What You Should Know About Licensed Products

licensed versus unlicensed products

I was born right just when the drug thalidomide was being prescribed for morning sickness. This has always made me feel particular empathy towards those people who were born with defects caused by that drug. I have run into a few of them over the years, and of course they are always about my age so it makes it very easy to imagine what my life would have been like had the luck of the draw turned out slightly differently.

The problem with thalidomide is that the molecule exists in two forms which are nearly identical. One is the mirror image of the other. Only one of the forms causes the problem, and the originally testing was done on the other. Tragically, over time the good form slowly transforms into the harmful one. This made the problem very hard to unravel and around the world tens of thousands of unborn babies were killed and some were born with serious deformities.

This was the case that triggered the introduction of serious drug licensing around the world. Nowadays if you want to launch a drug you have to submit a serious amount of data on the work you have done to government regulators. This is examined in great detail and if it does not meet the standards your license will not be granted.

On the whole the system works well, and there has been no repeat of a medical disaster on the scale of the thalidomide tragedy. But nothing is ever perfect. The licensing of pharmaceuticals is a time consuming and expensive business which has to be recouped by the high price of drugs. It also makes it almost impossible to launch a new drug unless you happen to be one of the big drug companies, so it certainly works to stifle innovation and reduce competition. But I think most people would accept that this is a price worth paying for safe medical treatments.

The interesting area is the borderline between drugs and cosmetics. There are skin conditions that are clearly medical. Leprosy for instance is obviously a disease. But how about acne? Severe acne is a disfiguring condition that makes its sufferer’s life a misery. I’d say that was a disease as well and that powerful drugs are justified. And those drugs need to be controlled in the same way as any others. But at the other end of the scale, someone with some unpleasant but not too serious spots on their skin might well want to buy something a lot milder. And it would be a bit of a waste of money if they could only buy expensive drugs.

In fact when you go to the chemists/pharmacy/drugstore you’ll find that you have quite a lot of options. The thing to remember is that in nearly every country the products that count as drugs are regulated in a very different way to the ones that are considered straight cosmetics. In the UK the best way to spot the difference is to look for the product license number. For example the product license number for E45 Cream is PL 00063/0404. The license only allows certain claims to be made for the product, so even though E45 is a drug the people who make can’t claim it would cure skin cancer for example. The packaging is also approved, which tends to make licensed products look a bit dull on the shelf compared to the cosmetic products.

It is worth bearing in mind that the licensed products will have had a lot more work done on them and that the claims that they make have been scrutinised a lot more strictly than the straight cosmetic products.

References

This is the Medicines and Healthcare Regulatory Agency’s own summary of the drug licensing process in the UK.

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/index.htm

The FDA’s website is bit busier, but this page looks like a good place to start for the US.  But the essential system is pretty much the same worldwide.

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/default.htm

4 thoughts on “What You Should Know About Licensed Products

  1. Ali

    Speaking of leprosy, isn’t thalidimide an effective treatment for that disease? I seem to recall reading about that somewhere.

  2. Colin Post author

    Yes, thalidomide is still used as a treatment for leprosy. The production is done very discretely. I once visited a plant where they were making it and only found out by chance that they were doing so. I don’t know how the clinicians use it, but I imagine they only prescribe it for people who aren’t pregnant.

  3. Antonia

    I used to work in a hospital pharmacy and I recall that men had to sign something to say that they were using contraception whilst taking thalidomide and women who were taking it had to have regular pregnancy tests.

  4. RubyHeat

    This reminds me of my hypersomnia. Studies have already proven flumazenil but it still has go through a ton of approval before it can be put on the market for hypersomnia sufferers. Its going to be a long wait. 🙁 I think they should make an exception for this one and just help us.

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