DDMAC calls Ipsen white paper misleading, serves warning letter

Although no product was explicitly mentioned, DDMAC found plenty to dislike about a white paper and other unbranded materials circulated by Tercica, a subsidiary of the Ipsen Group.

The Warning Letter, DDMAC’s most severe form of epistle, was posted on the FDA’s website last week, and took issue with a letter signed by Ron Rosenfeld M.D., a white paper discussing “insulin-like growth factor deficiency,” and a set of assessment tools. “While not using the established name of the Ipsen/Tercica drug – Increlex – the letter, white paper and assessment tools effectively promote this drug product,” the Warning Letter said.

Where established brand promotion exists, so must risk information and the correct drug indication. The Ipsen white paper presents various efficacy claims for IGF-1 therapy (“i.e., Increlex,” the Warning Letter notes), but entirely omits risk information. “Your total omission of risk information is extremely concerning from a public health perspective,” the Warning Letter said.

The white paper also broadens the indication for Increlex, and fails to provide adequate directions for use, according to the Warning Letter, written by DDMAC director Tom Abrams. As a result, Ipsen must submit to DDMAC a plan of action to disseminate corrective messages to all audiences that received the violative materials.

DDMAC has made it clear that the absence of a brand name does not protect materials it deems violative. GlaxoSmithKline received an Untitled Letter in April over an unbranded disease awareness ad that DDDMAC called a promotional piece for Arzerra. Novartis also received a Warning Letter in April, which said brand messages for Gleevec were implied on two websites that didn’t mention the drug by name.

Arnold Friede, a former attorney for Pfizer and principal at Arnold I. Friede & Associates, said the Warning Letter was in keeping with DDMAC’s position on implied or suggested brand content. “Companies need to be very cautious” with respect to the line between educational materials and brand promotion, said Friede.