Designation of Adalimumab (Humira) as an orphan drug - AbbVie Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of the Commonwealth of Australia, is a pivotal piece of legislation designed to regulate therapeutic goods within Australia. One of the key objectives of this Act is to ensure that therapeutic goods are safe, of high quality, and effective for their intended use. The Act provides the legal framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. This legislation was introduced to address the need for comprehensive oversight and regulation of therapeutic goods to protect public health and ensure the availability of safe and effective treatments. In August 2015, the Therapeutic Goods Administration (TGA), acting under the authority of the Therapeutic Goods Act 1989, designated Adalimumab (Humira) as an orphan drug for the treatment of specific types of uveitis in adult patients. This designation was made under the Therapeutic Goods Regulations 1990, with the intent to encourage the development and availability of treatments for rare diseases or conditions that affect a small number of people in the population. By recognising Adalimumab as an orphan drug, the TGA aims to facilitate access to this medication for patients with non-infectious intermediate, posterior, or pan-uveitis who have inadequate responses to corticosteroid therapy or experience relapses when corticosteroid therapy is reduced.

Scope and Application

The Therapeutic Goods Act 1989, under which this designation is made, applies to the regulation of therapeutic goods in Australia. Specifically, the designation of Adalimumab (Humira) as an orphan drug pertains to its use for the treatment of adult patients with specific types of uveitis, a condition affecting the eye, that have not responded adequately to corticosteroid therapy or relapse when corticosteroid therapy is reduced. This designation is limited to Adalimumab (Humira) in the form of a solution for injection. The Act applies to the sponsor of the drug, in this case, AbbVie Pty Ltd, and the geographic reach is national, affecting the entire Commonwealth of Australia. This designation does not specify exclusions or exemptions, but it does limit its application to a particular medical condition and form of the drug. The scope of the Act is further defined and potentially extended through subordinate instruments such as regulations and guidelines, which may detail additional requirements and provisions for therapeutic goods, including orphan drugs.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989 in this context are those that permit the designation of a drug as an orphan drug. Section 16J of the Therapeutic Goods Regulations 1990 allows for the designation of certain drugs as orphan drugs if specific conditions are met. In this case, Adalimumab (Humira) has been designated as an orphan drug for the treatment of specific conditions, namely non-infectious intermediate, posterior or pan-uveitis in adult patients who have an inadequate response to corticosteroid therapy or who relapse when corticosteroid therapy is tapered down. The designation is made under subregulation 16J(2) of the Regulations by Dr Anthony Gill, acting as the Delegate of the Secretary. The Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 impose certain obligations on the parties and entities they govern. In this instance, the sponsor of Adalimumab (Humira), AbbVie Pty Ltd, must ensure that the drug is used according to the conditions specified in the designation. This includes adhering to the approved dose form, which is solution for injection, and ensuring that the drug is used solely for the designated indication. The sponsor is also responsible for ensuring that the drug meets the necessary safety, quality, and efficacy standards. The Act and the Regulations also include provisions that outline the consequences for breach. While the specific offences, penalties, or consequences are not detailed in this particular designation, the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 do include general provisions for non-compliance. These may include fines, imprisonment, or both for individuals and entities found to be in breach of the Act or the Regulations. The maximum penalties can vary depending on the specific offence and the severity of the breach. It is important for parties and entities governed by the Act and the Regulations to be aware of these potential consequences and to ensure compliance with all relevant provisions.