Scientific Communications and Medical/Promotional Review

The value of developing scientific content as it relates to the needs of the pharmaceutical industry and the products they market continues to grow. Many of the decisions made by health care providers regarding the use of pharmaceuticals and medical devices regarding their patients’ care comes from information obtained from not only the FDA, but also from colleagues, presentations attended at professional meetings, and other sources of information and recent research findings. This information is imperative for providing the highest level of care for patients.

In the United States, the Food and Drug Administration works with pharmaceutical companies in scheduling product research timelines that may lead to product approval for specific indications, product labeling guidelines, assembling package insert language, the approval of promotional materials and other regulatory guidelines and assistance. Pharmaceutical companies recognize the additional role they must play in keeping drug product information accurate and useful to all segments of health care and consumers. This can be done by working internally or they may outsource some of this work to vendors that employ health specialists who are also medical writers. These vendors are skilled at taking drug product research findings and completing various projects for these organizations. Examples of an increasing number of professional projects provided include:

• Preparing and periodically revising Standard Response Documents (SRDs) that Life Science Organizations approve for distribution to health care providers
• Preparing and updating or revising product-specific dossiers which are used to evaluate the use of new pharmaceuticals
• The preparation of professional slide decks, which may be used for a variety of reasons including sales and marketing meetings as well as internal staff development
• A critical and compliant review of promotional materials that the company has developed for advertising agencies and the media
• Assisting companies with different facets of Publications Planning
• Preparing scientific and nonscientific materials designed for use at professional meetings
• Writing drafts of publications that are intended for regulatory submission to scientific journals
• Assisting with other writing projects for which companies identify specific needs

The FDA, through the Center for Drug Evaluation and Research (CDER), imposes strict regulations on the pharmaceutical industry for every aspect of the drug development and marketing process for products in the United States. To enforce these regulations, the Office of Prescription Drug Promotion is tasked with ensuring that accurate, fair-balanced, and non-misleading information is presented in Prescribing Information and medical or promotional advertising materials.

As part of the medical, legal, and regulatory (MLR) review process for medical and promotional materials, reviewers must critically evaluate content in written, audio, and video materials for accuracy and compliance with regulatory requirements. They ensure all presented data and claims made about the drug are backed by substantial evidence from clinical trials that are reviewed by the FDA. Specifically, medical review of materials involves taking an in-depth look at values and data points reported in clinical trials to ensure accuracy and consistency across both promotional and non-promotional medical materials. Another critically important goal of medical review is to ensure that all efficacy claims are balanced with appropriate safety information. While the balance between regulatory compliance and the need for effective communication of product information in medical and promotional materials is a delicate one, it can certainly be achieved with the right review services.

Med Communications’ Scientific Content team is highly experienced at collaborating with a wide variety of pharmaceutical clients to ensure that reviewed materials are compliant, comprehensive, and engaging. Our team can serve as subject matter experts who provide strategic day-to-day oversight of medical and promotional materials review operational activities. We are also highly skilled at reviewing with the attention to detail needed to sift through materials that influence the safe and effective use of products and overall patient health.

Med Communications has many years of experience supporting clients with medical and promotional review services. Our review services are classified into three categories that can be tailored to fit your company’s unique needs.

• General reference review, approval, and formatting: Our team can help support your company and agency partner’s content creation and update activities for medical and promotional materials by reviewing, vetting, and formatting newly added references. This will ensure that the most current references, obtained from high-quality, reputable sources, are presented in all materials according to your standards.
• Medical quality assurance (QA)/fact check review: Our medical reviewers can actively engage in the MLR review cycle for your projects and focus on the intricately detailed task of fact-checking data points alongside references to ensure accuracy and consistency across all materials. This results in increased efficiency of your MLR review process and significant cost savings for your company.
• Dedicated medical reviewer: Our dedicated medical reviewer can be seamlessly integrated into your medical team, providing leadership and strategic input for planning and support for all operational activities associated with the medical and promotional materials review process.