Global Insight Perspective | |
Significance | AIFA has withdrawn marketing approval status for 11 as-yet-unnamed generic drugs, after discrepancies were found in their bioequivalence test results. |
Implications | The product recalls are the result of a six-month investigation, which culminated in AIFA demanding that all firms with generics already on the market or in the approval process re-submit their registration and bioequivalence data. |
Outlook | With generics consumption in Italy already the lowest in the European Union, AIFA's heavily publicised withdrawal of 11 generic drugs will damage the reputation of a sector that is struggling to gain the confidence of Italian doctors and patients alike. |
The Italian Medicines Agency (AIFA) has withdrawn the marketing approval of some 11 generic drugs, following a six-month investigation by magistrates in the northern city of Turin. The agency has refused to name the drugs in question, but said that the investigation uncovered several irregularities in their marketing applications, namely, the falsification of bioequivalence test results. In Italy and elsewhere, generics companies are expected to demonstrate that their product submitted for approval is bioequivalent to the original brand-name version, allowing a prescription for one drug to be substituted for another if necessary.
As the six-month investigation neared its conclusion, AIFA took the step of demanding that all companies with generic drugs either already on the market or in the marketing approval process re-submit their registration details, including detailed bioequivalence reports, stating in which country and laboratory the tests had been carried out. According to APM Health Europe, companies were given a deadline to meet the request and supply the information by 10 September, although it is not clear how many were able to comply.
Meanwhile, AIFA itself continues to face accusations of not doing enough to facilitate the promotion of new generics, with the Corriere della Sera newspaper suggesting that the Turin magistrates’ investigation into generic bioequivalence tests could be linked to a wider investigation of AIFA’s drug approval times. AIFA has rebutted the accusations that it takes too long to approve generic drugs by stating that it takes an average of 90 days for generics to be granted marketing approval.
Outlook and Implications
While AIFA has attempted to play down the importance of the drug withdrawals scandal by saying they represent “11 products out of more than 2,300 on the market”, there is already concern that the scandal will hurt the Italian generics industry. According to Corriere della Sera, the head of the Assogenerici generics industry association has said that “The uncertainty is producing irreparable damage to the sector.” While generic substitution is encouraged at the pharmacy level, the take-up of generics in Italy remains the lowest in Europe, with generics representing just 2.05% of the pharmaceutical market in value terms and 4% in volume terms in 2004, according to the European Generic Medicines Association. Global Insight believes that popular acceptance of generics will increase as bioequivalent generics gain more prominence on the market than the traditionally dominant, branded non-bioequivalent copies of original drugs. However, a perceived trend of generics manufacturers deliberately falsifying their bioequivalence data will go some way towards destroying the confidence built up in the sector, particular by doctors, who have long been opposed to generic substitution on the grounds that it undermines their prescribing authority.