A report released yesterday by the Government Accountability Office reports that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.
This is yet another example of the GAO â€œreportingâ€ something that is widely known, widely reported, and widely debated. But itâ€™s worth repeating because it focuses the spotlight on the crucial need for better drug development tools â€“ precisely the remit of the FDAâ€™s Critical Path program.
Please refer to our report, â€œPrescription for Progressâ€ which can be found at http://www.cmpi.org At that link youâ€™ll also find video of the conference we held to discuss the future of drug development, with speakers including FDA Commissioner Andy von Eschenbach and FDA Deputy Commissioner Janet Woodcock.
But, alas, rather than using the GAO report to focus attention on the real issue, politicians are using it to pick up some cheap headlines by bashing Big Pharma.
Consider this comment by Senator Dick Durbin (D, IL), "The findings . . . raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market â€¦ Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs."
Hereâ€™s a fact that you wonâ€™t find under Durbinâ€™s Turban â€“ over the last 50 years the average American lifespan has increased by 10 years â€“ a full decade, due largely to the impact of pharmaceutical research and development.
And the scary part is that 21st drug development is more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome.
But, as far as Senator Durbin is concerned, the beatings will continue until morale improves.
Step One: Give the FDA the tools it needs to help industry expedite 21st century drug development. Far too many drugs fail in Phase III. Thatâ€™s not economically smart or sustainable â€“ and itâ€™s certainly not the best way to advance the public health. The FDA Critical Path program can help industry better understand which investigatory new drugs have the best chance for success â€“ and which ones should be abandoned â€“ far earlier in the process.
When asked why he was so successful, Thomas Edison replied, â€œBecause I fail faster than everyone else.â€