World's biggest drug recall "was illegal;" regulators in Australia and

7 September 2008

Australia's Therapeutic Goods Administration is facing a number of problems following its role in the collapse of complimentary medicine manufacturer Pan Pharmaceuticals in 2003. in the settlement of a law suit against the agency by the firm's founder, Jim Selim, in late August, the government has agreed to pay A$55.0 million ($46.7 million) in compensation and legal costs. According to local media reports, the TGA ordered the largest recall of its kind in the world, with 1,600 products affected, after problems related to Travacalm, a travel sickness drug which was the subject of adverse events including hallucinations, vomiting and hospitalizations.

However, evidence emerged that the decision to revoke the manufacturing license for all Pan products, without any complaints having been received or testing carried out, may have been motivated by a vindictive attitude of certain government officials towards Pan. In court hearings before the case was settled, several witnesses from the TGA gave testimony which appeared to support Mr Selim's argument that the Travacalm problems were seized upon as an opportunity to destroy his company. The firm, valued at about A$300.0 million on the Australian Stock Exchange, collapsed and triggered knock on effects throughout the sector. One small retailer told The Australian that her sales of vitamins dropped by a third after the Pan recall.

Written records destroyed but recording found

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