The supplier of a rapid COVID-19 test sold in Woolworths and Coles has rejected allegations it did not provide data to support the performance of its tests and its poor customer service after the medicines regulator slapped it with a $106,560 fine.
Hough Pharma, which makes the tests supplied at major retailers, was given the infringement notices over allegations it did not provide evidence to the Therapeutic Goods Administration (TGA) when requested about the safety and performance of three rapid tests.
The TGA also claims that despite being required to have telephone and online customer service operators available seven days per week between 9. 00am and 7. 00pm, the company was found to have a lack of customer support.
This compliance action serves as a reminder to companies to take their obligations seriously, the TGA said in a statement.
However, Hough Pharma’s managing director, Jackson Hough, told the Sydney Morning Herald and The Age via email that the company had consistently provided data to the regulator.
Hough Pharma has continually provided efficacy, safety and variant data to the TGA to demonstrate our products effectively detect COVID-19 and its variants, he said.
He added that the company rejected allegations of a lack of customer service. It is our intent to always deliver strong community engagement, holding our responsibility to provide safe and effective products for use by the Australian public above all else, Hough said.
We operate a 1800 number, in addition to email and SMS response options that are provided from 7 am–9 pm, seven days a week. We are committed to the highest levels of customer support and product performance.
The business has been in touch with the TGA to provide evidence that its customer service meets requirements.
Hough Pharma tests remain approved for sale and will still be available in the Australian market.
The TGA has warned local sponsors of rapid COVID tests that it is already looking into whether other providers are meeting their requirements. The TGA is investigating other sponsors of COVID-19 rapid antigen tests for similar non-compliance, the watchdog said.
Before rapid tests can be sold, suppliers must provide detailed data on their efficacy to the regulator.
These companies must also abide by other rules, including that helplines are available seven days a week so that customers can get in touch with any concerns. Providers must also meet post-market safety rules, including proactively monitoring whether their tests are impacted by new variants of the virus, as well as supplying information to the TGA about safety and efficacy when asked.
The TGA has been assessing test data to make sure rapid tests on the market remain suitable for new variants, but this process is ongoing.
The TGA has been contacted for further comment.
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