Shadow minister Chris Bowen has accused health minister Greg Hunt of intervening in the TGA's consideration of a product sponsored by a company whose chair has made a number of financial donations to the Coalition.
Mr Bowen was responding to a television report following the release of documents in response to a Freedom of Information request.
The documents relate to the TGA's consideration of a DIY-flu test sponsored by Ellume. The Brisbane-based company is focused on the development and commercialisation of digital diagnostic products.
Its chair, Paul Darrouzet, has donated several hundred thousand dollars to the Coalition since 2014, said Mr Bowen.
"Straight after the Federal election, Minister Hunt requested the TGA review the Ellume device amongst other DIY-flu testing products," said Mr Bowen in a statement.
According to Nine, the documents show TGA head John Skerritt telling colleagues in an email: "Had another call from the MO [minister's office] - they are very keen for this issue to be reviewed."
Nine said the documents also show the regulator advising caution and wanting to ensure consistency in its approach to home-based DIY-flu tests.
"This unprecedented ministerial intervention into a review of the regulation of technology after such a large donation was made to the Liberal Party raises huge concerns about the Minister’s integrity," added Mr Bowen.
A spokesperson for Mr Hunt dismissed the claim. "The Therapeutic Goods Administration advised Australia was 'some years behind some other medium-large regulators' on this matter," they said.
"The TGA indicated that a review would require ministerial support as standard practice. A formal request for a review then followed with the minister's consent in line with the TGA advice."