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UPDATE
Forum
Springer International Publishing Switzerland 2014
1 Risks, Benefits of Rx Drugs and Devices: US Issues Draft Guidance The US Food and Drug Administration (FDA) has issued a draft guidance related to presentation of risk and benefit information for FDA-regulated prescription drugs and medical devices on electronic/digital platforms that are associated with character space limitations (e.g., Twitter, paid/sponsored links on internet search engines). Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA has responsibility for regulating the manufacture, sale, and distribution of drugs and medical devices in the US, which includes oversight of the labelling of such products, and advertising of prescription drugs and restricted medical devices. When the FDA evaluates advertising and promotional labelling for compliance with the FD&C Act and its implementing regulations, the agency determines whether claims about both the benefits and risks of the product ‘‘are accurate and non-misleading’’, and that these ‘‘are presented in a comparably prominent manner’’. When communicating the benefit and risk information for prescription drugs and medical devices on internet/ social media platforms with character space limitations, the FDA states that the following points should be considered: •
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Benefit information should be accurate and nonmisleading, and reveal material facts within each individual character-space-limited communication (e.g., in individual message or tweet). Benefit information should be accompanied by risk information within each individual character-spacelimited communication.
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If a firm concludes that adequate benefit and risk information (as well as other required information) cannot all be communicated within the same characterspace-limited communication, then the firm should reconsider using that platform for the intended promotional message.
The FDA states that ‘‘regardless of the platform, truthful, accurate, non-misleading, and balanced product promotion best serves the public health’’. US Department of Health and Human Services, et al. Guidance for industry internet/social media platforms with character space limitations— presenting risk and benefit information for prescription drugs and medical devices [online]. 1 Jun 2014. Available from URL: http://www.fda.gov/ downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ ucm401087.pdf. Accessed 2014 Sept 25.
2 EMA Consults on Updated Access to EudraVigilance The European Medicines Agency (EMA) has launched a 6-week public consultation on its updated EudraVigilance access policy. The first EudraVigilance access policy, in 2011, defined levels of access to information on adverse drug reaction (ADR) reports in EudraVigilance for European regulators, healthcare professionals, consumers and patients, marketing authorisation holders, and research organisations. The proposed update maintains the principles of the original policy but takes into account changes to the system of safety monitoring of medicines introduc
