Crawford explained the trend to attendees of the Drug Information Association this fall: "But after a study of this problem,
our agency identified as the major shortcoming the lack of scientific insight that are essential for translating an experimental
substance into a safe and effective healthcare product. This is the crucial issue. In the FDA's view, the state of the applied
sciences that are used for medical product development lags behind the striking advances in the basic sciences that can make
medical breakthroughs possible. As a result, the drug development process is obscured by uncertainties that frequently culminate
in unexpected obstacles and project failures — failures that could be avoided if the obstacles could be foreseen at the start
of the development process."
What is lacking are predictive tools "including assays, standards, computer modeling techniques, biomarkers and validated
surrogate endpoints for use in clinical trials — that would enable sponsors to separate promising candidates from probable
failures early in development," he adds.
The report calls for sophisticated development tools in product safety (animal toxicology and clinical trials), efficacy and
the product's potential for viable large-scale manufacture.
This agenda "will be developed with a lot of external help from the academic and research communities," Crawford explains.
"We also want people within FDA to have ownership in it," he says.
He successfully used the same principles at USDA's FSIS when he advanced the food safety regulatory tool HAACP. Developing
ownership is key to its future success, Crawford adds. When HAACP was originally on the drafting boards, his special assistant
immediately pulled together a 30-person team and sub-teams. Of the 10,000 people at FSIS, close to 1,000 people were in the
planning and drafting stages.
That's what Crawford means by ownership. He left FSIS by the time HAACP received the recognition currently bestowed as a regulatory
There was a time in the 1980s, Crawford recalls, that saw far fewer products making their way through FDA to market.
"One year, we saw no new veterinary and only four human new molecular entities. If there was a person with a rare disease
that could later be treated with some pharmaceutical or an animal population that need special therapy, they could forget
it in the United States. It was a period of time that FDA was very conservative and afraid of being too cozy with the industry."
In 1993, human medicine adopted user fees as a mechanism to spur drug approvals. Congress has approved similar legislation
for FDA's Center for Veterinary Medicine, dubbed the Animal Drug User Fee Act (ADUFA), which ultimately will allow CVM to
hire 60 new people to review drugs.
Crawford says he originally was opposed to user fees because he thought they might be a conflict of interest, but he's a believer
now. The concept gets money into FDA for specific review.
He says it also allows the agency to prepare for new chemicals coming through the research and development pipeline.
"We used to hear things about a new generation of antibiotics coming. But we didn't dare ask industry because that would be
a conflict of interest. So we hung around here with the same old tired collection of personnel; there are too few of us and
(we're) too inexperienced. And then along came this whole new set of drugs that we were not ready for, nor did we have expertise
in. Now we sort of know what is coming, and we can plan for it. I think ADUFA and its descendants have been very good for
FDA and good for the country."
Day in the life
So what's a typical day like for an FDA commissioner?
Count on morning meetings with key staff to cover the day's agenda. Assignments are handed out, and the day's agenda is set.
Many more meetings ensue. In fact, he says that half of any given day's meeting are internal, half external. He gives about
one speech a day at some function. He does about 300 a year. He maintains two offices: one in Rockville, Md., and one near
Capitol Hill. He is in both offices almost every day.