Empirical Study of Promotional Implications of Proprietary Prescription Drug Names

ICR 202103-0910-011

OMB: 0910-0896

Federal Form Document

Forms and Documents
ICR Details
202103-0910-011
Received in OIRA
HHS/FDA CDER
Empirical Study of Promotional Implications of Proprietary Prescription Drug Names
New collection (Request for a new OMB Control Number)   No
Regular 03/22/2021
  Requested Previously Approved
36 Months From Approved
3,452 0
524 0
0 0

As part of its premarket review, the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research’s (CDER’s) Office of Prescription Drug Promotion (ODPD) evaluates proposed proprietary drug names for safety and promotional implications. The primary purpose of the main study will be to examine: (1) whether names that reference the drug’s indication affect consumers’ and health care providers’ perceptions and (2) whether names that overstate the efficacy of the drug affect consumers’ and health care providers’ perceptions of prescription drugs. To address these goals, FDA will conduct an experimental study with consumers and health care providers using “target,” “neutral” (control), and “extreme” drug names indicated for either high cholesterol or gastroesophageal reflux disease (GERD). The main study sample will include 448 primary care providers (PCPs) and 448 members of the general population. We will use a within-subjects design for the main study to increase efficiency and keep the sample size small. Participants will view names for two medical indications in random order (one list for high cholesterol and one list for GERD). The main study will include a total of 14 drug names, 7 for each of two medical conditions (one extreme name, one neutral name, and five target names). The survey will not exceed 20 minutes. Survey items will include benefit perception items and attitude and intention items.

None
None

Not associated with rulemaking

  85 FR 3392 01/21/2020
86 FR 14440 03/16/2021
Yes

4
IC Title Form No. Form Name
Consumer Screener
Consumer Study
Healthcare Providers Screener
Healthcare Study

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 3,452 0 0 3,452 0 0
Annual Time Burden (Hours) 524 0 0 524 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$469,684
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/22/2021


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