Bayer has overturned a ruling that it brought discredit on the pharma industry. Accused of “warming the market” for a new Eylea indication, the German drugmaker successfully argued on appeal that an advisory board was in fact legitimate.
An anonymous complainant sparked an investigation by U.K. self-regulatory body PMCPA after claiming that Bayer disguised pre-license promotion of Eylea as an advisory board meeting. The complainant called out Bayer for allegedly holding two similar meetings within three months, not sending any pre-work, paying some participants more than fair market value and otherwise making improper arrangements.
Bayer refuted all the allegations, arguing that its advisory board was legitimate, necessary and compliant with the U.K. drug marketing code.
The PMCPA initially sided with the complainant and ruled that Bayer had breached six clauses of the code by promoting Eylea and its then-unapproved higher dose at the meeting.
“The Panel considered that the cumulative effect of Bayer’s actions meant that it had made payments to eight health professionals to attend a promotional meeting,” the PMCPA wrote in its initial ruling. “The content of which related to a product which, at the time, did not have marketing authorization. Bayer had therefore failed to maintain high standards.”
Bayer appealed all the breaches in the PMCPA ruling, framing its appeal around the nine conditions of a legitimate advisory meeting set out by the regulatory body. Bayer said it needed expert input on high-dose Eylea to inform the launch, particularly at a time when the market was evolving quickly, as Lucentis biosimilars and Roche’s competing Vabysmo launched around the time of the meeting.
The drugmaker cited prior PMCPA rulings to argue the meeting met other criteria for a legitimate event. For example, the self-regulatory body questioned in its initial ruling whether the 1:2 ratio of staff to advisors at the Bayer meeting was acceptable, but the company pointed out that an earlier PMCPA investigation into an advisory board meeting run by AstraZeneca and Merck & Co. used a 1:2 ratio as the threshold of acceptability.
Similarly, Bayer quoted a PMCPA investigation into Britannia to make the case that its ratio of discussion time to presentation time was acceptable. Bayer said discussion took up 78% of the meeting, and the PMCPA panel said the 78:22 split between discussion and presentation was “on the outer limits of acceptability.” Yet, Bayer noted the panel in the Britannia case only queried whether a 70:30 split was sufficient.
Bayer’s extensive response convinced the PMCPA appeal board, which said the concept document was clear and robust, the minutes were very detailed and highlighted a high level of discussion, and the invitation and contract clearly stated the purpose of the meeting was a Bayer advisory board. The board said it was acceptable to meet to help shape commercial, logistical and practical launch considerations for the new version of Eylea and therefore overturned all the previously levied breaches.