163. Hasn’t Pfizer and Co broken the Therapeutic Goods Act 1989 by failing to report all the adverse events from their trials and post marketing surveillance (refer to patient records)? Under paragraph 28(5)(ca) of the Act, you MUST retain records pertaining to the reporting requirements and safety for your medicine. (page 29 of 44) 164. What is the legislation that details the TGAs responsibilities in regard to post market safety surveillance data? Why hasn’t the TGA sought to allay the publics fear over data that shows an alarming number of adverse events and poor quality assurance practices? 202. Does the TGA do post marketing surveillance at all over and above that of the sponsor? If not, why not? What is the point of having an independent regulator if it doesn’t do independent safety testing?

Question Number: 181
PDR Number: SQ22-000551
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 163 The Therapeutic Goods Administration (TGA) is not aware of any failure by Pfizer to comply with their reporting or record-keeping obligations related to adverse events and post market surveillance.

Question 164 The Therapeutic Goods Act 1989 contains a range of powers for the Secretary of the Department of Health and Aged Care (and his delegates) to undertake post-market monitoring of therapeutic goods. These include, for instance, the power to require the provision of information or documents about therapeutic goods that are approved for marketing in Australia, and the power to impose requirements relating to the public notification and recall of therapeutic goods in specified circumstances. The Act also contains criminal offences and civil penalties that may apply where a person contravenes the Act (e.g. in relation to tampering with therapeutic goods or supplying counterfeit therapeutic goods), and provides for the issuing of infringement notices for alleged contraventions that would constitute an offence of strict liability, or a civil penalty. Regulation 15A of the Therapeutic Goods Regulations 1990, specifies that the sponsor must comply with reporting and record-keeping requirements set out in the “Pharmacovigilance Responsibilities of Medicine Sponsors.” This document describes the reporting and record-keeping requirements and recommended approaches to monitoring, collecting and managing safety data. The sponsor is required to report to the TGA, within 15 calendar days, all serious adverse reactions associated with the use of their medicines that occurred in Australia. The sponsor must keep records of all adverse reactions including non-serious adverse reactions indefinitely for the life of the medicine and for a period of five or 10 years after removal from the ARTG as applicable. The sponsor should include all adverse reactions in their ongoing safety monitoring activities and must report to the TGA, within 72 hours of local awareness, any new safety issues that they detect or become aware of e.g. from international regulatory agencies. Reporting and record keeping obligations for adverse reaction reports and significant safety issues that arise from Australian clinical trials are outlined in the “Australian clinical trial handbook” and the guidance published by the NHMRC: “Safety monitoring and reporting in clinical trials involving therapeutic goods”. Additionally, all adverse reactions from post marketing surveillance, relevant information from post-authorisation studies or clinical trials in unauthorised indications or populations must be presented in a Periodic Safety Update Report (PSUR) where one is required or supplied to the TGA upon request in the requested format. As a condition of registration, the TGA requires the submission of monthly summary safety reports for the first six months, and thereafter at the TGA’s specified interval, and six-monthly PSURs for all COVID-19 vaccines that are supplied in Australia. The TGA has published 79 issues of the COVID-19 vaccine safety report. This report provides information to the public about the safety of the vaccine, and communicated information for emerging safety signals, for example with thrombosis with thrombocytopenia syndrome with Vaxzevria, and myocarditis and pericarditis associated with mRNA vaccines. While the Database of Adverse Event Notifications – medicines provides transparency around the adverse events received by the TGA, the COVID-19 vaccine safety report provides context to this information, thereby reassuring the public through the provision of balanced information about the known safety profile of the vaccines, as well as the benefits that vaccination has demonstrated in Australia and internationally.

Question 202 The TGA undertakes a significant amount of post marketing surveillance of therapeutic goods beyond that of the sponsor. The TGA closely monitors the safety of COVID-19 vaccines under the most intensive safety monitoring ever conducted of any vaccines in Australia. The TGA relies on its own thorough assessment of the available data to ensure that the Product Information documents provide up-to-date safety information about the COVID-19 vaccines. The TGA’s assessment of vaccine safety is based on careful evaluation of evidence from well conducted clinical trials and robust post-market monitoring. When investigations identify new safety information, the TGA takes prompt regulatory action, which includes requiring the sponsor to update the Product Information used by health professionals, including those administering vaccines.