The TGA has effectively confirmed companies can issue a media release with links to websites containing publicly available information promoting their PBS-listed medicine brands and it will not be considered direct-to-consumer advertising as long as it is 'factual and balanced', the intended audience understands it is designed for them and the impact on the wider public is assessed as low.
The TGA responded to questions from BioPharmaDispatch about the materials recently issued by the so-called Targeted Therapies Alliance in relation to certain PBS-listed medicines for the treatment of inflammatory bowel disease.
Background
The Targeted Therapies Alliance, which is led by NPS MedicineWise, will receive over $8 million from the federal government to deliver around $55 million in savings from the reduced use of biologic disease-modifying anti-rheumatic drugs (bDMARDs). It has released three new resources on treatment options for inflammatory bowel disease.
"New resources are now available to help people living with inflammatory bowel disease keep their condition under control," said the alliance in a recent media release that also included links to the websites containing the publicly available resources.
The three resources promote by medicine and even brand name the use of thiopurines for Crohn’s disease and ulcerative colitis, a range of non-bDMARD treatments for ulcerative colitis and low-dose methotrexate for Crohn’s disease.
They do not even mention PBS-listed bDMARDs as an option.
What the TGA said in response to questions
In response to questions about the legality of the resources, the regulator said, "The TGA is of the view that the materials support accepted clinical guidelines that non-bDMARD treatments are the first-line treatments for various autoimmune diseases and is primarily a resource which provides factual and balanced information to enhance communication between affected individuals and their treating medical practitioner."
The publicly available and medicine branded resources do not delineate between lines of treatment and forms of the disease or even acknowledge the existence of PBS-listed bDMARDs. Apparently, that still qualifies as "factual and balanced information".
"The TGA is also of the view that the campaign’s audience would understand this as the intent of the material, and that therefore the advertising rules do not apply," said the regulator.
This is a remarkable statement. Why the ban on direct-to-consumer advertising if patients can self-identify as the intended and informed audience?
In response to a number of follow-up questions, the regulator said, "The TGA has reviewed the materials and determined that taken as whole they provide a range of information resources for health professionals and consumers about the use of non-bDMARDS. Taken as a whole the fact that non-bDMARDS are a first-line treatment is quite clear."
Maybe that would be quite clear to a clinician but the materials 'taken as whole' do not in any way delineate between lines of treatment or forms of the disease. It is also important to point out that the resources explicitly identify patients as the 'intended audience'. In fact, the resources are a case study in direct-to-consumer advertising.
The regulator added, "The TGA agrees that the audience of the material is not confined to affected individuals and their treating medical practitioner however in considering the likely effect of the material, the audience to whom the material is directed, as well as the impact for the general public, is taken into consideration."
It did not point to any objective criteria for assessing the "impact for the general public". In addition, its previous decisions on advertising suggest it takes a very conservative approach to what it considers impact on the general public, just not on this occasion.
Apparently, it comes down to the intended audience's understanding
It seems that in the view of the TGA, as long as the intended audience understands the branded resources are for them and "impact for the general public" is minimal, even though they have been promoted via a media release, are in the public domain and freely available on an easily accessible website, they will not be considered advertising and in breach of the law.
Yet how would a member of the public accessing the resources be expected to know whether or not they are the intended audience given the resources do not delineate between mild, moderate or severe forms of disease?
What is a patient with severe symptoms of an inflammatory bowel disease meant to make of these resources? How are they meant to know they are not the intended audience?
These are the reasons people support a ban on direct-to-consumer advertising.
The TGA is endorsing direct-to-consumer advertising of prescription medicines
During Senate Estimates in early June, TGA head John Skerritt was emphatic in saying he "personally hopes" Australia never lifts its current ban on direct-to-consumer advertising of prescription medicines and vaccines.
"I should clarify that it is a consequence of one of the things that personally I hope Australia never follows, and this is the US widespread advertising of prescription medicines directly to the public. It is legal and extremely commonplace," he said.
What ban in Australia?
In defending its non-action on the resources produced by the Targeted Therapies Alliance, the regulator has effectively contradicted Mr Skerritt by presuming the advertising's audience can understand whether or not they are the 'intended audience'.
It could be argued the TGA is even making the case for a form of US-style direct-to-consumer advertising because it appears to believe an 'intended audience' can understand the content is for them. The implication is that the advertising will raise awareness of treatment options amongst the intended audience. Surely, that is a positive outcome?
A logical extension of the regulator's statement is that the 'unintended audience' would probably understand the content is not for them. That said, even if the advertising reaches the 'unintended audience', the regulator is saying it is fine as long as it assesses the impact as low. Yet based on what criteria?
Is the decision that the law simply does not apply here?
The TGA's statement on the resources published by the Targeted Therapies Alliance clearly conflicts with the laws it administers, its own statements and actions, and might reveal an awkward reluctance to apply the law to NPS MedicineWise given the implications and the fact it might significantly expose the failure to do so for over two decades.
It seems the TGA has simply decided the laws on the advertising of prescription medicines do not apply in this case. It has determined the issued resources are not advertising despite clearly meeting the legal criteria. The regulator's previous decisions very clearly indicate the resources are advertising.
This issue is exposed by two very simply questions.
How would the regulator respond if a company with a PBS-listed bDMARD issued a media release with links to websites containing publicly available and branded resources on this class of medicines? How would the regulator respond if the resources explicitly targeted patients and did not delineate between forms of disease or mention alternative reimbursed medicines?
These are rhetorical questions because the response would be clear and justified.
A wider issue might be the fact companies with PBS-listed prescription medicines do not advertise their brands directly to patients, not least because it is prohibited by their own internal compliance rules and the Medicines Australia Code of Conduct.
Has the TGA considered the issue in the context of such an overt and brash example of brand advertising as seen in the resources published by the Targeted Therapies Alliance?
This alliance is no different to a biopharmaceutical company because its very existence is based on a commercial imperative. It is linked to a budgeted savings measure and its members are all being paid. The notion a government-funded initiative has a legal pass based on a level of 'intent purity' is utter nonsene. On the contrary, by its own rules governmnent-funded campaigns must set the highest standard. Yet what we have is a double standard that is giving this campaign a pass.
This issue needs to be urgently addressed by the regulator to protect the integrity of its own administration of this incredibly important area of law. Confidence in regulators relies on their consistent application of regulation.
Why not just authorise the campaign? If not, then it needs to cease with the appropriate sanctions.
What is the law?
The Therapeutic Goods Act 1989 (Act) makes it unlawful to disseminate (advertise) "by any means" information on prescription medicine to the Australian public, with significant punishment for those found in breach of the law.
In addition, according to the TGA, "If the public or health professional considers that the information promotes the use or supply of the identified goods, then we would consider it an advertisement."
Yet the law does allow for advertising as long as it is authorised by the regulator. The Act's 'restricted representation' requirement applies where something is considered advertising.
According to the TGA website, "Therapeutic goods advertisements to consumers must not refer to a serious form of a disease, condition, ailment or defect (as defined in the Therapeutic Goods Advertising Code (the Code) unless authorised by the TGA."
It says, "If an advertiser wants to use a restricted representation in advertising therapeutic goods to consumers but there is no existing approval or permission, they must seek approval by submitting an application for approval to the TGA."
The TGA authorises exemptions to this requirement through individual legislative instruments. They are not unusual, with around 250 granted over the past 20 years.
There is a very low bar for something to be considered a "serious form of a disease, condition, ailment or defect" given the regulator has authorised advertisements for over-the-counter pharmacy medicines, dietary supplements and nicotine vaping products.
Inflammatory bowel diseases like Crohn’s and ulcerative colitis clearly meet the legal definition of "serious form of a disease, condition, ailment or defect" but the regulator has not made any authorisation that would make the materials published by the Targeted Therapies Alliance lawful.
The TGA argues it is unnecessary because it does not believe the materials meet the definition of advertising. It thinks the intended audience would understand they are designed for them and that, even if they are accessed by the 'unintended audience', the impact is low.
What are the criteria for the TGA forming this view given it has issued so many authorisations for over-the-counter medicines, dietary supplements and even nicotine vaping?
Clearly, smokers wanting to quit know they are the intended audience for nicotine vaping products in the same way a person suffering pain knows they are the intended audience for the advertising of over-the-counter painkillers. The impact on non-smokers viewing advertising for nicotine vaping products would be low so why the need for an authorisation?
Why the need for authorisations in all these other cases but not where a government-funded organisation is publicly promoting some brands of PBS-listed medicines for inflammatory bowel disease while ignoring the existence of others?
