After almost non-stop claptrap about there being too many new drugs comes a sobering fact: even as pharmaceutical companies poured a record $43 billion into research and development in 2006, U.S. Food and Drug Administration statistics show that the agency approved only 18 new drugs last year. That's down from 36 in 2004 and nearly as low as it's been at any time during the past decade.

According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."

Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"

The FDA's Critical Path Initiative is the agency's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or proof of concept into a medical product.

When Thomas Edison was asked why he was so successful he responded, "Because I fail so much faster than everyone else." Think about the millions of dollars that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process. Biomarkers are measurable characteristics in animals or humans that can help predict the performance of a product during development, reducing uncertainties about safety or effectiveness.

Currently, 50 percent of drugs that undergo large-scale late stage trials turn out to be too unsafe or not effective enough for marketing. That is not a sustainable model for the 21st century.

Consider the implications if the FDA could help companies to fail faster. Using the lower end of the $800 million cost estimate from the Tufts Center for the Study of Drug Development for bringing a drug from discovery to market, a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs. Shifting just 5 percent of clinical failures from late stage clinical trials to early stage trails reduces out of pocket costs by $15-$20 million.

Change the Mission
As the agency enters its second hundred years, that mission must change to both protect and advance the public health. And in order to do that, the agency that regulates upwards of 25 percent of the U.S. economy needs new tools, new expertise and more funding.

As with any large family there is internal bickering. But when the family is attacked, the wagons are circled. That is the circumstance today. And it is impossible to accept advice (even good advice) from people viewed as "enemies of the agency."

The public controversies and revolving leadership in recent years at the FDA has created an agency that, instead of searching for ways to be more relevant in the 21st century, is scrambling for quick-fix solutions, responding to ad hoc attacks from politicians and pundits with clumsy measures that, in many cases, are based on the Precautionary Principle—the very antithesis of a science-driven FDA. And that certainly is change—dangerous change.

It's time for the FDA to replace that with a more positive, future-oriented and science-based vision that allows the agency to move down "the critical path" more directly and rapidly to both protect and advance the public health.

There is no question that without core scientific expertise and capacity, it will be difficult to identify problems in product development across products and disciplines, to identify the real critical path opportunities, and to help set priorities. A healthy and sustainable vision would include appropriate support of cooperative agreements, partnerships, targeted infrastructure in specific areas, and joint training programs.

Science Should Govern
As FDA's bioinformatics and biomarker capability increases, its scientific abilities will be strengthened by being deeply and consistently engaged in collaborative drug evaluation development work. We must use the mantra of the agency's current antagonists that FDA must be governed by science not politics and use it to our advantage by creating a roadmap for scientific development that is the gold standard for how evaluation should be conducted.

I recently had the privilege of a private meeting with Nobel Laureate Joshua Lederberg. The topic of conversation was the future of the FDA and the agency's Critical Path initiative. We talked about the state of applied research and "the texture" of the agency, the prioritization of development science, biomarkers and a host of other future-oriented issues. He talked. I took a lot of notes. At the end of the meeting he put everything into perspective in a single sentence. He leaned over the table and said, "The real question should be, is innovation feasible?"

I hope so.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.

The Journal of Life Sciences welcomes commentaries. To submit a piece, contact Daniel S. Levine at daniel.levine@blsmg.com or 415-591-5449.