Magazine
Another Year, Another Dolor?
All apologies to Adolor Corp. and William H. Gass
By Gil Y. Roth
One of my college pals works in IT for a top five pharma company. Every quarter, he has to travel to the corporate HQ for training. On his most recent visit, he had a conversation with the company's IT chief. The exec asked him what facility he was from, and when my pal told him, the exec replied, "Hmm. That's funny."
"Why's that?" my pal asked.
"Well, [facility x] isn't on the list," the chief said.
"What . . . list?"
"The list of sites we still plan on operating by 2010," he was told.
". . . Oh. That list."
While it's refreshing to learn that -- no matter how high they ascend in the corporate hierarchy -- IT guys never quite get a handle on social niceties, it's scary to think of the number of plant closings and sell-offs in the years ahead.
In the final months of 2007, we received more restructuring notices and lowered financial guidances from major companies that, only a few years earlier, were touted as Companies of the Year in various publications. (In case you've ever wondered why our Top Companies report is only based on financial rankings and don't include a "Company of the Year," it's because no one stays on top for too long in this industry.)
And with the end of the year, we learned that FDA approvals of new molecular entities reached a 25-year low. Or, as In Vivo Blog put it, "That's 25 years ago, folks. Gandhi won best picture. Toto won album of the year. A Philadelphia sports team actually won a championship." Ouch.
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Electioneering
It's hard for me to believe that this is the third Presidential election year in Contract Pharma's history. It's even harder for me to believe that we have another nine months of this crap to put up with. As I write this, Obama was celebrated as the Democratic front-runner and next incarnation of JFK after ekeing out a win in Iowa's non-voting primary. Several days later, Hillary Clinton was celebrated for having staged a 2004 Red Sox-level comeback in New Hampshire. On the GOP side, Iowa's results led to the conclusion that America would become a theocracy, only to be trumped days later in NH by the conclusion that Americans are happy about Iraq. This constant need by the media to treat every moment as, well, momentous, is enough to drive alprazolam sales through the roof! --GYR
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Naturally, this result has led to a flurry of finger-pointing. Some industry figures feel that the FDA has become too cautious, post-Vioxx. A Bloomberg article on the subject quotes GlaxoSmithKline CEO Jean-Pierre Garnier's analyst call last October, "The hurdle has been raised, there is no question about it. We are working on 25 launches over the next three years. Some of them will be delayed that probably wouldn't have been delayed if we had those 25 products even two years ago."
In response, Janet Woodcock, FDA's deputy commissioner, said, "Our standards for what constitutes a safe, effective drug have not changed. But our ability to analyze data for potential safety problems has improved, and we're especially vigilant when we're evaluating drugs for chronic conditions -- drugs that people will be taking daily for many years."
It's tough to say that she's exactly refuting Mr. Garnier's point, so much as elaborating on it. Still, it doesn't bode well for new approvals, especially since, as the In Vivo bloggers point out, the next three worse years for NME approvals occurred this decade.
So, in the spirit of the new year, here's hoping that past performance is not indicative of future results, that you have a great 2008 (personally and professionally), and that your facility stays on The List!
