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EMA publishes European drug shortage details

First public list contains details on Cerezyme, Fabrazyme, Increlex and Vistide

The European Medicines Agency (EMA) has posted online a public list of all medicine shortages assessed by the agency as part of plans to help the region deal with drug supply issues.

The list provides both patients and healthcare professionals in the EU with access to information about each medicine shortage and what they can do to gain access to the affected product.

Details include information on the reason for the shortage and the current status of supply.

Drugs featured in the first version of the shortages catalogue include Sanofi/Genzyme's Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta), which are approved respectively for the rare diseases Gaucher disease and Fabry disease.

Information about the drugs featured by the EMA includes the update that stock levels are now at a level where patients can receive a full dose of either drug as well as recommendations that affected patients to get in touch with the rare disease organisation Eurordis.

The two other drugs with shortages assessed by the EMA are Ipsen's Increlex (mecasermin), for people with a growth disorder due to severe primary insulin-like growth factor-1 deficiency, and Gilead Sciences' Vistide (cidofovir), which treats a viral infection of the retina.

The launch of the catalogue is one feature of a plan developed by the EMA in 2012 to provide guidance on dealing with shortages caused by manufacturing problems.

The plan is built on lessons learned during recent drug shortages, such as those caused by manufacturing problems at the Ben Venue manufacturing plant in the US, and aims to provide both short- and medium-term plans to both prevent and manage medicines shortages on a pan-European level.

Other activities carried out by the EMA include a workshop held in October that saw stakeholders discuss ways to prevent medicine shortages due to manufacturing and quality problems.

Regulators in the US are also looking to address problems of drug shortages after 251 cases were reported in 2011.

The Food and Drug Administration (FDA) announced last week a new plan to improve its response to shortages as well as new rules that mean drug manufactures will have to provide early notice of any potential interruption to supply.

Article by
Thomas Meek

5th November 2013

From: Sales, Regulatory, Healthcare



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