Fudging the numbers?

And when the numbers are anything Wall Street might have an inkling of an interest in, really strange things have been known to happen.

By Editor on Feb 22, 2006

And when the numbers are anything Wall Street might have an inkling of an interest in, really strange things have been known to happen.

According to new analysis in the February issue of the RPM Report, a new monthly publication focused on prescription drug regulation and policy, the number of novel drug approvals by the US Food and Drug Administration in 2005 was the lowest in more than two decades.

By the FDA's count, it approved 20 new molecular entities (NMEs) in 2005, which the RPM Report calls a lackluster showing at best. But using a metric the group calls Innovative Commercial Therapies (ICTs), it finds the FDA approved an even more disappointing 16 novel drugs in 2005.

The RPM Report defines ICTs as genuinely novel molecules. The classification does not consider single isomers, prodrugs, metabolites, follow-on biologics, imaging agents and biowarfare/counter-terrorism agents in its counts.

The RPM Report says the FDA approved 28 ICTs in 2004 and 26 in 2003.

Senior executives from drug companies are putting a good face on the number of approvals and say they anticipate a long-term turnaround beginning in 2006, the groups says. But it adds: The FDA itself is less optimistic, saying a turn-around could be 5 years away.

Like all other industries, of course, pharma is a glass half full group when it comes to painting a picture from the numbers, especially when it's one that Wall Street is looking at closely. No one should be surprised by that.

And there's nothing really wrong with that as long as we don'st go around with a paper bag over our heads about the reality of the situation - which, again, we doubt few are.

And that's where the good news from the RPM Report analysis comes in. According to the group, there is no debate on the reasons for the drought in NMEs, ICTs or whatever name you prefer to put to the industry's new therapies.

Both companies and agency officials point to the lack of new submissions from companies rather than slowdowns among regulators as the cause of the drought, the group says.

So whether you call them apples or oranges and whether you tally 16 or 20, what's painfully clear is the industry needs more of them. But we knew that already. And, we'sre sure you won'st be surprised when we tell you that Wall Street did, too.