The TGA will be initiating targeted compliance reviews for listed medicines that have indications relating to blood glucose or cholesterol biomarkers.

If you are a consumer, there is no immediate concern in taking listed medicines (often known as complementary medicines) that make indications relating to blood glucose or cholesterol. If you have a health condition relating to your blood glucose or cholesterol, you should always discuss this with your healthcare professional first.

Background

We have gathered and analysed data from the compliance review activities of listed medicines conducted in 2015. When comparing indications found to be unsupported by the evidence provided by sponsors, the highest proportion were biomarker indications relating to:
•blood glucose; and
•cholesterol

Those indications related to the:
•management;
•control;
•maintenance; and/or
•balance

of normal, healthy or improved blood glucose or cholesterol:
•levels;
•ratios; and/or
•ranges

Sponsors were often unable to demonstrate that their evidence supported the indications they made above. We endeavour to closely engage with data and research. As such, we will use the data we have gathered to initiate targeted compliance reviews for listed medicines that are more likely to have compliance breaches.

I am a sponsor, what should I do?

If you are a sponsor of a listed medicine containing indications relating to the biomarkers mentioned above, you are encouraged to:
•re-evaluate the evidence you currently hold; and
•reconsider the indications made for your medicines.

You can make changes to the listing of an affected medicine via TGA Business Services(link is external).

Please refer to the Listed medicines application and submission user guide for guidance on this process.

Any changes to your medicine's entry on the Australian Register of Therapeutic Goods (ARTG) must also be reflected on the medicine's label and any advertising material.

What will the TGA do?

We will conduct compliance reviews of listed medicines on the ARTG that have a statistically higher possibility of having non-compliance issues. This activity will start from August 2016. If a medicine is found to be non-compliant, the medicine's entry may be cancelled from the ARTG.

A summary of the outcomes from this compliance activity will be published in due course.

Case study: Blood glucose indications - What evidence is required?

The following indications are similar to those indications found to be unsupported by the evidence that was provided by sponsors:
1.'may help maintain normal blood glucose levels within the normal range in healthy individuals'
2.'may assist in the maintenance of healthy glycaemic controls in healthy people'
3.'supports the control of healthy blood sugar balance in healthy individuals'

What evidence is likely to sufficiently support these indications?

Biomarker indications inherently require evidence with quantifiable data. As biomarkers such as blood glucose do not remain at constant values, the evidence must show how those values are maintained and prevented from going outside the healthy/normal range.

As such, biomarker indications almost always require evidence from high quality scientific sources (primary evidence). These include peer reviewed original clinical research in well cited journals, systematic reviews and unpublished studies where relevant.

Indications 1-3 relate to the maintenance or control of normal healthy blood glucose levels. The Australian Medicines Handbook and Royal Australian College of Pathologists specify the reference ranges for normal glucose levels (at 95% confidence limits in healthy adults):

Other

glucose
fasting: 3-5.4 mmol/L
random: 3-7.7 mmol/L

The primary evidence should quantifiably show that normal healthy blood glucose levels are maintained or controlled in healthy humans.

For example, evidence that would likely support indications 1-3 would be from a clinical study that is:
•double blinded;
•randomised;
•placebo controlled; and
•sufficiently powered;

demonstrating that normal blood glucose levels (fasting 3-5.4 mmol/L and/or random 3-7.7 mmol/L) were maintained or controlled in healthy individuals when compared with placebo.

The Evidence Guidelines outlines the requirements for scientific indications such as those listed above.

What evidence is unlikely to sufficiently support these indications?

If the evidence does not quantifiably show how normal healthy blood glucose (fasting 3-5.4 mmol/L and/or random 3-7.7 mmol/L) is maintained or controlled in a healthy human population, then the evidence is unlikely to support indications 1-3.

In the absence of sufficient primary evidence, secondary sources of evidence, for example those from:
•reference texts;
•websites;
•databases;
•monographs; and
•descriptive studies;

are unlikely to support indications 1-3. Secondary sources of evidence primarily deal with providing an overview of published literature without undertaking a critical analysis. Whilst they do include references to clinical studies, it is not always clear how the literature quoted was chosen or if the assertions or quotes represent the balance of scientific literature. For this reason, they can only provide additional support to primary sources of evidence.

General evidence that refers to the Recommended Daily Allowance (RDA), Adequate Intake (AI) or Recommended Daily Intake (RDI) for an active ingredient does not sufficiently support indications relating to the maintenance or control of normal healthy blood glucose levels, especially in the context of healthy individuals. Healthy individuals would be consuming a normal healthy diet and would therefore already be meeting the RDA, AI or RDI for that particular ingredient. It is unlikely that the medicine would have any different effect than if a normal healthy diet was followed by normal healthy individuals.

http://www.tga.gov.au/listed-medicines-blood-glucose-and-cholesterol-indications