Covid rapid antigen test supplier rejects allegations by TGA of ‘serial non-compliance’

A pharmaceutical company supplying rapid antigen tests to Coles and Woolworths has rejected allegations it did not provide up-to-date safety and efficacy data and adequate support to consumers.

On Wednesday the Therapeutic Goods Administration (TGA) fined Hough Pharma $106,560 for “serial non-compliance” with regulatory requirements. All manufactures of therapeutic goods, including tests, drugs and medical devices approved for use in Australia, must continually provide safety and performance data to the TGA as requested.

This information is especially important for newer drugs and devices, because more information about their efficacy and safety becomes available as they are used more widely.

In a statement about Hough Pharma, the TGA said: “In addition to not meeting deadlines for providing information to the TGA, the lack of customer support has been reported by consumers and verified by TGA investigations.”

On Thursday Hough Pharma rejected the allegations, which relate to three of its tests including the self-tests sold by major supermarkets and other retailers.

The managing director, Jackson Hough, said further clinical trials were under way, and the company had “continually provided efficacy, safety and variant data to the TGA to demonstrate our products effectively detect Covid-19 and its variants”.

However, a TGA spokesperson said while Hough Pharma submitted data as required at the time that they applied to the TGA to have their tests approved for use in Australia, this data demonstrated that the tests met the TGA’s minimum requirements for performance and sensitivity.

“As part of the TGA approval, Hough Pharma was also required to provide ongoing information on the sensitivity of their tests to variants as they emerge,” the spokesperson said.

“Whilst Hough Pharma provided some information in relation to the Omicron variant, the TGA requested, on a number of occasions, more detailed information.” The TGA said this information was not provided.

The spokesperson said consumers using the tests could be assured the test did meet minimum regulatory requirements to detect Covid-19 and variants.

But the claimed level of sensitivity is in the process of being validated, they said. Hough claims their test has a high level of sensitivity. Sensitivity levels range from “acceptable” to “very high”.

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“The TGA has engaged the Doherty Institute to validate the level of sensitivity and results from this validation process will be published shortly on the TGA website,” the TGA spokesperson said.

In relation to the allegations of a failure to provide customer support , Hough said: “We pride ourselves on our customer service and consider it a core aspect of our business; a point of difference.”

“We have already been in touch with the TGA in regard to these infringements and have provided the TGA with information that demonstrates our continued performance in relation to customer service,” he said.

“Of the 8,130 calls received to our 1800 number in the first six months of this year, over 94.6% of these were answered the first time. Of the calls that were missed, the overwhelming majority received a call back from our team or called back to our customer service line and were provided with support. Only 3.4% of the unanswered calls were uncontactable.”

The TGA said that the lack of customer support by Hough Pharma was reported to the TGA by consumers as early as January, and verified by TGA investigations.

“This compliance action serves as a reminder to companies to take their obligations seriously,” the TGA spokesperson said. “Any further regulatory action in relation to Hough Pharma is dependent on results of the Doherty validation results and the responses and information received by the TGA from Hough Pharma.”

Guardian Australia understands Woolworths will continue to stock Hough Pharma rapid antigen tests for the time being, while monitoring the situation closely.

Coles did not respond to requests for comment.

All sponsors of home rapid antigen self tests are legally required to ensure that a telephone helpline or online operators are available to provide customer support services from 9am to 7pm (AEST), seven days a week. This support is vital for consumers who may have questions about the test, how it is performed or the interpretation of results.

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