In minutes from a December meeting of the Therapeutic Goods Agency – Australia’s medicines regulatory body – attendees discussed criteria for drug products making weight loss claims.
They acknowledged scientific criteria being considered may push some products making claims as weight loss drugs would struggle to do so under new guidelines that may deliver a stricter interpretation of usable scientific backing for claims.
A TGA officer at the meeting expressed concern, “that the introduction of the Guidelines would push some products into the ‘food domain’ as they would be unable to meet the criteria for evidence as outlined in the Guidelines.”
He added the issue would be addressed as part of the implementation process of the guidance document entitled: ‘Draft Guidelines for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss’.
The draft guideline, released for public comment in February 2009, was developed because the TGA received a number of complaints in relation to “creative advertising claims” made for weight loss products.
The guidance highlighted several issues including:
- a lack of guidance regarding traditional evidence
- inconsistencies between the guidance and previous TGA guidance on the issue
- clinical trials criteria
- proposed labelling changes
- implementation of the guidelines.
The discussions and response to the guideline revealed a polarisation of the industry between those that backed a liberal system that permitted many claims and those that advocated ever-tighter controls.
One of the main points raised hinged on how products that make claims in relation to appetite suppression or increased metabolism would be affected by the guidelines.
One TGA member raised the issue of study population relevance. The guidelines state: “Studies used to justify indications relating to weight loss must be conducted in populations that are socioculturally representative of the general Australian population”.
“This was a standard that would be difficult to achieve,” the member said, amid a discussion about how, say, trials conducted on Asian populations could be extrapolated to the Australian population.
This led to members agreeing to an amended statement: “Studies used to justify indications relating to weight loss should be conducted in populations that are reasonably representative of the general Australian population.”
It is expected implementation of the guideline will take between six months and five years.