Covid tests being sold at Woolworths and Coles don't meet TGA guidelines, provider gets hit with $106,000 fine
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Covid-19 rapid antigen test supplier Hough Pharma Pty Ltd has been fined $106,560 over "serial" non-compliance with the Therapeutic Goods Administration's guidelines.
According to the TGA, Hough Pharma has been issued eight infringement notices for allegedly "failing to provide information" on the safety and performance of three RATs manufactured by the company.
It was said that the company was not able to meet the deadlines set by the TGA to comply with the requirement — a grave act of non-compliance for the RAT provider. The TGA is a government agency that ensures the instruments pharmaceutical companies produce are safe and perform up to standard.
Additionally, Houghy allegedly failed to provide customer support.
The TGA claimed that they received multiple reports from consumers that they did not receive any customer support from the manufacturer.
The agency reiterated that RAT providers should have telephone or online operators available for customer support.
Hough Pharma received multiple infringement notices from the Therapeutic Goods Administration for allegedly failing to comply with the regulator’s requirements. Credit: NCA Newswire/Dan Peled.
The TGA released a statement regarding Hough Pharma's case, informing the public of the sanctions they imposed on the company for its purported misconduct.
The statement read: “Hough Pharma Pty Ltd has been issued multiple infringement notices for serial non-compliance."
“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."
“The TGA is investigating other sponsors of Covid-19 rapid antigen tests for similar noncompliance.”
Jackson Hough, Hough Pharma's managing director, denied the allegations, saying that the medical supply provider had consistently provided data to the TGA.
He said: “Hough Pharma has continually provided efficacy, safety and variant data to the TGA to demonstrate our products effectively detect Covid-19 and its variants."
RAT providers should provide up-to-date safety and efficacy data to ensure consumers that the instruments are up to standard, according to the TGA. Credit: Lukas Coch/AAP.
A TGA spokesperson commented on Mr Hough's claim, saying that while the company provided the data required at the time that it applied for the approval of its RATs to be used in the country, the data only demonstrated that the tests met the minimum requirements for performance and sensitivity.
The spokesperson said: “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."
“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 that Aussies need to be confident that the medical instruments they use meet the minimum requirements for detecting COVID-19 and its variants.
It should be noted that Hough Pharma provides RATs to Coles and Woolworths.
It is understood that Woolworths will continue to stock the medical devices provided by Hough Pharma for the time being, while monitoring the situation closely.
Coles has yet to respond to requests for comment.
More information on the case can be accessed on TGA's website.
Stay safe out there, folks!
According to the TGA, Hough Pharma has been issued eight infringement notices for allegedly "failing to provide information" on the safety and performance of three RATs manufactured by the company.
It was said that the company was not able to meet the deadlines set by the TGA to comply with the requirement — a grave act of non-compliance for the RAT provider. The TGA is a government agency that ensures the instruments pharmaceutical companies produce are safe and perform up to standard.
Additionally, Houghy allegedly failed to provide customer support.
The TGA claimed that they received multiple reports from consumers that they did not receive any customer support from the manufacturer.
The agency reiterated that RAT providers should have telephone or online operators available for customer support.
Hough Pharma received multiple infringement notices from the Therapeutic Goods Administration for allegedly failing to comply with the regulator’s requirements. Credit: NCA Newswire/Dan Peled.
The TGA released a statement regarding Hough Pharma's case, informing the public of the sanctions they imposed on the company for its purported misconduct.
The statement read: “Hough Pharma Pty Ltd has been issued multiple infringement notices for serial non-compliance."
“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."
“The TGA is investigating other sponsors of Covid-19 rapid antigen tests for similar noncompliance.”
Jackson Hough, Hough Pharma's managing director, denied the allegations, saying that the medical supply provider had consistently provided data to the TGA.
He said: “Hough Pharma has continually provided efficacy, safety and variant data to the TGA to demonstrate our products effectively detect Covid-19 and its variants."
RAT providers should provide up-to-date safety and efficacy data to ensure consumers that the instruments are up to standard, according to the TGA. Credit: Lukas Coch/AAP.
A TGA spokesperson commented on Mr Hough's claim, saying that while the company provided the data required at the time that it applied for the approval of its RATs to be used in the country, the data only demonstrated that the tests met the minimum requirements for performance and sensitivity.
The spokesperson said: “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."
“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 that Aussies need to be confident that the medical instruments they use meet the minimum requirements for detecting COVID-19 and its variants.
It should be noted that Hough Pharma provides RATs to Coles and Woolworths.
It is understood that Woolworths will continue to stock the medical devices provided by Hough Pharma for the time being, while monitoring the situation closely.
Coles has yet to respond to requests for comment.
More information on the case can be accessed on TGA's website.
Stay safe out there, folks!
