Pharmaceutical Regulatory Requirements for Marketing Claims

Highlights of Select Consulting Projects

<< Back to Project Summaries

 

Project ThumbRegulatory Requirements for Marketing Claims
Clients:
Top 10 Multinational Pharmaceutical Manufacturer
Description:

As a point of competitive differentiation, our client sought to include quality-of-life improvements as a component of their marketing program. To do this, it was necessary to provide sufficient evidence for inclusion of these claims on the product prescribing label.

VOI identified FDA and EMEA policies for inclusion of quality-of-life marketing claims, analyzed violation notices and promotional materials to determine triggers of regulatory sanctions and recommended clinical trial design and endpoints to ensure approval of marketing claims.

Separately, the same client wanted to include superiority claims against an existing product as part of their marketing effort. To do this, it was necessary to provide sufficient evidence for inclusion of these claims on the product prescribing label.

VOI identified FDA and EMA policies for inclusion of comparative claims, analyzed violation notices and promotional materials to determine triggers of regulatory sanctions and recommended clinical trial design and endpoints to ensure approval of marketing claims.

Results:

Our client incorporated our recommendations into the design of their late-stage clinical trials and was successful in obtaining regulatory approval for the necessary product labeling.

Categories:

Pharmaceutical marketing, FDA regulations, EMA regulations, FDA Office of Prescription Drug Promotion, drug labeling.

<< Back to Project Summaries

Related Products