The rules for FDA officials are strict: Thou shalt not plead for money from Congress. But the rules don’t necessarily apply to Susan Ellenberg, now a professor at the University of Pennsylvania’s medical school. Last week, she told the DIA‘s 22nd Annual Clinical Data Management Conference that the FDA needs more resources. She should know. From 1993-2004, she was the Center for Biologics Evaluation and Research’s director of biostatistics and epidemiology.

Ellenberg didn’t actually beg at all, to be sure. But she was in a position to be candid, and made it clear that inadequate resources from Congress may be one of the reasons Congress itself is frustrated with the FDA. “FDA will never beg for resources to do its job, because FDA is not allowed to beg for resources,” Ellenberg told the audience in Orlando in late March. “An agency whose mission is to promote and protect the health of the public should not have to beg for resources to do its job.”

Much of her talk was devoted to the recent Institute of Medicine report on drug safety; she was one of the authors. “We recognize a number of vulnerabilities in the drug safety system,” she said. “Chronic underfunding—it’s an issue I am going to come back to over and over again.”

Safety Data & Informatics

Besides money, Ellenberg said, there are simple issues of not having necessary data at hand, especially in the post-marketing arena. After drugs have been approved, she said, FDA does not have the facts it needs. Said Ellenberg: “This was a chronic problem, not having access to the kind of data that would help us find new risks as soon as possible. The post-approval process suffers generally from inadequate data and informatics. I don’t think there is anybody who would argue with that.”

She went on to say that not all of the report’s 25 recommendations were directed to FDA. Eight were directed toward the Congress, three toward the National Institutes of Health. In as decorous and dispassionate a manner as possible, Ellenberg hinted that longer tenure in the top job at FDA (a political appointee) could bolster the culture of safety at the agency. “It is disconcerting when you have Commissioners come and go for 12-15 months,” said Ellenberg. One solution in the IOM report: have a fixed, 6-year term for the top FDA position. Even Ellenberg seems to think that may not be a likely shift, given that the White House may change at more frequent intervals.

More Phase IV

Ellenberg reminded the audience that the IOM is proposing that newly approved drugs be tagged with a symbol to alert the public that there may not be a large body of evidence for them. “Not a signal not to use this product, but a signal that we don’t know as much about this product as other products.”

In the question and answer session after her remarks, Ellenberg was asked how the drug safety landscape would be different in five years, after a certain amount of Congressional wind-generation and horse-trading. “I suspect the number of Phase IV studies will go up. Will it grow dramatically? Probably not. I would predict that post-marketing surveillance will become more intense. There will be improved programs to do it.”