PubMed · 12374075
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David Hawkins. 2002-10-01. Speaking for hire.. https://doi.org/10.1093/ajhp%2F59.19.1870
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Since the early 1900s, national and international drug control legislation has acted as a key site of contention between important societal actors. Physicians and pharmacists, regulators and drug companies, patients and addicts, and researchers and pharmacologists all attempted to influence formulation and interpretation of the rules that regulate access to addicting but medically useful substances. The 1970 Controlled Substances Act (CSA) consolidated and rationalized previous US domestic legislation and paid careful attention to the international aspects of the issue. Yet the CSA also incorporated long-standing fundamental disputes about who would act as gatekeepers, what criteria would be employed in regulatory decisions, and the basic goals of drug control legislation. Rather than view the CSA as a beginning or an end, it is better conceived as a major milepost in a century-long odyssey of maneuvering among interested parties for advantage in a complex regulatory environment. Instead of providing a definitive authoritative structure to which all parties must adhere, the CSA has served as a vehicle for discernment and continuous renegotiation of essential concepts such as "abuse liability".
This study was set up to document the variability of prescribing information from different sources concerning indications, side effects and cautions of selected drugs. An original method to measure the degree of information agreement among different written materials, such as summaries of product characteristics, package inserts and data sheets, and a widely accepted reference text was developed. The results show that there is substantial disagreement in the materials available to prescribers and patients in different countries. Disagreement was even found within a single country when written materials from different brands of the same drug were compared. The discordance can be explained by the fact that the evidence available for each drug is considered/assessed differently by separate countries. It is argued that the discrepancies found may mislead prescribers, patients and those comparing drug-use patterns across countries. National regulatory authorities have a key role to play in remedying this situation, and a two-pronged approach is proposed. At the international level, national authorities should strengthen collaboration and information interchange and, at the national level, should implement appropriate measures aimed at removing contradictory statements on drug-information materials that have no reason to be different. Finally, further training and continued education aimed at drug regulatory officials could provide the necessary knowledge and enable national authorities to meet the need for drug information that is independent of commercial interests.