After years and an immense amount of work across your organization, the time for product approval and market authorization is in sight. This is the opportunity for your product to reach the public and positively impact patient care.
Among the critical activities to undertake at this lifecycle stage is development of medical information response documents, including Standard Response Letters (SRLs) and Frequently Asked Questions (FAQs). These are needed for medical information teams to provide meaningful, accurate, and timely answers to customer questions.
While the creation of these materials may seem daunting amongst the myriad of other launch preparation activities, planning and oversight of the project can help ensure your team is ready to go with materials on hand at the time of approval.
Identify Major Steps/Activities
While processes and procedures may vary slightly between organizations, the major steps/activities in a medical information response document creation project include:
- Develop SRL topic and FAQ list
- Identify and allocate resources (human capital, SRL/FAQ source materials)
- Initial document drafting
- Document review and revision
- Approval (both the product and SRLs/FAQs)
Create a Timeline
A clear timeline is a vital tool to develop as it helps define expectations and allows for ongoing monitoring of project progress. Choose an overall project length sufficient to meet your goals, taking into account human resourcing needs and volume of documents to be created. A 9 to12-month period is often sufficient to allow for document drafting, initial review, revisions, and final review/approval. The timeline should include key time points and milestones to achieve (e.g., initial project launch, completion of 1st drafts, expected regulatory approval decision, etc.). Gantt charts can be a powerful way visualize your timeline for sharing with your immediate project team and other interested stakeholders. Applications including Microsoft Project, PowerPoint, and Excel can be used to create Gantt charts.
Develop a Standard Response Letter Topic and Frequently Asked Question List
Successful response documents will answer the most common question and provide clinically meaningful information to customers. While some amount of guess work is involved, consider the following to help generate a list:
- What questions were received pre-product approval?
- What questions or signals are other functional teams seeing?
- Medical science liaisons, advisory boards, clinical development (trial site investigators), commercial
- Are there unique considerations for the product?
- Serious safety implications (e.g., boxed warning), product preparation, administration
Standard Response Letters (SRL)
Standard Response Letters are valuable for topics which are more complex, data heavy, and longer in length. Commonly requested information ideal for SRLs include general efficacy profile, general safety profile, dosage/administration, and extended storage and stability.
As a full copy of the approved product labeling will be included along with any SRL provided, consider if product labeling information needs to be within the SRL itself. Without labeling information directly in the SRL body this allows for document globalization which more easily facilitates use in other markets and reduces document maintenance. If labeling information is to be included, consider organizing the SRL with the labeling information in its own to discrete section to simplify the adaptation of its use in other country markets where labeling information/requirements may vary.
Frequently Asked Questions (FAQs)
FAQs are valuable for topics which can be addressed more succinctly. These can be used for teams to handle questions received via phone and to create ad-hoc written responses. Consider questions about ingredients/allergens and comparisons to similar or competing products (assuming no direct head-to-head comparison studies were done, otherwise this may be suited for an SRL).
Upon receipt and announcement of product approval, not only will customers have medical questions, but they are going to have a high interest in obtaining the product, so consider non-medical questions like availability. Include information for your team to provide availability information or direction for appropriate triaging (e.g., customer service).
To avoid duplication consider leaving out topics and information which have an SRL or are covered directly within the approved product labeling. This helps limit the number of documents to update in the event a regulatory labeling change occurs or new data related to an SRL becomes available. Your team will have knowledge of available SRLs and access to the approved product labeling, so FAQs should supplement, and not duplicate, those materials.
Identify and Allocate Resources
The number and complexity of documents will be the primary driver of your core team needs and structure. Responsibility for drafting and revising documents can vary and may be done by the product sponsor, sourced to a partner vendor, or a hybrid of the two. The final review and approval should sit with the product sponsor.
Identify and track down the source materials for your team to draw information from for document creation. Consider materials such as:
- Published data: peer-reviewed scientific articles, medical and scientific congress materials (abstracts, posters, presentations)
- Internal data: clinical study protocols/reports, manufacturing information (ingredient/allergen information)
- Other publicly available data: company press releases, online clinical trial listings
Document Creation and Review
The bulk of project time will be spent on creation, revision, and review of documents. After initial drafting a peer level review can be helpful before going on to the more formal and rigorous review process (e.g., cross functional review [legal, pharmacovigilance], medical materials review committee). Following review, revisions can be made accordingly and then re-reviewed.
As material content is dependent in at least some way by the final approved product label, documents cannot be totally finalized until the regulatory approval and label contents are available. Once the final approved labeling is available a final cross-reference can be done to ensure language is appropriate and consistent.
Routine Core Team Check-Ins
Consider setting up recurring check-ins with the core content creation team over the project course to keep things on track. Check-ins help monitor progress, establish team rapport, and allow for collaborative discussion. Frequency of check-ins will vary based on team personality and stage of the project (e.g., closer to the approval decision the more frequent check-ins may be needed).
If your team has an upcoming product approval, ProPharma Group has medical writing expertise across various therapeutic areas to support the building of your response document library to facilitate a smooth launch. To learn more about our services and how we can assist, contact us today.
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