Tag: FDA study

FDA study

Regulatory/FDA

FDA Studying Extent of Risk Information in DTC Print Ads

FDA Studying Extent of Risk Information in DTC Print Ads

Aug. 20, 2018 – The FDA continues to consider whether the amount and location of risk disclosure information currently appearing in direct-to-consumer (DTC) print ads – both in the brief summary and the “important safety information” (ISI) section – has the potential to “overwarn” consumers. In an FDA notice in the Federal Register last week, […]

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Regulatory/FDA

FDA Finalizing Study of Disclosure Effectiveness in Drug Promotion

FDA Finalizing Study of Disclosure Effectiveness in Drug Promotion

Aug. 13, 2018 – The FDA released final details about the study it plans to conduct on the effectiveness of drug company disclosures in professional and consumer prescription drug promotion in an Aug. 9 Federal Register notice. Specifically, the aim of the research is to “examine the effectiveness of clear and conspicuous disclosures in prescription […]

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DTC Advertising

Limiting Risk Disclosures in DTC Ads Improves Recall of Risk, FDA Study Shows

Limiting Risk Disclosures in DTC Ads Improves Recall of Risk, FDA Study Shows

Aug. 11, 2017 – The results of a recent study conducted by the FDA and RTI International has concluded that a revised, briefer risk statement in broadcast direct-to-consumer (DTC) ads improves risk and benefit recognition and risk recall. As such, a move toward communicating a limited number of risks and including a disclosure alerting consumers […]

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Regulatory/FDA

FDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion

FDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion

Jan. 4, 2017 – The FDA will examine whether consumers and health care professionals (HCPs) can identify deceptive claims in prescription drug promotion, according to a notice published in today’s Federal Register. Results of the study could lead to an expansion of the FDA’s Bad Ad program to include consumer reporters. Although empirical research has […]

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FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed to address concerns the FDA has about this vulnerable population, the agency stated in a notice published July 21 in the Federal Register (2014-16998). “Adolescents are a unique audience for DTC drug marketing because their […]

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