The stakes are enormous.
FDA is estimated at regulating product sales that top $1.7 trillion.
How does Crawford balance the two extremes?
Crawford explains, "Between 2 to 3 percent of all the drugs that FDA approves have to be taken off the market after they are
approved. The public rightfully expects us to be fail-safe. If not fail-safe, then figure out some way of dealing with it."
It's a statistic that has held true for the last 30 years, he adds. "Whatever we do, we do not seem to have gotten control
over that and neither do other western countries.
"The public wants something to happen when one of those drugs are pulled off the market, regardless of how long they have
been on the market or how may people have been injured. They usually believe that we should have acted earlier, or the company
should have acted earlier.
The public wants a very transparent peer-review policy, and they want to understand why FDA is making these decisions," he
Consumers also demand greater access to information on adverse reactions, and the agency has responded by placing a great
deal of information on its Web sites.
Crawford adds that consumers demand risk-management programs to minimize adverse reactions. In the next six months, FDA is
planning an evaluation of these drugs through the help of the National Academy of Sciences.
"We do need an in-depth look by the world's leading scientists in this particular area."
In addition, FDA is conducting "an internal analysis to determine what the situation truly is."
"The 2 to 3 percent is (a statistic) we have testified before Congress many times, but the intricacies of why that is happening
will be new to a lot of people," Crawford says. "We are putting forward an internal paper on that."
What will history say?
Credited with championing Codex Alimentarius and USDA's Hazard Analysis Critical Control Point System (HAACP) for the Food
Safety and Inspection Service, Crawford's vision for FDA is clear.
He wants to create a suite of modernization and enforcement processes that will last for the next 10 to 20 years.
The agenda is to advance good manufacturing practices (GMPs) among pharmaceutical companies and a risk-based approached to
determining drug safety, dubbed the "critical path". Crawford explains this critical path concept is "how to use modern scientific
techniques to get newly discovered drugs, vaccines, medical devices and laboratory tests to the bedside as quickly, expeditiously
and predictably as possible." It is a major agenda item for the acting commissioner.
"It will be a calculus that doesn't look like a Republican or Democrat thing, it is just something that is a source of steady
improvement over time at FDA. I think the critical-path approach will be around for the next 10 to 20 years."
FDA has advanced an agenda of modernizing GMPs for companies that included some fairly hefty fines for companies based on
violations. Crawford says the agency pays particularly close attention to vaccine and medical product GMPs.
"It would be wrong to say I'm the father of any one of them, but during the time I'm here, those are going to be major accomplishments,"
This "critical path" report is a white paper that outlines key problems in review and development of novel drugs, which have
been steadily declining. In the mid-'90s, FDA received 44 new molecular entities overall and 44 new biologic license applications
a year. In the last fiscal year, FDA received 28 submissions for new molecular entities and 20 applications for new biologics.
Of those new molecular entities, typically just a few are targeted to animal health.
This initiative, however, focuses on the decline of new drug development.