Section 1: Requirements for Promotional Claims Directed at Healthcare Professionals

Companies are permitted to promote prescription products to healthcare professionals so long as all information, claims and graphical representations are current, accurate, balanced, consistent with the approved product information, and do not mislead directly, by implication, or by omission. This responsibility relates to any information given or claims made about the product being promoted, other products, disease states or conditions.^{1 2 3}

1. Companies are responsible for ensuring that all promotional claims are referenced and that cited reference/s provide the appropriate level of evidence for the claim being made, reflect the body of evidence, and allow healthcare professionals to independently evaluate the validity of the results and hence the claim.
2. If qualifying statements are used with a promotional claim, they should be linked to the relevant claim with a readily identifiable symbol and appear directly below or adjacent to the claim. Qualifying statements must be prominent.⁴
3. Companies are responsible for appropriately qualifying where claims are based on animal or laboratory data.
4. Any claims for clinical benefit need to be of a magnitude that is generally accepted as clinically meaningful and supported by the body of evidence.
5. The statistical significance of comparative claims must be clearly indicated.
6. Companies should consider the appropriateness of superlatives and ensure that, when used, the superlative is substantiated by the appropriate level of evidence.
7. Wherever a healthcare professional’s name, image or a direct quotation from their presentation or unpublished communication is used in any kind of promotional material, the Company should ensure that the healthcare professional provides documented approval.
8. ‘Hanging’ comparative claims should not be used. Examples of ‘hanging’ comparatives include those that merely claim a product is better, stronger, or more widely prescribed.
9. Companies are responsible for having systems in place to ensure all data to substantiate claims is easily retrievable so that they can be supplied on request within 10 working days.

---

1.1 Balance

1. Companies are responsible for ensuring they provide balanced information on products to support their appropriate use consistent with the Product Information (PI).
2. Balanced promotional materials provide proportionate weight to the benefits and risks of a product, and they recognise that product and risk information are as relevant as any therapeutic, promotional, or non-promotional claim.
3. The presentation of risks should be appropriate to the complexity of the promotional material, the therapy area, stage of product lifecycle and support the product’s appropriate use consistent with the PI.

1.2 Substantiating Data

1. Substantiating data should not consist solely of posters, abstracts, ‘personal communication’ or unpublished data, as these data do not provide sufficient information to assess the veracity of a claim. These data sources can be used as secondary references to support claims.
2. Substantiating data can consist of an ‘in press’ article or data on file where these references are available to be supplied on request and provide the appropriate level of evidence to support the claim. The use of ‘data on file’ may be appropriate as sole substantiation for a claim regarding prescribing frequency or cumulative patient exposure; however, it would not be appropriate as sole substantiation for a safety or an efficacy claim.
3. Substantiating data should be consistent with the body of evidence.
4. Selective use of consistent positive results while neglecting consistent negative results from a systematic review or meta-analysis is not appropriate.
5. Claims based on pre-specified secondary endpoints where the primary endpoints are not met in a particular study can be used if:
   1. consistent with the body of evidence; and
   2. they accurately reflect the conclusion of the study; and
   3. it is clear to a reader that the primary endpoint was not met.
6. It is only appropriate to extrapolate from surrogate endpoints where a link between the surrogate endpoint and the clinical outcome has been generally accepted and is supported by the body of evidence.
7. The use of post-hoc analyses is acceptable if clearly identified as post-hoc, used in context of the primary endpoint(s) and appropriately qualified. It should be made clear to the reader if the primary endpoint(s) of the original study was not met or if the claims based on post-hoc analyses are inconsistent with the primary endpoint(s).
8. Observational data may be used to substantiate a claim when the data is of high quality and represents the highest level of evidence available.
9. Animal or laboratory data are insufficient to be used as the sole evidence to support a promotional claim. If animal or laboratory data are used, a qualifying statement must appear identifying this type of data and acknowledging that such data do not necessarily predict clinical effects.
10. Claims based on statistical comparisons must include sufficient detail to enable the reader to understand the statistical significance of the data. The accepted level of statistical significance is p < 0.05 and for multiple comparisons will be lower, as specified in the study publication or published protocol when available.
11. If the results of a comparative study are not statistically significant, a qualifying statement must be included stating, in full, that the results are “not statistically significant”.
12. If the results of a comparative study do not include a statement of the significance or lack of significance of the results, a qualifying statement must be included stating that the p value is not available.
13. Comparative claims based on studies reporting clinically important differences must include sufficient detail to enable the reader to understand the significance of the data. The minimum clinically important difference, when available and defined for the trial, is the accepted level of clinical significance.

---

1. #50: How long do we have to correct content? ↩︎
2. #51: Using imagery in promotional material ↩︎
3. #71: Can we promote if the product is unavailable? ↩︎
4. #14: Rotating digital ads – one frame or more? ↩︎