Why does Australia allow unsafe medication to stay on the market?

Recently the Consumers Health Forum highlighted how big pharmaceutical companies are effectively vetoing the nation’s drug safety regulator, the Therapeutic Goods Administration (TGA), and bypassing regulation designed to protect consumers.

In a long-running saga, the TGA banned a number of dextropropoxyphene-containing drugs including Di-Gesic and Doloxene on safety and efficacy grounds, citing interference with the electrical conductivity of the heart as a major concern. However, the pharmaceutical company involved, Aspen Pharmaceuticals, appealed to the Administrative Appeals Tribunal (AAT), challenging the ruling on a number of technical grounds.

The AAT ordered the drugs to remain on the shelves, albeit with heavy warnings on the packaging and direct communication with pharmacists.

The AAT then found that the TGA should overturn its ban, and allow the drugs to stay on the market, unrestricted aside from normal prescribing rules, and remitted the decision back to the TGA.

Last month the TGA confirmed its original decision, and the parties are now back before the AAT.

“A number of other jurisdictions such as the US, UK, European countries and New Zealand have already removed these products from their markets in response to the same concerns,” CHF CEO Carol Bennett said.

“The TGA does not often ban products.”

“The TGA thought it appropriate to fully remove Di-Gesic, Doloxene and other medications from the market and this should be enough to ensure these products are not available to the public unless they are proven to be safe and effective.”

CHF CEO Carol Bennett said the saga demonstrated serious flaws in consumer protections, designed by lawmakers to put scientific and clinical evidence at the forefront of decision making.

“It does not bode well for future regulation that the very thorough and painstaking review of medications undertaken by the TGA can be easily overturned by a tribunal on a very narrow technical ground in the face of substantial evidence,” Ms Bennett said.

“I think all Australians should be very concerned by this episode, and the apparent ease with which a major pharmaceutical company can stall the actions of the nation’s drug regulator.”

“At the end of the day, consumers trust that the products they are being sold are safe and effective, and will not potentially harm their health.”

This article was originally published by CHF in their Consumers Shaping Health Newsletter.

A longer article by CH Director Carol Bennett  was published in Crikey  clicking here.

1 Comment on "Why does Australia allow unsafe medication to stay on the market?"

  1. I have been taking this medication following serious back surgery in 1993. I take it stricly according to instructions and don’t drink (another serious contra indication). I was put on this medication after 2 years at RNSH pain clinic, as absolutely no other means could dull my chronic pain. I am now without any means to combat this pain. I feel aggrieved that I should suffer because of the misuse of this medical by others. If they wish to misuse the medication it should be on their heads, not those who follow instructions to the letter.

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