Drug Evaluation Committee 2012-49 Posting of Therapeutic Effects of Investigational New Drugs in Advertisements for Recruitment of Human Subjects
Related classification：Recruitment of human subjects
Initial release date: Mar. 2013
Revised publication date: Mar 2021
Question
In the section "1. Recruitment of subjects conducted by medical institutions" on page 5 (reference) of "Guidelines for providing information for the recruitment of subjects for clinical trials - revised edition (November 2008)," the following statement is found.
Name of the investigational drug (including the investigational drug symbol)
According to the amendment of the Medical Care Act (2007), "Generic names (names of ingredients) or development codes may be advertised from the viewpoint of promoting the provision of information on clinical trials. However, in light of the fact that the Pharmaceutical Affairs Law prohibits advertisements of unapproved drugs, specific information on therapeutic effects, excluding the name of the disease that is the subject of the clinical trial, or the domestic or foreign trade name (product name), shall not be permitted, even for advertisements related to medical care." The name of the investigational drug (including the clinical trial symbol) may be described.
Please tell us the following points regarding this "matters relating to specific therapeutic effects excluding the name of the disease that is the subject of the clinical trial".
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(1)There is no problem with advertising the name of the disease that is the subject of the clinical trial, but any advertising of specific therapeutic effects is not allowed.
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(2)Advertisements regarding the therapeutic effect in the disease that is the subject of the clinical trial are acceptable, but advertisements of the effect in diseases that are not the subject of the clinical trial are not allowed. For example, is it prohibited to state that the investigational drug has such an effect on breast cancer, even though lung cancer is the target disease?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Given the purpose of the prohibition of advertisements of unapproved drugs under the Pharmaceutical Affairs Law, I think that although advertisements of what disease an investigational drug is being used for falls within the category of providing information on clinical trials, the expected effects of an investigational drug (e.g., its ability to lower blood pressure) are not allowed because they would fall under the category of advertisements of unapproved drugs. Therefore, we believe that (1) is appropriate.
Reason for revision of opinion
With the enforcement of the Pharmaceutical Affairs Act (November 25, 2014), minor changes were made to the description.