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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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July 29, 2011

2011 Drug Approvals Are Up: We Rule, Right?

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Posted by Derek

I've been meaning to comment on this article from the Wall Street Journal - the authors take a look at the drug approval numbers so far this year, and speculate that the industry is turning around.

Well, put me in the "not so fast" category. And I have plenty of company there. Neither Bruce Booth (from the venture capital end), John LaMattina (ex-Pfizer R&D head) nor Matthew Herper at Forbes are buying it either.

One of the biggest problems with the WSJ thesis is that most of these drugs have been in development for longer than the authors seem to think. Bruce Booth's post goes over this in detail, and he's surely correct that these drugs were basically all born in the 1990s. Nothing that's changed in the research labs in the last 5 to 10 years is likely to have significantly affected their course; we're going to have to wait several more years to see any effects. (And even then it's unlikely that we're going to get any unambiguous signals; there are too many variables in play). That, as many people have pointed out over the years, is one of the trickiest parts about drug R&D: the timelines are so long and complex that it's very hard to assign cause and effect to any big changes that you make. If your car only responds to the brake pedal and steering wheel a half hour after you touch them, how can you tell if that fancy new GPS you bought is doing you any good?

Comments (8) + TrackBacks (0) | Category: Drug Development | Drug Industry History | Press Coverage | Regulatory Affairs


1. johnnyboy on July 29, 2011 8:17 AM writes...

Exactly. If you assume that the uptick this year is real and not just part of normal year-to-year variability, then the credit goes to whatever researchers were doing around 1996-2001. I'm very much afraid to know what the number of new approvals will be in 2020...

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2. Rick on July 29, 2011 8:51 AM writes...

I know it isn't fashionable to say this, but how much of this ephemeral uptick is due to changes at the FDA unleashing a temporary backlog? Something similar happened in the 1990s when it was the introduction of PDUFA, unlocking a stable of drugs in-process, not any change in industry productivity, that gave us a blip that disappeared a year later. Of course, that didn't stop PhRMA from stupidly claiming that it was a boost in productivity thanks to their foresightful leadership. Kinda like now.

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3. qetzal on July 29, 2011 9:29 AM writes...

If your car only responds to the brake pedal and steering wheel a half hour after you touch them, how can you tell if that fancy new GPS you bought is doing you any good?

Especially when you change all the settings on the GPS, or toss it out in favor of a different one, every 5 minutes.

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4. Hap on July 29, 2011 12:04 PM writes...

...or when you change drivers every ten minutes, with each one jumping out of the passenger side door carrying some of your gas money.

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5. pete on July 29, 2011 12:50 PM writes...

@5 Hap
..yeah, but maybe at least they left you with a brand new plastic Jesus on the dashboard as part of the last re-org morale-builder session

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6. Nick K on July 30, 2011 9:50 AM writes...

Perhaps this sudden "improvement" in the number of approvals is merely a statistical blip caused by the random clustering of several candidates arriving on the market at the same time.

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7. The Blue Maharaja on July 31, 2011 12:11 PM writes...

Hate to be an optimist, but maybe the Industy's more recent strategies ARE starting to work?

Maybe this has less to do with what R&D was doing 10-15yrs ago and more to do with changes in attitude to in-licensing - away from the'not invented here' mindset.... and a focus on more niche & orphan/less 'blockbuster or bust' products?

I take @5 Rick's point about 1997 and all that, though: let's all hold our breath 'til we see similar numbers being reported next year!

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8. Health Policy Wonk on August 1, 2011 3:35 AM writes...

The ultimate problem here is that even approvals of new agents are nothing more than an intermediate measure. Its how well these new products perform in the marketplace that matters. Unfortunately, we're living in an era of greater and greater pressure on all health care spending--including Rx products. As a result, it is becoming a greater challenge for developers to support new agents with the data packages and contracting strategies needed to assure that all the hard work in R&D turns into revenue for company in question.

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