Development and How to Create a Contingency Plan. Her focus was on three main factors that should be considered when developing a REMS program and contingency planning in the event that a REMS will be needed. The three factors are the motivation for the REMS (whether it be proactive or reactive), timing and using it as a starting point for REMS decision-making, and the components of REMS development, using tools such as the Technical Conformance Guidance to assist in developing the REMS. Rachel also discussed the importance of contingency planning and utilizing an “if, then…” model to guide planning for a potential REMS.
Another panel also discussed contingency planning and getting the FDA involved early in discussions as the potential need for a REMS is discussed. Involving the REMS vendor was listed as a priority as they know the right questions to ask and understand the details presented by the FDA. Further suggestions were to have a REMS strategy for every product, even if the strategy is that the product does not need a REMS, and to draft a compliance plan early as “compliance is the heart and soul of a REMS.”
A common theme throughout the event was that a REMS expert is essential in REMS planning. A REMS expert should have experience with the FDA, regulatory and compliance knowledge, experience with forecasting, prior experience managing a REMS, and understand the importance of the company’s risk tolerance level. Furthermore, having a REMS vendor is also essential to the of development of a successful REMS.
Challenges and Opportunities with Development and Safety Surveillance in LMICs
LMIC is an acronym for Low-and Middle-Income Countries. In developing COVID-19 vaccines, the difficulties with drug accessibility, affordability, and safety were illuminated across the globe for LMICs. There are currently early initiatives to improve on these areas, as well as an initiative referred to as An Accord for a Healthier World being led by Pfizer that has approximately 45 African nations targeted to be part of the pilot as well as Haiti. The program was launched in May 2022 with the vision of bringing needed therapies to LMICs. Some early collaborators include COVAX, Unicef, WHO, Smart Safety Surveillance (3S), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Some challenges with LMIC pharmacovigilance include overcoming trust issues due to a lack of knowledge and or misconceptions about clinical trials due to historical experiences, training resources and knowledge building, access to technology, and reporting tools and harmonization across regions.
Although progress has been made there are still areas of unmet medical needs and opportunities for all of us to be part of the solutions to creating a more global and inclusive world for patients.
UBC’s approach to Safety and Risk Management stems from our epidemiological, multidisciplinary foundation. Our commitment to Patients First has driven us to balance high-tech solutions with a personalized, experienced touch in our services. To start a discussion around our Safety and Epidemiology Consulting, Pharmacovigilance, or REMS services, click here.
About the Authors
Takiya Thomas is a Sr. Project Manager at UBC. With 24 years of experience in pharmacovigilance, Takiya’s years of experience in Pharmacovigilance allows her to maximize her interactions with clients and foster positive relationships and trust.
Malissa Torrez is a Sr. Project Coordinator at UBC in Safety, Epidemiology, Registries & Risk Management. Malissa applies her unique skillset to assist in multiple aspects of REMS development, including creating REMS documents for UBC’s clients.