Pharmaceutical companies seeking to win marketing approval for antidepressants should not be required to include long-term data on safety and efficacy in their initial marketing applications, according to a US Food and Drug Administration (FDA) advisory committee.
The panel voted 12-0 against requiring long-term data in dossiers, after hearing arguments from Industry representatives that the measure would only delay approval of new drugs – perhaps by as much as a year – and discourage development of new antidepressants. Most companies developing antidepressants rely on acute data for their initial marketing application and then generate long-term data in the post-marketing phase.
The FDA convened the meeting in the wake of safety problems that have emerged with the selective serotonin reuptake inhibitor (SSRI) class of antidepressant, particularly with regard to the risk of suicide in children and possibly adults [[29/09/05b]] [[31/05/05g]].
The European Medicines Agency (EMEA) already requires data on long-term efficacy, according to the FDA, but the panellists agreed that adding this requirement in the US market would make it harder for companies to bring new products to market, and would not impart any major benefit for patients.