Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all.
So far this year, FDA has approved 20 new molecular entities (NMEs), according to The Wall Street Journal. That’s nearly the same number of NMEs that the agency approved throughout all of 2010. “We’re seeing a lot of innovation, much more than in recent memory,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told The Wall Street Journal. She went as far as to say that the industry had reached a “turning point” in drug development.
The change in the industry’s approach to research seems to be helping to enhance its development productivity. Many companies have shifted from an expensive, and potentially wasteful, “mass production” approach to one that relies on collaboration. Bristol-Myers Squibb’s (BMS) recently approved melanoma drug was originally discovered by a scientist at the University of California, Berkeley. The scientist worked with small biotech company Medarex to develop the drug, which eventually appeared on BMS’s radar. After BMS and Medarex formed a partnership, the rest was history. Shire also has used this collaborative strategy successfully.
Woodcock’s comments reaffirm my belief in the industry’s ability to market innovative drugs that improve patients’ lives. If the pace of NME approvals continues at its current level, it will soften the blow of the patent cliff for many companies. Maybe reports of Big Pharma’s impending death are greatly exaggerated.