US FDA’s ‘Incremental Step’ On Rx Ads: A Long Time Coming
Final rule on the so-called ‘major statement’ in direct-to-consumer broadcast ads comes 15 years after the law it is implementing. A lot has changed in the advertising world since then – but FDA says the principles of ‘clear, conspicuous and neutral’ presentation of risk information still apply.
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FDA’s final rule on the major statement in DTC ads includes additional standard for presenting a drug’s side effects and contraindications in a clear, conspicuous and neutral manner. Rule permits ‘creative elements’ during presentation, including upbeat music.
An updated US FDA policy governing dissemination of ‘off-label’ journal reprints and other scientific communications suggests the agency feels on firmer legal ground to reaffirm some guardrails. It also expands the regulatory vocabulary to include ‘scientific information on unapproved uses,’ or SIUU.
The US Food & Drug Administration is once again proposing a mandatory summary of key labeling information be dispensed with every prescription drug. Will the idea stay on the books this time?