BioMarin Europe replies
Adrian Quartel, James Lennertz · BMJ · 2010
Among the inaccuracies in the open letter of Nicholl and colleagues,1 is the statement that the chemical 3,4-diaminopyridine base (3,4-DAP) has an excellent safety record. This cannot be substantiated by evidence since 3,4-DAP has not undergone systematic safety and toxicology testing nor does it have appropriate safety monitoring and pharmacovigilance systems in place to capture, analyse, and report such data. 3,4-DAP is not a generic drug but …