Jul
05

7 Essential Considerations about Promotional Material Review and Approval

business-gear-to-success-20933774Promotional material review has become an important topic because of increasing scrutiny of pharmaceutical advertising by Regulatory Authorities, Public and Media across the world. Dissemination of promotional materials and engagement in activities that are promotional in nature is a part of business practice of pharmaceutical and biotechnology companies. Promotional materials target either consumers or health care professionals and are disseminated on different types of media. Surveillance and enforcement of prescription drug advertising is governed by country Regulatory Authorities (i.e. FDA in US, Federal Legislation in Russia, etc).

To ensure that promotional materials and activities comply with industry guidance and local regulations, pharmaceutical companies normally establish promotional review committees, which are cross-functional teams that take into account legal considerations and review medical consistency. The medical reviewer normally resides in Medical Affairs or Medical Information department. The basics of medical promotional review are more or less common among established and emerging countries since they are based on global corporate requirements. Below are the some most essential principles of promo-material review and approval in pharma and biotech manufacturers.

1. Promotional review committe has to be established and it’s work should be governed by a corporate procedure with clear distribution of responsibilities. Normally it’s representatives are from Regulatory, Legal, Marketing, Medical Information and Medical Affairs. Review and approval process may be virtually performed in a corporate on-line system with access for all assigned roles.

2. The prescription drug advertising and promotion regulations require promotional materials to be fair-balanced and not false or misleading in the communication of benefit and risk data. Promotional content must be consistent with the prescribing information as approved by local regulatory authorities.

3. Promotion and advertising of a product prior to marketing authorization (registration) is prohibited. Information on unapproved drugs and indications (off-label) may be given to physicians only by the Medical Affairs function and only upon unsolicited request from physician.

4. Promotional content must be substantiated by reference to prescribing information as approved by local regulatory authorities or by additional scientific evidence meeting the requirements of local regulatory authorities. Such additional evidence should be made available to physicians upon request.

5. Medical Information responsibles ensure scientific relevance, accuracy and completeness of clinical data, as well as that claims are adequately supported by data and materials are consistent with current approved label. The acceptability of references used to support claims should also be determined.

6. Medical literature quotations must not change the meaning intended by the author or the significance of the underlying work or study.

7. Normally pharmaceutical manufacturers require that promotional material should include:
– trade name and generic name of the product;
– name, logo and address of the company marketing the product;
– short statement with essential product characteristics including safety data;
– date of production and a unique identifier.

Reference

1. Bork L., et al. The role of pharmaceutical medical information in promotional review: three benchmarking review. Drug Information Journal, 2012; 46: 107-114.

Written by Dr. Alexander Tolmachev, alexander.tolmachev@gmail.com

Written by Dr. Alexander Tolmachev. Posted in MSL News