IMS Health enlisted as information provider for drug shortages

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IMS Health enlisted as information provider for drug shortages

Home/Pharma News | Posted 18/05/2012 0 Post your comment

The Generic Pharmaceutical Association (GPhA) announced on 19 April 2012 that it had selected IMS Health (IMS) to serve as the Independent Third Party in the Accelerated Recovery Initiative (ARI), providing information on generic drug shortages to FDA.

‘As an established industry leader with decades of experience, IMS is ideally suited to fill this critical role,’ said Mr Ralph G Neas, President and CEO of GPhA. ‘IMS commands the respect of all stakeholders and has a reputation for confidentiality. Their unique ability to collect, process and communicate the complex manufacturing data the ARI requires will be essential to the initiative’s success, and will strengthen the entire healthcare industry’s collective ability to increase communication and supply patients with the medicines they need.’

The ARI, which was announced by GPhA in December 2011, is a voluntary initiative by the generics industry, which is designed to speed up the resolution of drug shortages for certain critical drugs, and is part of GPhA’s effort to ensure patients have access to safe, effective and affordable life-saving generic medicines.

The ARI is expected to complement the proposed Generic Drug User Fee Act, which will provide FDA with US$1.5 billion in additional resources and reduce the average time to review generics by nearly two years [1].

The ARI is based on voluntary communication between IMS and manufacturers and distributors of critical generics currently experiencing shortages. It is designed to use real-time supply and distribution information to give FDA a better understanding of current conditions, expand supply of critical drugs, and avert future shortages.

The type of information gathered and disseminated via the ARI will increase early visibility and communication between FDA and the generics industry about current and potential drug shortages. GPhA has been working closely with FDA, Federal Trade Commission, United States Department of Health and Human Services and Congressional Republicans and Democrats on this initiative.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Generic and biosimilar user fee recommendations sent to Congress [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 11]. Available from: www.gabionline.net/Generics/News/Generic-and-biosimilar-user-fee-recommendations-sent-to-Congress

Source: GPhA