Supply of the product Dasatinib (Sprycel) by Bristol-Myers Squib Pty Ltd

Overview

The Therapeutic Goods Act 1989 is foundational legislation in Australia, enacted to regulate the supply, import, export, and advertising of therapeutic goods. This Act was introduced to address the need for a cohesive and effective framework to ensure the safety, quality, and efficacy of therapeutic goods available to the public. The Therapeutic Goods Administration, under the auspices of the Department of Health, is the body responsible for the oversight and enforcement of this Act. The policy objective underpinning the Act is to protect public health by ensuring that therapeutic goods meet necessary standards and are appropriately marketed and supplied. In February 2014, the delegate of the Secretary, exercising powers under the Act, granted consent for the supply of a specific pharmaceutical product, dasatinib (SPRYCEL) 20 mg tablets, under certain conditions. This consent was issued to address a compliance issue with the product's labelling, specifically the use of an outdated sponsor address on the product label. The consent was granted with conditions to ensure that the issue was rectified and that consumer queries were appropriately managed during the transition period.

Scope and Application

The Therapeutic Goods Act 1989, under sections 14 and 14A, pertains to the regulation of therapeutic goods within Australia, ensuring they meet the necessary safety, quality, and efficacy standards. This Act applies to all entities involved in the supply, manufacture, and distribution of therapeutic goods, including pharmaceuticals, medical devices, and biologicals. The scope of this legislation is extensive, covering both Commonwealth and state jurisdictions, and it applies to all therapeutic goods that are intended for use in Australia. The Act provides the Therapeutic Goods Administration (TGA) with the authority to grant consent for the supply of therapeutic goods that do not fully comply with certain legislative requirements, subject to specific conditions designed to protect public health. In this instance, the consent granted by the delegate of the Secretary allows Bristol-Myers Squibb Pty Ltd to supply dasatinib (SPRYCEL) 20 mg tablets with labels that bear an outdated sponsor address, which does not comply with the Therapeutic Goods Order 69. This consent is limited to the supply of the product until the end of September 2014, during which time the sponsor's address on the product labels must be updated to reflect the new address. Additionally, the arrangement for handling consumer queries or complaints must ensure they are promptly directed to the new address.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia. Specifically, Section 14 and 14A of the Act pertain to the consent for the supply of therapeutic goods that do not comply with the Therapeutic Goods Regulations. In this instance, the delegate of the Secretary of the Department of Health has given consent for the supply of dasatinib (SPRYCEL) 20 mg tablets (Section 14(1)). This consent allows Bristol-Myers Squibb Pty Ltd to supply the product despite it not meeting the requirements set out in paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69, which concerns the general requirements for labels for medicines. Under Section 15(1) of the Act, the consent provided by the delegate is subject to certain conditions. These conditions dictate that the consent to supply the non-compliant product applies only until the end of September 2014. Additionally, the consent applies only to the product labels that currently bear the previous sponsor address, 556 Princes Highway, Noble Park, Victoria 3174, instead of the new address, 4 Nexus Court, Mulgrave, Victoria 3170. It is important to note that no other changes have been made to the product itself beyond the address on the label. Entities governed by the Act, such as Bristol-Myers Squibb Pty Ltd, are required to adhere to the conditions specified in the consent. This includes ensuring that all consumer queries or complaints are promptly forwarded to the new address provided. By doing so, they maintain compliance with the regulatory framework and ensure consumer protection. Breach of the conditions set forth in the consent for supply can result in various consequences. While the specific civil or criminal penalties for non-compliance with the Act are not detailed in this particular notice, it is understood that failure to adhere to the Therapeutic Goods Regulations can lead to enforcement actions, including fines and other penalties. The Act provides for a range of enforcement measures to ensure that therapeutic goods meet the required standards, thereby safeguarding public health and safety.