1961: Dame Joan Sutherland is named Australian of the Year, the first episode of Four Corners airs on television, and the dangerous medicine thalidomide is withdrawn from the Australian market after being linked to severe birth defects.
Originally developed in Germany as a sedative, thalidomide was used in Australia in the 1950s and early 60s to relieve nausea in pregnancy. Unknown to mothers taking thalidomide for their morning sickness, the medicine could cause birth defects such as shortened or absent limbs, blindness, deafness or malformed internal organs.
Worldwide, more than 10,000 children are estimated to have been born with birth defects because of thalidomide use, with an estimated 40% of these children dying within a year. Thalidomide survivors continue to live with the impacts of the drug today.
At the time, Australia did not have a system for evaluating the safety of medicines before they were permitted on the market. Although thalidomide was ultimately removed from the market, this was only after many pregnant women in Australia had already taken the medicine.
What is the TGA?
The thalidomide tragedy demonstrated to Australians that medicines and other therapeutic goods need to be evaluated for safety and efficacy (that the medicine does what it says it will). A series of regulatory changes culminated in the Therapeutic Goods Act 1989, which established the Therapeutic Goods Administration (TGA) as Australia’s national regulator of medicines and medical devices.
When a company wants to sell a prescription-only medicine like thalidomide in Australia, we check the evidence first, and will only approve the medicine if the balance of benefit and risk is acceptable for a particular condition. Then once the medicine is approved for supply, we continue to monitor it to make sure it meets our required standards. In this way, we protect the health of the Australian public.
Today, thalidomide is only supplied in strictly controlled conditions in relation to treatment for leprosy and some cancers, and never to pregnant women.
What is a therapeutic good?
In general, a therapeutic good is any medicine or medical device.
This includes everyday goods, such as vitamins and sunscreens, but also includes goods that can treat serious conditions, such as prescription medicines and surgical implants. Some other goods, such as blood products and vaccines, are also regulated by the TGA.
There are some things we don’t regulate such as food, cosmetics, veterinary medicine, and health professionals. But it is worth noting that any product that makes a health claim, such as ‘helps reduce body pain’, will likely be considered a therapeutic good, and regulated as one.
How do we regulate therapeutic goods?
We place controls on therapeutic goods proportionate to their risk. So a low-risk product such as a bandage might be freely sold at supermarkets, while a higher-risk product such as a heart medicine might only be available through a doctor’s prescription.
We use different strategies to regulate therapeutic goods:
- Pre-market assessment. Therapeutic goods must be either listed, registered or included on the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia. Listed goods are not evaluated for efficacy at the time of listing, but must meet other requirements, such as only using specified low-risk ingredients. Registered goods such as prescription medicines are always fully evaluated for quality, safety and efficacy. Registration involves analysis of thousands of pages of documents, and the average time it takes to register a medicine on the ARTG is 11 months.
- Post-market monitoring and enforcement. We monitor goods after sale by collecting reports of side effects, inspecting manufacturers, and by performing both random and targeted testing. We also have a continuum of tools available to achieve compliance, from issuing a formal warning through to criminal prosecution.
- Manufacturing standards. We require all Australian manufacturers of medicines to hold a license, which is only granted if they can demonstrate that quality is built into their products during manufacture. Manufacturers of medical devices must provide evidence of the safety, performance and benefit of each device.
How can I learn more?
The TGA touches the life of every Australian, whether it is through prescription medicines, vitamins, vaccines, the regulation of therapeutic goods advertising, or medical devices.
When a company wants to sell a medicine like thalidomide in Australia, we are the people who check the evidence and balance the benefit against the risk.