Two bills in the national parliament provide a snapshot of our health regulatory system, and just like a smoker’s lungs, it’s not a pretty picture. The bills show that we’re slow in fixing regulatory incapacity…
The class action against the implant manufacturer has fallen over and despite the TGA’s failings, victims can’t sue the regulator.
Ilaria Gallo
The announcement this week by plaintiff law firm Tindall Gask Bentley that it was abandoning a class action against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates…
This class of drug poses significant risks of misuse and dependence, paradoxical reactions, disinhibition, amnesia and intoxication.
Jacek Becela
The body responsible for regulating drugs in Australia, the Therapeutic Goods Administration (TGA), is poised to decide whether to restrict access to benzodiazepines, such as Xanax, Valium and Normison…
How can you tell what products might be of use and which ones will only lighten your wallet?
Image from shutterstock.com
Australia’s complementary and alternative medicine (CAM) industry is worth about A$4 billion annually. Around two thirds of Australians use CAM – which includes therapies such as chiropractic and naturopathy…
The biggest delay is arguably at the stage where sponsors can exert the most control over timing.
Chris Kelly
The Australian government introduced a controversial delay to the approval process for subsidised medicines last year, in an attempt to cut costs. We decided to examine the timelines of the approval process…
Recent consultations found continued inaction on regulatory matters means the community has lost trust in the TGA.
Pharmacare Laboratories' website
Pharmacare Laboratories is facing a new complaint about its Kids Smart homeopathic medicines amid concerns parents who use the products may delay seeking medical treatment.
The complaint – lodged by a…
This product is being sold despite being removed from the Australian Register of Therapeutic Goods by the TGA.
Ken Harvey
I submitted a complaint about the promotion of “FatBlaster Reducta” (ARTG no: 176366) to the Therapeutic Goods Administration in March 2011. The product is a “complementary medicine” containing an extract…
Australia has almost no capacity to fill international medicine shortages.
artisrams
The earthquake in the Northern Italian town of Medolla this May devastated the local community, killing 17 people and leaving 14,000 homeless. Because Medolla is the manufacturing epicentre of the Italian…
The CHC Complaints Resolution Committee did not consider a $675 gift to be “undue influence, pressure or unfair tactics”.
Bradley Stemke
In April 2012 Swisse made the following offer to GPs, “For those who on-sell full sized Swisse Practitioner products, Swisse will sponsor the full cost for you or one of your staff members to complete…
Pharmaceutical companies undertake clinical trials to determine whether a potential new drug meets the requirements for market authorisation.
Chain of figures photo from www.shutterstock.com
New medicines must be approved as safe, efficacious and of good quality before they can be prescribed. But authors of two recent articles in the British Medical Journal argue that governments should introduce…
Nurofen was criticised for claiming its products “target” different sites of pain.
samcatchsides.com/flickr
In 2010, the promotion of the Nurofen range of products “targeting” migraine, back pain, tension headache and period pain was awarded a CHOICE shonky award.
This was because all these products contained…
The dietary supplements, nutraceuticals or vitamins industry makes a lot of money.
hit thatswitch/Flickr
Pills made from “wild krill” (apparently so much better for you than domestic krill)? Antioxidants from exotic plants, chlorophyll or the “Sicilian Blood Orange”? Promises of extra vitality, vim and vigour…
The Conversation’s health coverage: policy, chiropractic, obesity and medicine.
AAP, Planetc1.com, Puuiki Beach, LJA Kliche
In The Conversation’s first editorial meeting editor Andrew Jaspan explained what he wanted to achieve with the site: a more informed level of debate, based on evidence, research and expert opinion.
It…
The TGA investigates just over half of all safety complaints it receives about medical devices.
Flickr/johanlb
The recent recalls of metal-on-metal hip replacements and PIP breast implants highlight the potential for widely used medical implants and devices to cause serious harm, despite having passed all the required…
The TGA is still slow to act on products making dubious weight-loss claims.
puuikibeach
Little seems to have changed inside the Therapeutic Goods Administration (TGA). And that’s despite two years of reviews into the shortcomings of its regulatory processes and the release, late last year…
The TGA-banned painkillers are no more effective than paracetamol for acute pain.
Cayusa/Flickr
The Administrative Appeals Tribunal has granted pharmaceutical company Aspen Pharmacare a legal stay against the Therapeutic Goods Administration’s (TGA) ban on some of its products.
The company took…
MP Catherine King, who announced TGA reforms on Thursday afternoon, speaks to reporters on Aug. 11, 2011.
AAP/Melissa Lahoud
The government has just announced its response to a series of reviews of the Therapeutic Goods Administration over the past 18 months. The announcement was brought forward after a summary of the reforms…
Some complementary medicines fill a medical need while others are of no value whatsoever.
nicholaslaughlin
Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry…
Johnson and Johnson’s faulty Du Puy hip implants leeched metal into the tissue of some recipients.
Okadots
With joint replacement surgery becoming increasingly common, the flap over a large recall of De Puy hip implants has thousands of Australians worried about the quality and longevity their own hip replacements…
Vitamins, minerals and herbal therapies should live up to the claims on their packaging.
Peter Sunna
Two out of three Australians use complementary medicines to boost their nutrition, alleviate various symptoms and improve their overall health and well-being. There are around 10,000 products to choose…
The US FDA is moving to regulate medical mobile apps linked to instruments it currently oversees.
The US Food and Drug Administration (FDA) is proposing to regulate some medical mobile applications, or apps, in an apparent bid to protect consumers from harming themselves or others.
At first sight…
There’s growing pressure on the TGA to disclose details of its pre-market reviews of approved medications.
Tom Varco/Wikimedia commons
The latest report on Therapeutic Goods Administration (TGA) activities – this one concerning transparency – has just been made public, two weeks after it was submitted to the government.
At least this…
An FDA audit of CSL’s laboratories has found the company doesn’t follow good manufacturing practice.
AAP
The US Food and Drug Administration (FDA), has just issued a warning letter about the safety of CSL’s influenza vaccine, Fluvax. The letter follows FDA’s latest annual inspection of CSL laboratories and…
Screen shot at PM.
Malcolm Vickers/Australian Skeptics (Victorian Branch)
The SensaSlim company’s recent defamation suit against Dr Ken Harvey of La Trobe University highlights some of the regulatory problems facing complementary products in Australia.
Dr Harvey initiated a…
On March 18, 2011, I submitted my first complaint about the promotion of SensaSlim to appropriate authorities – the Complaint Resolution Panel (CRP) which hears complaints about alleged breaches of the…
