A major supplier of Covid-19 rapid antigen tests to Coles and Woolworths has been fined $106,560 for allegedly failing to keep Australia’s drug regulator informed about the safety and performance of the tests.
Hough Pharma Pty Ltd was issued multiple infringement notices by the Therapeutic Goods Administration (TGA) on Thursday for what the agency described as “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 approved in response to a rare illnesses, or to a crisis such as the pandemic, because more information about their efficacy and safety becomes available as they are used more widely.
Suppliers and manufacturers of rapid antigen tests must also ensure that telephone helpline or online operators are available to provide customer support from 9am to 7pm (AEST), 週7日.
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.”
“The TGA is investigating other sponsors of Covid-19 rapid antigen tests for similar non-compliance. This compliance action serves as a reminder to companies to take their obligations seriously. Suppliers of therapeutic goods must meet their ongoing post-market safety, performance vigilance, and monitoring commitments.”
Hough Pharma has been contacted for comment. Based on the studies performed by the manufacturer, the Hough Pharma home Covid test has a clinical sensitivity greater than 90% positive percent agreement. The positive percent agreement is the proportion of individuals who tested positive to Covid-19 using the rapid antigen self-test, compared with those who tested positive using a more sensitive and reliable PCR nasal swab test.
A 25-pack of Hough Pharma nasal swabs sells for $145 at Woolworths, 一方 Coles sells a five-pack for $40. Both supermarkets have been contacted for comment on whether they will continue to stock the tests.
The TGA is conducting a post-market review of all rapid-antigen tests approved for use in Australia, including assessing their ability to detect emerging variants.