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The TGA and the USA FDA agree about problems at CSL Biotherapies

Behind the news

8 July 2011

This TGA behind-the-news article was published on 8 July 2011. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

On 15 June 2011, the United States of America's Food and Drug Administration (FDA) issued CSL Biotherapies Ltd a 'Warning Letter' setting out deficiencies that it identified during its audit of March 2011. This letter advised the company that they should address the deficiencies and that failure to respond within 15 days 'may result in regulatory action without further notice' and that '...such actions may include license suspension and/or revocation'. FDA and TGA have worked together closely in evaluating CSL's issues and continue to work together with the company as it addresses ways to come into compliance.

The TGA wishes to clarify some aspects of this action and what it means for public safety. The TGA consulted with the FDA on the drafting of this statement to ensure it accurately reflects their views. The two regulators are in agreement over the problems identified at CSL, any potential risk to the Australian and American public and the future management of that risk.

The FDA inspection program of Australian manufacturing facilities for the purposes of assessing compliance with US regulations is a co-operative effort with the TGA, and takes into account TGA's expertise, local knowledge and close proximity to manufacturing facilities in Australia.

Similarly, while the TGA conducts its own audits of American manufacturers, it integrates the outcomes of the FDA audit program of its domestic sites as part of its overall compliance program to ensure the safety and efficacy of therapeutic goods imported into Australia.

Both agencies work closely together and advise each other of regulatory activities taking place within each other's jurisdiction. The global nature of the manufacturing process for pharmaceuticals and medical devices means that, increasingly, regulatory agencies around the world are working more co-operatively together.

The warning letter sets out that the FDA identified during its audit in March 2011 that CSL's investigation processes into post-manufacturing deviations and adverse events were not satisfactory. The letter references, by way of example, the company's investigation into the adverse febrile reactions that occurred in children in April 2010. The deficiencies identified by both regulators include the fact that CSL does not thoroughly investigate problems that are detected. The audits have identified other examples of this problem.

While both the TGA and the FDA are of the view that, based on the information currently available, the deficiencies don't represent a risk to public health, they are of a nature that, if left unaddressed, could have future public safety implications. Therefore, it is important that CSL actively works to rectify all the concerns raised adequately. In the meantime, the TGA is closely monitoring the situation to ensure that neither Australian nor American consumers of CSL products are exposed to unnecessary risk.

The TGA has conducted scientific studies and innovative analyses to better understand febrile reactions to influenza vaccines, to explain why the rate of febrile reactions was higher than expected during the 2010 flu season.

In conducting its investigations, the TGA has worked closely with the FDA and other US agencies, with laboratories in the FDA and the Centers for Disease Control and Prevention undertaking testing and analysis on behalf of the TGA. To date, no underlying cause for the adverse reactions has been identified. Work is ongoing.

Full details of the TGA's investigations can be found at Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children.

In the meantime, the TGA has not approved CSL's Fluvax product to be used in children under 5 for the 2011 influenza season.