Supply of exemestane (AROMASIN) 25 mg tablet blister pack by Pfizer Australia

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the quality, safety, and efficacy of therapeutic goods, including medicines and medical devices, within the country. The Act was introduced to address the need for a comprehensive legal framework governing the supply, advertising, and regulation of therapeutic goods, ensuring they meet safety and efficacy standards before reaching consumers. In this context, the Therapeutic Goods Administration, under the Department of Health, was established to administer the Act and ensure compliance with its provisions. The policy objective is to protect public health by ensuring that only therapeutic goods that meet the required standards are available in the Australian market. On September 16, 2013, the delegate of the Secretary of the Department of Health granted consent for the supply of exemestane (AROMASIN) 25 mg tablet blister packs by Pfizer Australia Pty Ltd, subject to specific conditions under sections 14 and 14A of the Therapeutic Goods Act 1989. This consent was issued for the supply of batches U955A and V220B of the product, which did not conform to certain labelling requirements of Therapeutic Goods Order (TGO) 69. The consent was provided with the condition that the carton and blister foil labels for the affected batches must match those provided in the Company's email dated September 6, 2013, and that each supply of these batches must be accompanied by a Dear Health Care Professional/Pharmacist letter dated September 16, 2013, to ensure compliance and inform healthcare professionals of the labelling issues.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, ensuring that these goods meet specific safety, quality, and efficacy standards. Section 14 and 14A of the Act permit the delegate of the Secretary of the Department of Health to grant consent for the supply of therapeutic goods that do not conform to certain legislative requirements, provided certain conditions are met. In this instance, the Act applies to Pfizer Australia Pty Ltd and specifically to the supply of exemestane (AROMASIN) 25 mg tablet blister packs that do not meet the labelling requirements of TGO 69. This consent is limited to the batches U955A and V220B, as specified in the approval, and requires that each supply of these batches be accompanied by a designated letter to health care professionals or pharmacists. The scope of the Act is thus confined to the specified entity, product, and batches, with the consent subject to conditions that must be strictly adhered to in the supply of the therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the supply and use of therapeutic goods in Australia, ensuring they are safe, of high quality, and properly represented. Under section 14, the Secretary of the Department of Health may consent to the supply of therapeutic goods that do not conform to certain standards, while section 14A allows for the supply of goods that do not meet the requirements of Therapeutic Goods Orders (TGO). In this instance, section 14A notice (paragraph 163A(1)) was issued for the supply of exemestane (AROMASIN) 25 mg tablet blister packs by Pfizer Australia Pty Ltd. The notice was given on September 16, 2013, by the delegate of the Secretary, and it permits the supply of batches U955A and V220B of the product that do not comply with certain labelling requirements specified in TGO 69 (subsection 15(1)). The obligations imposed by this notice on the parties involved are quite specific. Firstly, the Company must ensure that the supply of the affected batches adheres to the conditions outlined in the notice. This includes using the carton and blister foil labels provided in the Company’s electronic mail of September 6, 2013. Additionally, each supply of the affected batches must be accompanied by the Dear Health Care Professional/Pharmacist letter dated September 16, 2013. This letter likely contains important information and instructions regarding the use of the non-compliant product, ensuring that healthcare professionals and pharmacists are aware of the specific conditions governing its use. Failure to comply with the conditions of the notice may result in serious consequences. Under the Act, breaches of its provisions or the Therapeutic Goods Regulations can lead to both civil and criminal penalties. For instance, section 22(1) of the Act provides that any person who contravenes the Act or the Regulations is liable to a fine. The maximum penalties for such offences can vary widely depending on the nature and seriousness of the breach. For example, section 22(2) stipulates that for a corporation, the maximum penalty can be up to 500,000 Australian dollars for a single offence, and potentially higher if the offence is ongoing. Additionally, individuals responsible for the management of the corporation can face personal penalties, including fines and imprisonment, under sections 22(3) and 22(4). These stringent penalties underscore the importance of adhering to the conditions specified in the notice and the overall regulatory framework governing therapeutic goods in Australia.