Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–3792,
In FR Doc. 2010–30385, appearing on page 75480, in the
On page 75480, in the third column, the last sentence in the sixth complete paragraph states that no comments were received on the paperwork burden for the 60-day notice that published in the
Another question from this comment was the presentation of our manipulations. To clarify, the specific format of the presentation will be text only. We are investigating the use of charts and other visuals in another study (FDA–2009–N–0263 (January 5, 2010), “Presentation of Quantitative Effectiveness and Risk Information to Consumers in Direct-to-Consumer (DTC) Broadcast and Print Advertisements for Prescription Drugs,” OMB control number 0910–0663.) Because all of the respondents in the current study will see the information in the same format, this will not compromise our ability to answer the current research questions.
The comment also recommends expanding the physician study to include all health care professionals who have the ability to prescribe (
Finally, the comment recommends that FDA publish findings from the preliminary study related to the current project, “Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness” (FDA–2008–N–0589; April 3, 2009). We agree
Second, this comment recommends that we show physicians final magazine ads rather than conceptual ads. We agree and, as discussed in the response to the previous comment, we have contracted with an organization that produces professional-quality ads.
Third, this comment recommends increasing the sample size from 500 to 800 individuals. We agree that a larger sample would be desirable, however, given resource constraints we are not able to increase the sample size. Moreover, we have conducted a power analysis and have determined that our current sample size is adequate to answer our research questions.
Fourth, the comment recommends the removal of statements in the questionnaire that the drug is fictitious and instead label it a “potentially new drug.” FDA had many internal discussions regarding this issue and decided that because of the particular sample, it is necessary to be upfront with them about the nature of the drug. Physicians will be more savvy about the particulars of the chemical entities and the realism of the clinical benefits and we do not wish to make them skeptical of our purposes. We agree that this approach is preferable for consumers and so we will inform them that this is a potentially new drug in that part of the study.
Fifth, we agree that the characteristics of participants who are at risk and those who are or are not treating with a prescription drug may differ and we will include these variables in our analyses.
Sixth, the comment recommends altering question 17 of the questionnaire to reflect the physicians' use of the DTC ad versus their guess as to the understandability of the ad for patients. We agree that we are asking physicians to estimate the level of understanding their patients have. These perceptions are of specific interest to us as they relate to physicians' perceptions of DTC advertising and of the presentation of information in the ads. Physicians who have been in practice for any length of time may have a sense of how their patients will understand materials. This is a question that we will also investigate in relation to the number of years physicians have been in practice.
Seventh, the comment recommends that question 30 be split into two questions to separately assess the effect of DTC advertising on patients and the effect of DTC advertising on their practice. We agree and will make that change.
This comment also had two suggestions for the consumer part of the study. First, the comment recommended against delivering this study on a handheld device, as the viewing of the ad may render the concept unclear. We agree and have struggled with this issue, but due to the constraints of the internet panel, we cannot specify the type of device on which participants must take the survey. We have included a question to assess this variable, and we will analyze it to determine if there are sizable differences based on viewing medium.
Second, the comment recommends that the questionnaire avoid medical terminology and reference to the “prescribing information.” We have attempted to make the questionnaire clear for consumers and do not see the word “prescribing information” in the questionnaire. The questionnaire provided for comment includes programming notes that the respondent will not see.
Second, the comment recommends the introduction of a control arm that is similar to what is currently being used in the marketplace. Our design includes control conditions that do not present placebo information. These ads will look identical to the ads for products that are currently on the market.
Third, the comment questions the use of comparative benefit and comparative safety questions. We are using these measures for reliability as another way to assess consumers' perceived risk and benefits. As recommended in the comment, we are using them for informational purposes only and not as a specific, separate measure of comparative advertising.
Fourth, the comment recognizes the complexity of the data that are available to be conveyed in DTC ads. We agree that there are a number of questions to be answered that cannot be addressed in the current study:
Fifth, the comment recommends wording changes to the question about taking the drug if the doctor prescribed it. Although we understand the rationale for changing this question, it is a measure of behavioral intention and as such, we wanted to have a more blunt measure of intention. It will not be used to assess doctor-patient interaction issues.
Sixth, the comment questions the inclusion of physicians in the study, citing concerns that consumer responses