Drug development is back in the news and, as you might expect, the news is not good. A Government Accountability Office report to Congress released in November looked at drug development expenditures over a 10-year period ending in 2004 and found that the well-publicized increases in research and development costs—often fingered by pharmaceutical manufacturers for the monumental increases in drug prices—are not producing commensurate increases in new drugs. Based on the measures used by the GAO, greater expense plus reduced output can only lead to one outcome: productivity is down and getting worse.

What's to blame? No simple answers there, nor shortage of candidates: An overemphasis on developing blockbuster drugs. A reliance on producing "me too" line extensions that protect patents at the expense of truly innovative products. Lack of consensus about standards for measuring the effectiveness of drugs. The shortage of clinician/ scientists (yet another consequence of that endangered species' slide into oblivion) who can bridge the gap between drug discovery and clinical application. The lack of an organized, coordinated effort to analyze why specific trials fail.

Some of the productivity shortcomings, the report suggests, may be cyclical. For example, companies have invested heavily in new technologies that will take time to produce a measurable impact on new drug applications.

We're not going to legislate our way out of this problem, but here's something for our brand spanking new Congress to work on when it reconvenes this month (amid dire media predictions of closer scrutiny of big pharma). If you want to get the attention of the for-profit drug companies about improving the drug development process, make it worth their while. In an August article in the New England Journal of Medicine, Dr. Alastair J.J. Wood does so with a four-step proposal that focuses not on the stick, but the carrot.1 It's too much to abstract here, but it is worth a look for its novel emphasis on rewards.

For drug makers, the key is the "period of exclusivity" of a drug, the time during which a patent holder has exclusive right to sell a drug without competition from generic drugs. To entice development of truly novel drugs, Dr. Wood says, offer longer exclusivity. For academia, offer incentives to refocus on the development of clinician/scientist programs to make such a career choice viable once again.

It's time for new thinking about drug development. Dr. Wood's proposal is a start. And the best part—it's the American way. Even a Democrat can get behind that.