The Promotional Review Process
The pharmaceutical and life sciences industry is highly regulated. Through the Center for Drug Evaluation and Research (CDER), the FDA regulates all pharmaceutical products in the United States. CDER has strict regulations for every aspect of the development and marketing of drugs, from drug manufacturing to product labels to promotional materials. The FDA’s Office of Prescription Drug Promotion (OPDP) is specifically responsible for ensuring that the information presented in prescription drug advertising and promotional materials is accurate, balanced, and not misleading.
During the medical, legal, and regulatory (MLR) review of promotional materials, also called the promotional review process, reviewers evaluate written, audio, and video marketing materials for accuracy of information presented and for compliance with regulatory requirements. They ensure that all claims made about the drug are supported by substantial evidence from clinical trials that have been submitted to the FDA. Reviewers will also make sure that all efficacy claims are balanced by appropriate safety information.
Reviewers ensure that any adverse effects included in promotional materials are accurate representations of those reported during the clinical trials. They also verify whether any new or unexpected side effects should be added.
The balance between regulatory compliance and the need for effective promotional materials is a delicate one, but it can be achieved with the right medical promotional review services.
An effective review service will provide you with a group of experienced reviewers who will work collaboratively to ensure that your materials are compliant, comprehensive, and engaging. An expert reviewer will know what to look for in your materials and will be able to provide actionable advice that helps you make necessary changes without sacrificing the effectiveness of your marketing plan.
Med Communications now offers Medical Affairs and Commercial Review services to assist with your review responsibilities. Our expert team of consultants is here to ensure your promotional pieces are medically accurate and reviewed promptly.
Our medical promotional review services are divided into three categories tailored to your company’s individual needs.
- General reference review, approval, and formatting. As your agency partners are creating or updating promotional materials, new references are always being used. Our reviewers can take the responsibility of reference review, vetting, and citation formatting off of your internal medical reviewers. Our team ensures the proposed references are the most current versions available from high-quality, reputable sources that align with the standards you expect. We also format citations based on your preferred style.
- Medical quality assurance (QA)/fact check review: This process incorporates our review team member(s) into the review cycle of your projects either through a stand-alone account or as a delegate of the internal medical reviewer. Our review team will complete a medical QA/fact check review prior to your internal personnel’s review of the asset. This review will focus on the minute details that may slow down the review process for your internal reviewers: verifying all data points in text and in charts, graphs, and figures (including titles, legends, axes, and footnotes); checking links and anchors to verify all items are accurately supported and referenced appropriately; and verifying that all references are accurately cited and formatted per your guidelines. This process has some flexibility and can accommodate most specific review needs you may have.
- Dedicated medical reviewer: The dedicated medical reviewer can represent your medical team in the promotional review or MLR committee meetings. This reviewer will be responsible for all the same tasks/meetings that are required for your internal medical reviewers and can be fully integrated as a member of the promotional review team/committee.
The team at Med Communications provides high-quality and dependable medical review of your promotional materials. Contact us today to discuss your promotional review needs!