Icepharma‘s comments regarding recall of brochure from Merck Sharp & Dohme demanded by the IMA
The IMA has requested a recall of a brochure from MSD “Take Action – Control your Diabetes”. With regards to that Icepharma wants to address that the brochure in question was considered to be fully in line with the Medicines Act no. 93/1994 which states in article 16 that marketing authorization holders or their representatives are allowed to distribute general information on diseases and the use of certain medication to patients.
The brochure is a translation of the same brochure from Denmark. No comments have been received regarding its use in Denmark. The brochure refers to clinical guidelines from DSAM (Dansk Selskab for Almen Medicin) that have HbA1c at 6,1% as its most detailed goal. When the brochure was made and printed in Iceland – new clinical guidelines from the Directorate of Health had not been published. The clinical guidelines from the Directorate of Health do not recommend HbA1c below 6,5%.
The IMA received a complaint for the above mentioned brochure on November 20th 2009. Two months later or on January 15th Icepharma received a letter from the IMA about the complaint and Icepharma immediately cancelled further distribution. Following further communication with the IMA the agency requested a recall of the brochure which has now been done, as it is Icepharma’s goal to comply fully with the Icelandic Medicines Act.