WFH Statements and Advisories

WFH Statements and Advisories are notices published by the WFH that relate to issues on the safety, supply and access to treatment around the world. These notices include policy positions of the WFH, endorsements of position statements from other organizations, general health announcements of interest to our community and advisories related to the safety, supply and access to treatement for people with hemophilia and other bleeding disorders.

Disclaimer

These statements and advisories are provided for general information purposes only. The WFH does not engage in the practice of medicine and does not give medical advice. Under no circumstances does the WFH recommend particular treatment for specific individuals. For medical diagnosis or treatment, the WFH recommends that individuals consult their physician or local hemophilia treatment centre.

Latest WFH Statements and Advisories

WFH releases statement on orphan medicine status for hemophilia treatment products
July 2012 – The WFH has communicated to the US Food and Drug Administration and the European Medicines Agency its position on orphan medicine status for hemophilia treatment products. The WFH recommends that orphan drug designation should not be used to hinder, for the same condition or indication, the development, licensing and marketing of other products that are demonstrably different. WFH Statement


The World Federation of Hemophilia Product Selection Statement
February 2012 The WFH BPSSA and Executive Committee revised and updated this statement in February 2012. It is intended for Ministries of Health and regulatory agencies involved in the selection of treatment products for bleeding disorders. WFH Statement


WFH Statement on Expiry Dates
March 2003 – The World Federation of Hemophilia is an international not-for-profit organization. The WFH is not a regulatory agency and cannot make recommendations relating to specific clotting factor products. Each country’s regulatory authority must make these judgments based on domestic legislation, national health policies and clinical best practices.

The following information may assist regulators in making determinations with regard to clotting factor concentrates and expiry dates. An expiry date on a clotting factor concentrate is a guarantee of potency if stored according to manufacturer’s instructions. After the expiry date, although the manufacturer can no longer guarantee potency, the WFH is not aware of any safety problems with clotting factor concentrates. Clinical experience reported to the WFH suggests that, under appropriate storage conditions, the loss in potency immediately after the expiry date is negligible. Any loss in potency is gradual over months and factor concentrates may still be used safely and effectively in many clinical situations after their labeled expiry date. In critical situations, like life threatening bleeds or major surgery, use of these products should be accompanied by close clinical monitoring and appropriate laboratory assays.

Approved by WFH Executive Committee March 15, 2003