Supply of the product Dapagliflozin by AstraZeneca

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods, including medicines, medical devices, and other health-related products, ensuring their quality, safety, and efficacy for the Australian public. The 2014 amendment, as evidenced by C2014G00779, addresses specific issues related to the labelling and supply of therapeutic goods, particularly in instances where there are changes in sponsorship or labelling discrepancies. This legislative action was taken by the Commonwealth of Australia's Department of Health, specifically through the Therapeutic Goods Administration, aiming to uphold the standards set out in the Therapeutic Goods Orders. The policy objective here is to facilitate the continued supply of necessary therapeutic goods while ensuring compliance with labelling requirements, thereby protecting public health and maintaining trust in the therapeutic goods market. The 2014 notice concerning dapagliflozin (FORXIGA) 10 mg film-coated tablets highlights a particular instance where the Act's flexibility was applied to allow the supply of a product that did not fully conform to labelling standards. This intervention underscores the Act's role in balancing regulatory compliance with the practicalities of therapeutic goods distribution, ensuring that critical medications remain available to patients under carefully controlled conditions.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products including medicines, medical devices, blood, and tissues. This Act applies to both individuals and entities that manufacture, supply, or advertise therapeutic goods within Australia, with its reach extending across the Commonwealth, including all states and territories. The Act sets out the regulatory framework for the approval, quality, safety, and efficacy of therapeutic goods, as well as the processes for listing, advertising, and the prohibition of misleading or deceptive conduct related to these goods. Certain exclusions and exemptions are provided under the Act, such as for goods used for personal or domestic purposes, or for research and experimental use. The Act also allows for the creation of subordinate instruments such as regulations and orders, which can further specify the requirements and standards applicable to therapeutic goods, thereby extending or restricting the application of the primary Act. In this particular case, the Act facilitates the temporary consent for the supply of a specific medicinal product, dapagliflozin (FORXIGA), under particular conditions despite it not fully conforming to certain labelling requirements stipulated in Therapeutic Goods Order No. 69. The consent granted is limited to a period of 12 months and is contingent on specific conditions being met, such as the use of labels that include both previous and current sponsor details, and the establishment of arrangements to redirect all correspondence to the current sponsor, AstraZeneca. This instance illustrates how the Therapeutic Goods Act 1989 allows for flexibility in the regulation of therapeutic goods, enabling specific provisions to be made to address particular circumstances while maintaining the overarching regulatory standards.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989, as referenced in the notice, concern the supply of a particular therapeutic good, dapagliflozin (as propanediol monohydrate) (FORXIGA) 10 mg film coated tablets blister pack, under certain conditions. Specifically, section 14 and 14A of the Act pertain to the granting of consent by the delegate of the Secretary of the Department of Health for the supply of therapeutic goods that do not conform with specified requirements, in this case, those outlined in Therapeutic Goods Order No. 69 (TGO 69). The notice clarifies that the consent is given for a period of 12 months, limited to approximately 82,500 packs of the product supplied by AstraZeneca. The obligations imposed by the Act on the parties involved, particularly AstraZeneca, include ensuring that the carton label of the product states both the previous sponsor's contact details and the current sponsor's (as the distributor) details. Additionally, it is mandated that all correspondence be redirected to the current sponsor, AstraZeneca. The Act also requires that no other changes be made to the product during the period of consent. These conditions are designed to ensure that the product remains compliant with regulatory standards while addressing the specific issue of outdated sponsor information on the label. Failure to comply with the conditions set forth in the consent or any other provisions of the Therapeutic Goods Act 1989 may result in various legal consequences. The Act includes provisions for offences and penalties, although the specific penalties are not detailed in the notice. Generally, breaches of the Act can lead to both civil and criminal penalties, which may include fines and imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any relevant case law or regulatory guidelines. However, the notice does not specify the maximum penalties applicable to this particular case, leaving that to be determined by the courts or regulatory authorities in the event of a breach.