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Submissions received and high level summary: Boxed Warning guidance

Related information

29 November 2018

Submissions received: Boxed Warning guidance consultation

The TGA would like to thank respondents who provided submissions in response to the August 2018 public consultation paper, Consultation: Boxed Warning guidance.

A total of 29 submissions were received. Of those submissions, 13 were from industry and regulatory consultants, 1 from an industry representative group, 4 from individuals, 4 from health professional groups, 6 from consumer and other affiliated groups, and 1 from an independent statutory authority.

All submissions that gave permission to be published on the TGA website are now available below in PDF format. An additional 4 of the received submissions have claims to confidentiality or privacy that prevent the publication of submission, and/or identity.

TGA response

The TGA, along with other international medicine regulators, has in place Boxed Warnings as a risk mitigation measure to highlight special warning statements in the Product Information (PI) to the prescriber. In Australia, these warnings are intended to provide information about a real or potential concern that has a major impact on public health by the occurrence of serious adverse events or interactions. More than 30 products on the Australian Register of Therapeutic Goods currently have a Boxed Warning.

For a number of years, no formal guidance has been provided to industry or the public on the use of Boxed Warnings in Australia. The TGA sought feedback from interested parties on proposed Boxed Warning guidance in August 2018. The draft guidance was intended to assist sponsors in when a boxed warning may be required for their products and prescribers and consumers to understand the rationale for why the boxed warning had been included. The guidance also increases transparency on the process for the public. It should be noted that the new guidance largely captures an existing requirement and processes.

Feedback from the 29 submissions was considered. The concept of a Boxed Warning received strong and consistent support from all stakeholders. The manner in which it should be used was subject to mixed views. The guidance has been revised and additional measures have been included to incorporate stakeholder feedback. Key areas of concern or interest for stakeholders were:

  • Evidence required to implement a boxed warning
  • How and when a Boxed Warning is required in the PI
  • How and when a Boxed Warning is required in the CMI
  • Incorporation of Boxed Warnings into promotional or commercial material
  • Prospective versus retrospective implementation
  • Mechanism of further stakeholder engagement

Next steps

The requirements will be fully effective with publication of the guidance. Not all feedback could be incorporated on the basis of mixed stakeholder views. To allow opportunity for all key stakeholder groups (industry, prescribers, consumers and TGA) to gain experience with the guidance, the guidance is proposed to be re-assessed in 18 months to determine if any additional information is required.

The need for further information to be provided to the public was identified and comments from consumer affiliated stakeholders will be fed into ongoing TGA-consumer education, communication and engagement initiatives.

Outcome summary

Summary of changes resulting from public consultation: Boxed Warning guidance
Item Current situation Proposed changes Benefits

Boxed warning guidance in place

No guidance on boxed warnings is available to sponsors or the public.

Publication of revised guidance incorporating consultation feedback where there was general agreement across all stakeholder groups.

Increases transparency regarding the process and requirements for a boxed warning.

When a boxed warning is proposed

A Boxed Warning is a mechanism used to highlight special warning statements in the Product Information (PI) to the prescriber. These warnings typically concern a real or potential for major impact on public health by serious adverse events or interactions with other medicines and require a specific warning due to the severity of the event.

No change to current approach.

Ensures that a boxed warning remains one of the most severe warning statements that the TGA imposes. Boxed warnings are not used in isolation and sit alongside a range of other risk mitigation measures used for prescription medicines. The Boxed warning is in addition to the warning and precaution section of the product information and is intended to be used sparingly, so as not to dilute the severe warning impact of the statement.

Publication of new boxed warnings safety alerts on the website

In the past, the TGA has usually published a safety alert when a boxed warning has been added to a product already available in Australia. Boxed warnings for new products have not been included under safety alerts on the TGA website. It is proposed that any product with a boxed warning is published as a safety alert on the TGA website.

Introduces a consistent approach to the publication of boxed warnings for all prescription medicines available in Australia.

Ensures transparency when a boxed warning is put in place at any time in its life-cycle.

Boxed warning in the CMI

The Therapeutic Goods Regulations 1990 (Schedule 12) currently require the Consumer Medicine Information (CMI) to be consistent with the PI.

If a Boxed Warning is required in the PI, then similar prominent information should be provided to the consumer.

It is proposed that a Boxed Warning should be placed at the beginning of the CMI, in a manner that provides sufficient information for a lay consumer to understand the risks or to prompt a conversation with their healthcare professional.

This introduces consistency to the format in which boxed warnings are presented in the CMI and consistency for consumers in knowing when there are specific risks in certain populations with the use of the product.

Provides warning and information in the CMI that is actionable and addressed to the patient.

Promotional material

Whereas advertising prescription medicines to consumers is not permitted under the Therapeutic Goods Act 1989 (the Act), advertising to health professionals is permitted within the scope of the legislation and is regulated by a self-regulatory scheme operated by Medicines Australia.

No change to the current approach.

For prescription medicine products that have a boxed warning included in their PI, all promotional material must include the boxed warning or a prominent statement drawing attention to the boxed warning.

Ensures prescribers are made aware of a boxed warning as part of product promotion.

Additional communication or education activities

Currently the TGA may require risk minimisation and communication activities alongside the boxed warning including:

  • Patient alert cards
  • Patient education apps, websites and printed materials
  • Healthcare professional education material
  • Dear Healthcare Professional letters

No change to current approach.

Ensures appropriate education of, or communication with, patients and healthcare professionals, and is determined on a case by case basis.

Prospective implementation

The guidance will be implemented prospectively, since boxed warnings have been used by TGA for many years and the new guidance mainly serves to provide greater clarity and transparency on an existing requirement.

Currently there is inconsistent or no advice to industry as to when a boxed warning should be included and where it should be included in the CMI.

The new guidance will maintain current practice but with greater transparency and consistency.

Allows for continuity in the way that boxed warnings are used within the existing risk management framework.


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