1. Jay on May 11, 2010 1:57 PM writes...

Benzyl alcohol for head lice? I presume as a topical application... maybe this will be the new advertising campaign?

http://www.theonion.com/articles/johnson-johnson-introduces-nothing-but-tears-shamp,2506/

2. The Pharmacoepidemiologist on May 11, 2010 2:46 PM writes...

At one time, an EU-US comparison was a fair one. No longer. The tolerance for risk in the EU is much better these days than in the US. I'm not talking law suits either (though the EU may trump the US in that regard too). US FDA has essentially been told by Congress that it's safety over everything else. Have you tried getting a meeting with FDA lately? It's a far longer wait than PDUFA requires, and if you protest to the agency, you get hit with the response of "Go cry to Congress and see if we care." Some of this focus on safety over all else is the public's response to some of the screwiest marketing efforts the industry came up with. So it's no surprising. But given that bent in the US (and it's been taking hold for several years now), I don't think that one can fairly compare EU approvals with US ones. The playing fields are just too different.

3. biotech investment paradigm on May 11, 2010 5:25 PM writes...

I can agree with #2. IND's are usually submitted to the EU first, with a seemingly more "accepting" agency. I'd expect the approval gap (time between the EU and US) to continue to widen as the FDA's requirements become more and more stringent.

4. Wilks on May 11, 2010 6:28 PM writes...

If you hadn't had enough of hating Pfizer, here's another reason (#456).

More layoffs...

http://www.nytimes.com/2010/05/11/nyregion/11pfizer.html?scp=2&sq=pfizer&st=cse

5. MTK on May 11, 2010 10:23 PM writes...

Derek,

Sounds like time for a Venn diagram!

6. Still Scared of Dinosaurs on May 12, 2010 6:59 AM writes...

Not sure # of INDs is the right measure. My experience is that Phase 1 is very easy to start in England but that has little bearing on which side of the Atlantic the development focuses on.

That focus is often crucial. FDA worships placebo control and EMEA is openly hostile to it, and I worked on one drug for which giving each agency what it wanted was practically impossible. So, natch'ly, we followed the path to us approval, but this was a while ago.

I often think a sponsor would be better off developing sister molecules in parallel tailored to the two approaches. Probably a good strategy except for that whole cost thing.

7. ChemNerd on May 12, 2010 8:42 AM writes...

Derek, I notice that you do quite a bit of hyperlinking to Wikipedia such as in this blog post. I'm curious what you think of Wikipedia and the quality of its articles in the the chemistry/pharmacology field. Presumably your linking means that you find the article quality sufficient for this type of use, but what about for more serious work-related use? Is it useful, accurate, or thorough enough for a research scientist? Do you contribute to Wikipedia yourself, or know of any colleagues that do? (Perhaps a blog post soon, I humbly suggest.)

8. Dylane on May 12, 2010 12:30 PM writes...

So the overlap that does occur though is concentrated in the biologic space. It looks like there are 4 biologics that were approved in both the EU and US in 2009, out of 9 total for the US? If I'm reading that right that is, I don't have access to the Nature article, so I'm working back a bit from your list.

9. Regulatory in UK on May 13, 2010 1:39 AM writes...

Re Still Scared of Dinosaurs, first of all, many of the EU guidelines actually [i]recommend{/i] placebo control in their clinical trials, so it all depends very much on a)the indication and b)the country. Even in countries which are traditionally hostile to placebo control, providing a good justification for its use, even referencing FDA guidelines is often successful.

Also, the IND system is particular to the FDA (and other systems modelled on it, e.g. Korea, Philippines, especially since it renamed its RA the FDA - obviously didn't think to check if that name was already taken!) so literally comparing them isn't realistic when comparing Europe.

Finally just to point out: England and the UK aren't interchangeable terms - England is one part of the UK, as are Scotland, Wales and Northern Ireland and members of the latter three don't appreciate being labelled as "England". The MHRA serves the UK, not just England.

10. Regulatory in UK on May 13, 2010 1:40 AM writes...

Re Still Scared of Dinosaurs, first of all, many of the EU guidelines actually [i]recommend[/i] placebo control in their clinical trials, so it all depends very much on a)the indication and b)the country. Even in countries which are traditionally hostile to placebo control, providing a good justification for its use, even referencing FDA guidelines is often successful.

Also, the IND system is particular to the FDA (and other systems modelled on it, e.g. Korea, Philippines, especially since it renamed its RA the FDA - obviously didn't think to check if that name was already taken!) so literally comparing them isn't realistic when comparing Europe.

Finally just to point out: England and the UK aren't interchangeable terms - England is one part of the UK, as are Scotland, Wales and Northern Ireland and members of the latter three don't appreciate being labelled as "England". The MHRA serves the UK, not just England.

11. petros on May 14, 2010 7:32 AM writes...

Some interesting points but its better to remember that NDAs and MAAs are frequently not filed concurrently, which hinders such analysis.

But a recent case highlights the discrepancy.
n 2009 Nycomed filed for approval of the PDE4 inhibitor rofluimilast for the treatment of COPD (a major, and poorly treated, disease). In April 2010 the CHMP recommended approval of the MAA but the same month the FDA's advisory panel voted 10-5 against approval citing insufficient evidence of efficacy.

12. Still Scared of Dinosaurs on May 14, 2010 9:05 AM writes...

R in UK - I am aware that the UK and England are not interchangeable but from my experience it seems like all Phase 1 work outside the US is done at Guy's so maybe my focus was too broad.

And, yeah, you can do active control in US and placebo in Europe (can I include the UK in Europe in this context?) but the default is pretty much as I stated. My core point was that outsiders don't have much of a clue as to how many decisions we make along the way that constitute compromises between optimal EMEA versus FDA strategy...and sometimes the rest of the world gets into the mix as well. Looking at approval rates without knowing what strategic decisions were made - knowing that the tendency has been to tilt towards US approval - doesn't generate a meaningful comparison, IMHO.