What I find most amazing about this story is this quote from Christopher Viehbacher, president of North American pharmaceuticals for Glaxo. Says Viehbacher “…it is harder to get approval for variations of drugs because the FDA now demands to know why they are better than the original.”
Well excuse me, Chris – what do think the FDA should do?
A well known tactic that companies like Glaxo undertake in order to maximise revenue from best selling drugs about to go out of patent is this: they simply create a slightly different version of the drug and start to market the ‘new, improved’ version. Maybe it’s simply a slow release version, or maybe it has a few different molecules. Whatever, the important thing is that it must be able to be patented once again.
And now the FDA is spoiling the party by having the cheek to ask Glaxo to prove the new versions of drugs are better than the old versions… the truth is they’re better for the drug companies because they make yet more money for them.
Here’s the story from This is Money:
The strategy of GlaxoSmithKline to extend sales of its biggest-selling drugs is under threat from the US Food and Drug Administration, critics of the agency say.
The FDA is accused of posing new questions to Glaxo as it re-submits previously approved drugs.
Nomura analyst Mike Ward, said: ‘The whole industry is finding it difficult because the FDA is understaffed, and focusing on things they think are more innovative and important.’
The agency approved Glaxo’s Parkinson’s disease treatment Requip XL, a modified version of the older drug Requip, at the weekend. But delays mean a generic version is already on the market.
Christopher Viehbacher, president of North American pharmaceuticals for Glaxo, said it is harder to get approval for variations of drugs because the FDA now demands to know why they are better than the original.