FDA joins forces with pharma companies to target safety issues

The Critical Path Institute (C-Path), the US Food and Drug Administration's (FDA) initiative for the identification and prioritisation of medical product development problems, has joined forces with eight pharmaceutical companies to form the "Predictive Safety Testing Consortium".

The Consortium will share information on internally developed predictive safety tests for new treatments before they are tested in humans, the aim being to allow pharmaceutical companies to determine which of the lab tests that they have developed individually should be recommended by the FDA to screen drugs before they enter clinical testing in humans. Currently, these tests, when used only by individual companies, are of limited value to the FDA because the methods used have not been validated by an independent party.

Those companies involved will also test other companies" methods and refer their results to C-Path for submission to the FDA. The methods that the FDA finds reliable and reproducible will form the basis for agency-issued guidelines about which safety tests should be used in drug development.

The eight companies involved are: Bristol-Myers Squibb; GlaxoSmithKline; Johnson & Johnson; Merck & Co; Novartis; Pfizer; Roche Palo Alto and the Schering Plough Research Institute.

The FDA, while not a member of the Consortium, will assist it in an advisory capacity. "This unprecedented sharing of potential early indicators of clinical safety may streamline the cost and time of pre-clinical drug safety evaluation and better inform the use of personalised medicine.," reads an FDA statement.

The initiative is part of the Critical Path Opportunities List, which comprises 76 initial research priorities that, if accomplished, C-Path and the FDA believes will modernise the drug development process and help get new medical discoveries to Americans faster and at a lower cost by 2010.