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# Comments on OPDP ‘Endorser Status’ Research
- URL: https://www.fdaweb.com/comments-on-opdp-endorser-status-research/
- Published: 2020-04-01T12:00:00.000Z
- Updated: 2026-09-14T16:09:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146475

The research proposed by CDER’s Office of Prescription Drug Promotion into celebrity endorser status and explicitness of payment in a direct-to-consumer promotion will likely reflect the opinions of a younger, female-skewed population, according to Duke University’s SciReg Lab in a 3/30 comment letter. The [letter](https://www.regulations.gov/document?D=FDA-2019-N-5900-0011&ref=fdaweb.com) says that if the overall goal is to gather information on young female populations who may or may not be familiar with acne or endometriosis, then the proposed study design is sufficient.

But if the goal is to collect data that can be applied to broader populations of prescription drug users, the comment says, the study should be modified to better reflect those users. The Duke researchers suggest that **(1)** the drugs used in the studies be representative of commonly advertised prescription drugs; **(2)** the drugs used in the studies should have target populations that are representative of the general population of prescription drug users; **(3)** the participants recruited for the studies should be representative of the target population of the fictitious drugs used in the studies, and **(4)** the participants recruited for the studies should be familiar with the conditions proposed in the studies.

In its [comment](https://www.regulations.gov/document?D=FDA-2019-N-5900-0011&ref=fdaweb.com), Pharmaceutical Research and Manufacturers of America says the proposed research will lack practical utility because **(1)** the proposed research, at least in part, duplicates information otherwise reasonably accessible to FDA; **(2)** unless substantially amended, the proposed studies will yield unreliable results with no practical utility because the proposed study design appears insufficiently rigorous; **(3)** the proposed research is unnecessary to the proper performance of FDA’s functions since the Federal Trade Commission takes the lead on regulating endorsement; and **(4)** the research is unduly focused on, and may be skewed by, the influence of a particular celebrity.