It's good to be back. I missed Indiana (though, frankly, the Miami weather could quickly convert me into being a Dolphins fan).
Anyway, this week we learned more about the complexities of the biopharmaceutical business, including the challenging and costly pathway leading to the regulatory approval of new treatments in the United States.
On Monday, media reported on 2010 FDA drug approvals, with reports saying the agency approved 21 medicines over the last 12 months - the lowest number since 2007. And on Wednesday, the Center for the Study of Drug Development at Tufts University released a new analysis saying drug development now costs more than ever - approximately $1.3 billion for a new treatment that reaches the market.
Why the gap? Drug discovery targeting mysterious diseases that have vexed researchers for decades is obviously complex (and a complete analysis would stretch well beyond my liberal arts background). But certainly we can connect some dots back to the environmental hurdles we've talked about in this space. Our CEO, John Lechleiter, has spoken to multiple audieces, including the World Health Congress, about a three-pronged strategy to accelerate biopharmaceutical innovation. Those pathways include:
- The industry changing its approach to innovation.
- Risk/benefit assessments during the drug approval process.
- Policies that allow innovation to thrive.
Here's the good news: wheels are turning on these fronts. Lilly has taken a unique approach to research and development that includes a variety of partner relationships. Benefit and risk are expected to be discussion points when the renewal of PDUFA heats up over the next two years. And we've seen signals that government leaders are interested in preserving innovation - for instance, the biosimilars language in the health care reform law.
The benefit/risk analysis is an intriguing one. As Dr. Lechleiter said last year at the World Health Forum, the problem lies not with the regulators, but within the system itself. There are many incentives to avoid risk, and a potential medicine that's not approved will not expose that risk. But even with the inherent risks of this business, we cannot lose site of finding treatments that may save, or vastly improve, millions of lives.