There are certainly more important problems, but as a general practitioner I was struck by the Aifa affair. Not so much from any wrongdoing, but from the fact that it is now discovered that the times taken for the approval of drugs are double those in Europe. It seems to me a scandalous slowness comparable to that of the judicial system. PF Milan Bureaucratic slowness and inefficiency, typical Italian evils, certainly weigh on the community. Perhaps also in terms of health when it comes to drugs: the AIFA of which our reader speaks, we remind you, is the agency that controls them and authorizes their placing on the market. The institution was recently affected by a legal case and is undergoing restructuring. In this regard, Undersecretary for Wellfare Ferruccio Fazio underlined that the agency "has worked well", but recalled that "the European Medicines Agency, EMEA, takes an average of 210 days for an authorisation, against 540 for AIFA". And the aim is therefore, in the reorganization, to speed up these times which appear decidedly long. Yet I'm not convinced that speed is necessarily a virtue in this case. When we think of the arrival of a new drug, we unconsciously think of the post-war patients waiting for the arrival of penicillin. In the vast majority of cases today this is not the case. We ourselves have on occasion welcomed the protests of patient associations requesting the approval of a new molecule (or a new indication thereof) deemed significantly better. But in general we think that drugs should not be rushed. Even in the United States (after some events related to the unexpected effects of some preparations that rapidly entered widespread use) the excessive rapidity of approval by the FDA has been questioned, evidently based on incomplete scientific documentation. And I am convinced that you too, as a family doctor, for common and non-serious pathologies prefer to turn to the good old medicine, whose effects and contraindications you know well, rather than the unknown newcomer. More than speed, we think control is important, before and after (pharmacovigilance) the placing on the market. And caution. Understanding that if a "new penicillin" ever arrives, exceptional procedures could always be adopted for rapid approval. Corriere della Sera of 06/07/2008, article by Riccardo Renzi ed. National HEALTH p. 54
