For any Aussie ladies who are interested in the background as to why Utrogestan still isn't available in Australia, you might like to hear about a very interesting phone call I had today.
To give you a bit of a background, for some time now I've been trying to get information out of the Australasian Menopause Society and the Therapeutic Goods Administration. The last email I got from AMS just gave me a very cryptic
“There are sometimes mixed messages so we have not heard yet if there are any developments on this issueâ€, but they gave me the phone number of someone who works for Lawley Pharmaceutics in WA.
The good news is that he is someone who is very interested in hormones in general, and is just as frustrated as we are that Utrogestan isn't available here. The bad news is that, if it is approved at all, it could be at least another 3-5 years away, and the more likely market will be for IVF and not menopause. However, once it is approved, the likelihood that it will also be used for menopause is very high.
What it boils down to is that it is all political, and the Aust Govt has a very long memory. Apparently Australia was one of the first countries to approve the use of thalidomide, and we all know what happened with that. So consequently Australia has now become one of the toughest countries in the world to get new drugs approved in. We are second only to the USA, but the difference is that USA has such a huge population that pharma companies are willing to jump through hoops to do whatever the FDA tells them to do, so they will have access to that huge market.
The TGA in Australia will take absolutely no notice of any other country's approval process or length of use of a medication, so the fact that Utrogestan has been used for decades holds no sway with them at all. They always require the drug company to go back to the drawing board and prove the effectiveness and safety of any medication available here. So, basically because Australia has such a small population, and we have no major pharma companies of our own, we are seen as just being “too much trouble†to bother with. It is starting to dawn on the government that this is not working in our favour, and that we are falling behind with some medications, but the wheels of government always turn very slowly.
New Zealand, on the other hand, has a much smaller population than Australia, but Utrogestan is available there. However, NZ has a much lower standard of medication approval, so that's how that happened.
I suspect that there is very much a double standard going on here though. Viagra, for example, is a relatively new medication (in comparison to Utrogestan) and it is readily available here on prescription. There are also a lot of other newer drugs which are readily available, so how did they get approved so quickly? Estradiol is also readily available here and has been around about as long as Utrogestan has, and would have a similar sized market, so none of it really makes much sense, but we're talking about government decisions here, and they rarely make sense.
Interestingly, Lawley Pharma does import Utrogestan into Australia, but they can only supply it to a small number of doctors who have applied for special approval to prescribe it, and more than likely that will be for IVF. Another piece of good news is that (I think he said) the Marketing Manager at Besin Pharmaceutics is Australian and this guy from Lawley Pharma actually knows him, so he does have a certain amount of influence. However, we are still at the mercy of the TGA.
I asked how the compounding industry is able to supply progesterone, and he said this is just basically a loop hole in the laws because they are importing a raw product for single use only. Should they start mass producing it, they would then come under the same criteria as the pharma companies.
So, at least for the foreseeable future, I will have to continue obtaining my Utrogestan from my online source.
I'm not sure if I'm allowed to post this, but he has a blog about hormones. I haven't really had much time to look at it, but it might provide some interesting information.
http://michaelbuckley.net/ 
