Healthy Skepticism Library item: 19953

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Publication type: Magazine

Limprecht E
Warning to drug companies: cross the TGA and risk a fine
Australian Doctor 2005 Apr 22
http://www.australiandoctor.com.au/news/warning-to-drug-companies--cross-the-tga-and-risk-

Full text:

Drug companies that refuse to comply with tougher Therapeutic Goods Association requirements will be sanctioned and fined under a new bill due to go before Federal Parliament during next months budget session.

The bill would give the TGA increased powers to punish companies that refuse to issue health warnings, with higher penalties available and improved procedures for recalls.

It is one of several ways the TGA is looking to increase its powers in the lead-up to the establishment of a trans-Tasman regulatory agency in mid 2006.

In framing separate legislation for the formation of the agency, TGA medical director Dr John McEwen told the ABC’s Four Corners program last week that the agency hoped to be able to order large-scale studies of drugs already on the market if there were concerns about their safety.

He said Vioxx, which was withdrawn last year, could not be taken off the market earlier because it was in dispute whether the TGA could force manufacturer Merck to conduct new trials.

Medicines Australia CEO Mr Kieran Schneeman said the industry already undertook extensive pre-market safety testing of medicines and ongoing monitoring after they were approved.

If there is seen to be a need for another layer of safety monitoring in the public interest, Medicines Australia would support this,” he said.