Amgen successful in Stage Three Appeal before PAAB

July 18, 2017

Torys represented Amgen with a team that included Teresa Reguly and Sumeet Dang (regulatory), Andrew Bernstein and Emily Sherkey (litigation).

On July 18, 2017, the Pharmaceutical Advertising Advisory Board (PAAB) released its decision in Amgen v. Merck Brenzys, the first Stage 3 hearing heard by PAAB in over a decade. The decision supported Amgen’s claim, confirming that an editorial discussing a biosimilar that was produced by Merck and which appeared in Biotechnology Focus, a life sciences industry publication, did not comply with the Food and Drug Act and Regulations, nor with Health Canada’s policies on advertising.

In the hearing, the PAAB Appeal Panel was asked to consider if the Biotechnology Focus editorial constitutes "paid advertising directed at Healthcare Professionals" and if it does, does the piece meet the requirements under the PAAB Code?

After hearing arguments from Merck, Amgen and PAAB, and sensitive to the precedents that would be set in making a decision, the Commissioner of PAAB determined that the journal piece was an Advertising Promotional System (APS) directed towards Healthcare Professionals and paid for directly and indirectly by Merck—and ultimately, that Merck’s APS required PAAB approval before it was used. Direct payments for the editorial included the ads placed by Merck in the journal and indirect payment involved the emerging relationship that was developing between the company and Biotechnology Focus.

This decision has implications for PAAB, life sciences companies and the media. The Appeal Panel addresses many of these implications in recommendations that accompany its decision; e.g., the Appeal Panel recommends a number of specific changes to existing advertising policies in the PAAB Code.

Amgen is a leading biotechnology company, committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics..

Further information can be found on PAAB’s website.

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