Exclusive: Documents reveal regulator's 'cover-up' of unlawful advertising

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Is there a blatant and indefensible double-standard at the heart of the TGA's regulation of advertising with punitive action against some organisations while others get protection?

The regulator's handling of the resources released by the Targeted Therapies Alliance could be described as a 'cover up'.

Is this one part of the Department of Health acting to protect and give special treatment to a budgeted savings initiative funded by another part of the Department of Health?

The alliance published resources on 16 June with branded information on PBS-listed medicines.

On 18 June, BioPharmaDispatch published a story stating the resources meet the definition of 'advertising' and, as such, are unlawful in the absence of authorisation. There is no authorisation.

Documents obtained through Freedom of Information (FOI) show the TGA agreed that aspects of the resources meet the legal definition of advertising. It went further and even advised NPS MedicineWise of this fact.

They just decided to withhold this important information in their responses to questions on the issue.

The TGA went through the process, reviewed the resources and appears to have mostly come to the right conclusion. Unfortunately, it then decided on a cover-up.

This decision came despite one mid-level official twice including reference to the TGA's recognition of the resources as advertising in draft responses to questions from BioPharmaDispatch. These references were removed by senior officials.

What do the documents reveal - the first response

The first draft response to questions said some elements of the resources "are likely to meet the legislative definition of ‘advertise’ in relation to therapeutic goods".

That means the resources are almost certainly unlawful.

It also said, "In line with its risk-based regulatory approach, the TGA has provided information of an educational nature to NPS MedicineWise in relation to the promotional elements of the material."

Unfortunately, these admissions were removed from the final statement sent to this publication.

What do the documents reveal - the second response

Did the TGA make a decision to deliberately mislead in its public response to this issue?

It appears so because the mid-level official tried again in their draft response to a set of follow-up questions from BioPharmaDispatch.

The draft once again included the statement, "The TGA has reviewed the materials and determined some elements of it are likely to meet the legislative definition of ‘advertise’ in relation to therapeutic goods."

However, and once again, a senior official removed the statement in the final response sent to BioPharmaDispatch.

NPS MedicineWise was told to change the TTA's approach

The documents obtained through FOI confirm the TGA provided advice to NPS MedicineWise on "the promotional elements of the material".

In this case, the word 'promotion' means advertising, which is unlawful.

We can infer the nature of the advice given the most recent resources released by the Targeted Therapies Alliance - on non-bDMARD treatments for plaque psoriasis - do not include brand names.

The alliance has the sole purpose of delivering a budgeted savings measure. It is led by an organisation that was found in the government's own review to have misused its taxpayer-funded grant to fund a commercial venture.

Yet for some reason, it seems to enjoy the enduring protection of the Department of Health to the extent the 'independent' regulator appears to be giving it a 'pass' on the unlawful advertising of prescription medicines, quietly giving it advice, and then withholding this information in public statements on the matter. The decision to withhold this information makes the public statements misleading.

A blatant and indefensible double-standard

In the past, the TGA has been punitive in its application of the advertising laws. It has levied significant fines against individual pharmaceutical and biotechnology companies and even promoted the penalties on social media platforms.

Yet when it comes to a government-funded initiative and organisation, the response was to obfuscate, mislead in its response to questions and, in doing so, engage in what has the appearance of being an indefensible cover-up of unlawful conduct.

How can stakeholders have confidence in the consistent application of regulation when there is clearly inconsistent treatment of stakeholders?

What would happen to a company?

The regulator has publicly argued it chose not to consider the branded resources published by the Targeted Therapies Alliance as advertising because they are broadly consistent with clinical guidelines.

This claim makes no sense and contradicts what it actually did.

In private, it said elements of the resources are advertising and communicated that to NPS MedicineWise and the Targeted Therapies Alliance, which probably explains the changes in its most recent publications on plaque psoriasis.

Would the TGA take the same approach to resources published by a pharmaceutical or biotechnology company?

Are we expected to believe the regulator would quietly allow a company to change resources and then effectively deny that in public statements?

Who is the regulator really protecting?

Is the TGA simply protecting a government-funded savings initiative? Or, is the issue a reluctance to acknowledge its own failings over many years?

NPS MedicineWise has been publishing branded resources related to PBS-listed medicines for around two decades. Much of what it has published may have met the "legislative definition of ‘advertise’ in relation to therapeutic goods" making it unlawful in the absence of a TGA authorisation.

Was the regulator's public response to the Targeted Therapies Alliance actually about not wanting to admit its long-term failure to properly regulate the organisation's activities?

Regardless, it should be embarrassed by its lack of transparency and decision to withhold information, the conflict between its public and private statements, and what looks like a decision to give special treatment to one government-funded initiative.