Regulators at the US Food and Drug Administration (FDA) are planning to conduct a study on consumers' understanding of composite endpoint scores used in direct-to-consumer (DTC) advertising. Composite scores are essentially a collection of clinical endpoints combined into a single overall score. An allergy drug might, explains FDA, use a composite score that measures a patient's runny nose, congestion, nasal itchiness and sneezing. Do Consumers Understand What a Compo...

How long does it take for the US Food and Drug Administration (FDA) to get a study up and running? For at least one previously-proposed study on promotional advertising, nearly two years. Since September 2010, FDA has been looking to conduct a study on consumers to assess the effects of promotional offers in direct-to-consumer prescription drug print advertising. In its 22 September 2010 Federal Register posting , FDA proposed the study as a way to look at how coupons...

The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech. FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, " New FDA Draft Guidance on DTC Television Advert...

The US Food and Drug Administration (FDA) announced this week it is reopening a comment period on a proposed rule on presenting major statements in director-to-consumer (DTC) advertisements, extending comments for an additional 15 days. The 23 March Federal Register notice follows an initial posting on 27 January, entitled Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescriptio...

The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public. Guidance for Industry - Direct-to-Consumer Television Advertisements - FDAAA DTC Television Ad Pre-Dissemination Review Program "describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under...

The US Food and Drug Administration (FDA) is calling for a study on corrective direct-to-consumer (DTC) advertising and its impact on correcting misperceptions about a product's safety and efficacy for a given indication. "FDA regulations require prescription drug advertisements to contain accurate information about the benefits and risks of the drug advertised.  When this is not the case, corrective advertising is designed to dissipate or correct erroneous belief...

The US Food and Drug Administration (FDA) released the results of a new study on 27 January that explores the impact of distraction on a consumer's understanding of important information in direct-to-consumer (DTC) television advertising. The study , Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements , was conducted in response to a proposed...