The TGA Review - Our Response

• Advertising therapeutic goods
• Orphan drugs
• TGO48 compliance
• Exports
• Stakeholder input
• Food/Therapeutic product interface
• Conclusion

IT is now three months since the Government responded to the TGA review - a response which provided a blue print for change across a number of key areas of the Administration. Implementing the changes outlined in the response is one of the our highest priorities.

In this article, TGA News provides readers with an up-date on implementation, reflecting some of the consultation processes underway, and many of the key timeframes for action.

Advertising therapeutic goods

A recommendation from the TGA review was that the Department of Health and Family Services should take up administration of the Therapeutic Goods Advertising Code (TGAC), following the demise of the Media Council of Australia (MCA). The Government, taking into account the past efforts, called for industry to increase its involvement in advertising matters by adopting the role proposed for the Department. The Proprietary Medicines Association of Australia (PMAA) and Nutritional Foods Association of Australia (NFAA) worked hard to meet this challenge.

In early July, those efforts paid off when the Australian Competition and Consumer Commission (ACCC) granted a four year authorisation, under the Trade Practices Act, to the PMAA/NFAA collegiate for administration of the TGAC. It is important to note that, for the first time, direct sellers and marketers will be involved in the administration of the Code. This is a key step towards implementing the Government's call for these groups to be brought within the TGA consultative process.

Another encouraging development is the involvement of the Direct Sellers Association of Australia (DSAA) and Australian Direct Marketers Association (ADMA) in the NFAA's Code Administration Committee and Complaints Resolution Committee. The input of these groups and their commitment to compliance with codes governing advertising will fill a significant gap in this area.

On the pre-clearance front, developments over the past month are well worth noting. While the PMAA has done an excellent job with broadcast pre-clearance over a number of years, the demise of the MCA created a gap in the area of print pre-clearance. Discussions between the office of the Parliamentary Secretary for Health and Family Services, the PMAA, NFAA and the TGA resulted in agreement that, in future, the NFAA will pre-clear material relating to complementary medicines with PMAA responsible for pre-clearance of other print advertisements.

PMAA will also continue to pre-clear all broadcast advertising. While mechanisms for ensuring consistent application of the TGAC have been agreed, there are a number of key issues still to be resolved.

Top of page

Orphan drugs

Implementation of the new orphan drugs program is progressing well with the TGA and the US Office of Orphan Products Development working on the exchange of information between agencies. The APMA, Orphan Australia and others are providing valuable input on key issues such as defining an orphan drug (including population groups and size), and principles for accepting and evaluating an application for an orphan drug.

Another key issue under consideration is the process for determining and handling drugs designated as 'orphan' in Australia, but not in the US. Given the rate of progress to date, the TGA hopes that further major announcements on this new program will be made in August.

TGO - 48 Compliance

A reminder that, as of 1 July 1997, full compliance with TGO-48 has been required. There is only one exception to the 1 July 1997 timeframe: sugars. The requirement to notify sugar content is exempt for a period of 6 months, until December 1997.

Exports

The Government response to the TGA review indicated that "there is further potential to examine Australia's export arrangement, to remove unnecessary regulatory obstacles while still maintaining appropriate standards for Australian products and meeting national and international public health commitments". The Government response asked the Department of Health and Family Services to work with industry to develop further options for positive and practical change in the exports area.

Mr Tom Hayes AO, of Tom Hayes and Associates, has been contracted to undertake this further review on behalf of the TGA. The consultants will report to the TGA in late August.

Consultation with stakeholders is integral to Mr Hayes' consideration of issues. Initial discussions have been held with the APMA, PMAA and NFAA as well as a number of companies involved in exports. Relevant submissions to the TGA review and the Industry Commission inquiry into the pharmaceutical industry are also being reviewed.

Stakeholder input

One of the key actions arising from the Government response was finding a way to involve consumers in ADEC and MEC evaluation processes.

The TGA, Consumers Health Forum, APMAand PMAA have made significant progress with implementing this initiative. The Terms of Reference for a feasibility study have been agreed, and an appropriate organisation will shortly be contracted to undertake this work. The feasibility study will report on processes for consumer involvement which will ensure that company confidentiality is protected.

Food/Therapeutic product interface

To enable extensive consultation with members, the NFAA has sought an extension of the deadline for the review of definitions at the interface. The Office of the Parliamentary Secretary has agreed that the TGA can report in September, rather than July.

Readers should be aware that, in granting this extension, the Parliamentary Secretary noted that it may not be possible to introduce legislative changes in the Spring sitting of Parliament, as originally intended.

Conclusion

As well as providing an update on the progress with implementation of the Government response to the TGA review, this article highlights the timeframes that we are working to.

Your input on any issue would be welcomed. As many of the timeframes are tight, we would appreciate it if youwould flag your intentions as soon as possible.

New Parliamentary Secretary

Hon. Trish Worth, MP

The TGA has a new Parliamentary Secretary The Hon. Trish Worth, MP. See the next edition of TGA News <http://www.tga.gov.au/docs/html/tganews/news25/tganews25.htm> for full details.

Top of page

STOP PRESS: Action on royal jelly

Both TGA and The Australia New Zealand Food Authority (ANZFA) will again review the safety of products containing royal jelly because of the continuing implications of royal jelly in severe adverse reactions.

TGA sent a letter on 2 July to all sponsors of products containing royal jelly entered on the Australian Register of Therapeutic Goods, requesting safety and efficacy information under section 31 of the TGA Act 1989. Evidence on safety and efficacy will be considered by the Complementary Medicines Evaluation Committee at its inaugural meeting. This committee will advise the TGA on appropriate action.

In the meantime, containers of royal jelly and royal jelly products, including those currently on the market, must carry a stronger warning of at least 3 mm in height. This warning reads "This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers". Sponsors have been given 60 days to comply with this condition.