A medicine is a chemical product plus information. It is a very important task of the regulatory agency to ensure that drug information is unbiased, correct, updated and easily accessible to prescribers and consumers.
Review and approval of product data sheets and labels
The system of drug evaluation and registration includes the review and approval of the product data sheets and labels. This information is usually disseminated through drug inserts or drug formularies. There is increasing discussion of whether the information that the DRA uses to assess the efficacy and safety of new drugs for market approval should be made accessible to public scrutiny - even if the information is unpublished data which the company may consider as confidential. Many provincial and institutional drug committees would like to use this information for their own decisions on clinical guidelines and essential drugs lists.
Regulations to control drug promotion and to ensure the quality of information provided are important in promoting more rational use of medicines. National drug policies should therefore include provisions for regulating promotional activities. WHO’s Ethical criteria for medicinal drug promotion58 can serve as a basis for developing measures to control drug promotion. The guiding principles are that promotion should be in keeping with national health policies and in compliance with national regulations, as well as meeting voluntary standards where they exist. All promotion-making claims should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste.
Monitoring the quality of promotional activities needs adequate resources and a clear political commitment to enforce the relevant regulations. Possible sanctions include appropriate fines and published retractions of misleading claims in the media in which they were originally made.