Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Hansard source

My question is to the Minister representing the Minister for Health and Aged Care, Senator Gallagher. In the February Senate estimates hearings Adjunct Professor Skerritt, deputy secretary, health products regulation group, made the following statement:

… there is only one regulator in the world—the USFDA … —that actually looks at individual patient data. The rest of the regulators, like us … take statistically validated analyses of patient data. If there are issues with the individual patient data, the FDA … will raise those issues. …we … do not get individual patient data.

In estimates hearings on 10 November 2022 Adjunct Professor Skerritt said:

We did check the phase 2 and phase 3 clinical trial data from Pfizer …

Minister, please confirm that the TGA simply checked what Pfizer and the FDA sent to them without checking that back to the source material, patient records—meaning they took Pfizer's word for it.