TGA team earns US award

Two scientists from the TGA in Canberra have been presented with US Vice-President Al Gore's Hammer Award for their work on exposing counterfeit medicines. Dr Larry Kelly and Mr Robert Prestridge accepted the award on behalf of the TGA at a ceremony in Washington D.C. on 29 June.

Hammer Awards are presented in recognition of innovative work performed in the public interest. The hammer symbolises the breaking down of barriers though teamwork, and a collaborative effort to achieve significant advances. Among scientists from several other national agencies who were also recognised for their work in this field, Dr Kelly and Mr Prestridge are founding members of an international group which first met in 1997 in response to increasing concerns over the spread of counterfeit medicines, especially the active raw materials used to formulate medicinal products. The group also includes members from the US, the UK, Germany, Canada and the Netherlands.

The Hammer Award recognises the TGA's contribution to the development of an analytical method to detect counterfeit and sub-standard ingredients in medicines. The method utilises the characteristic profile or 'fingerprint' of an impurity residue arising from the manufacturing process, which, when compared with data from other regulatory agencies, allows its source to be verified.

The method can also be applied to herbal substances-herbal species can be characterised to enable the detection of substitution, adulteration and contamination in herbal medicinal products.

TGA Laboratories staff who assisted with development of the method include Jean Barrie, Bob Irvine, Vidya Jagadish, Adrian Krauss, Pam Larkin, Mali Maliyasenya, Tue-Hai Nguyen, Kirsten Sharp, Margaret Smith and Leonor Winter.

In congratulating Dr Kelly, Mr Prestridge and TGA Laboratories staff, Parliamentary Secretary for Health and Aged Care Senator Grant Tambling said: 'Governments worldwide agree that international trade in pharmaceuticals and herbal products from unapproved sources is an area of great concern. If undetected, counterfeit preparations pose a serious threat to the supply of safe and effective legitimate medicinal products. The issue of counterfeit medicinal products was considered recently by the Parliament when changes were made to Australia's legislation to strengthen regulatory controls and increase penalties for the manufacture, supply or export of counterfeit therapeutic goods.'

The new method has been made available to industry and to other regulatory agencies, and was briefly outlined in previous issues of TGA News. Recent editions of the TGA Laboratory Information Bulletin <http://www.tga.gov.au/docs/html/lib/libindex.htm> contain more details of the methodology.