The TGA's first Direction under the new regulatory regime for advertising of therapeutic goods shows how it will respond (and how quickly).
Close to three months after the introduction of the amendments to the Therapeutic Goods Act 1989 (Cth), which introduced a new regulatory regime for advertising of therapeutic goods, the Therapeutic Goods Administration (TGA) has published its first Direction under the new section 42DV of the Act. The Direction indicates that the TGA will respond swiftly when it finds advertisements for therapeutic goods to be in breach of the Act or Therapeutic Goods Advertising Code ‒ and expect sponsors to do the same.
Section 42 of the Act ‒ Direction about advertising to consumers
On 27 September 2018, the TGA published its first Direction (dated 7 September 2018) under section 42DV of the Act about advertising of a therapeutic good to consumers. Section 42DV was added to the Act as part of the most recent legislative reforms in relation to therapeutic goods (the majority of which came into effect on 1 July 2018). It empowers the TGA to issue a direction requiring a person to take certain types of action in relation to an advertisement for therapeutic goods.
The first section 42DV Direction is published on the TGA website and details the:
- corrective action to be taken by the person apparently responsible for the advertising (or for causing the advertising) of the therapeutic goods;
- conditions applied to the Direction, such as the timeframe within which the corrective action must be taken (in this case, within 7 days of the date of the Direction) and when evidence of compliance must be provided to the TGA;
- reasons for making the Direction (including material findings of fact (including the complaint made), what action had been taken by the TGA as at the date of the Direction and an assessment of advertising compliance) and the effect of the Direction; and
- a summary of the "Advertising Complaint Outcome", including the compliance status, key dates (such as when the complaint was received, when it was actioned and the outcome date) and a list of identified offences/breaches.
Although not publicly available, the other attachments said to be included with the Direction address the possible consequences of failing to comply with it, those sections of the Act relevant to the decision to issue the Direction and review rights in relation to the decision (as an initial decision under the Act).
Personal website and Facebook links to the relevant advertisements have been redacted from the published version of the Direction. However, by virtue of the social media platforms identified in the Direction, the responsible person's name and the name of the relevant product, the firm was able to obtain access to the non-compliant advertisements. Presumably there is a desire to keep the public from accessing or viewing the non-compliant advertising and this may require some further consideration.
A swift push for compliance
The publication of the Direction is in accordance with sub-section 42DV(6) of the Act, which requires the Secretary of the Department of Health to publish the Direction on the Department’s website "as soon as practicable" after issuing it. In this instance, the proposed publication date was included in the Direction ‒ being three days after the date of the Direction. Although it was ultimately published 20 days after the Direction date, it was a quick turnaround by the TGA.
These steps reflect the purpose of the recent legislative reforms in relation to advertising of therapeutic goods, being to more effectively deter inappropriate and misleading advertising and enhance compliance by therapeutic goods sponsors in Australia.
The TGA's "Advertising Hub"
Section 42DV Directions are accessible through the TGA's "Advertising Hub". The more recently established online forum collates educational and training material on advertising of therapeutic goods, guidance for advertisers of therapeutic goods in Australia and information on sanctions, penalties and the regulator's approach to advertising complaints handling.
The "Advertising Hub" was launched alongside the introduction of the recent legislative reforms in the therapeutic goods advertising space.
Key lessons for therapeutic goods sponsors
Two important lessons for sponsors of therapeutic goods to take away from this Direction are, first, the importance of maintaining a strong internal compliance protocol to ensure any representation to consumers complies with the Act and the Code, and second, it will be equally important to have a clear protocol for responding to any complaints, or Directions from the TGA, in a timely manner and in accordance with the timeline outlined in the Direction.