FDA Issues Two Proposed Studies on Disclosures for Advertising

Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for oncology advertising. Both studies have comment periods that end on August 18, 2017. For both proposals, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. General Advertising The Food and Drug Administration Office of Prescription Drug Promotion (OPDP) plans to investigate the way repetition and over warning apply to the presentation of risks in promotional prescription drug print pieces. They propose to test two levels of the Important Safety Information (ISI) – short versus long – and the presence of the Brief Summary in two different medical conditions (overactive bladder and rheumatoid arthritis). This will be investigated in DTC print ads for prescription drugs. OPDP will collect descriptive eye tracking data on adult participants' atten...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs