The editorial in the latest edition of Australian Prescriber provides a balanced analysis of the fast-tracking of drug approvals. There are benefits for allowing early access to new therapies and treatments but what are the risks?
Dr Paul Kubler, from Royal Brisbane and Women’s Hospital, examines how the pressure to access innovative treatments is high, particularly for those suffering rare cancers and conditions with few treatment options, such as cystic fibrosis. He cautions, however, that regulators must still ensure the safety and efficacy of medicines.
Summarising the changing landscape of drug approval frameworks in Europe, the United States and Australia, Dr Kubler unpacks advocates’ reasons for supporting swift access to novel therapies and considers critics’ concerns that patients will be put at risk if approvals are based on the preliminary results of clinical trials.
Australian Prescriber is an independent peer-reviewed journal providing critical commentary on therapeutic topics for health professionals. It is published by NPS MedicineWise, an independent, not-for-profit organisation for quality use of medicines funded by the Australian Government Department of Health. Australian Prescriber is published every two months and is available online at nps.org.au/australianprescriber