Medical Device Daily Washington Editor

WASHINGTON The FDLI/FDA conference could not pass without some discussion of the January report from the FDA's Science Board which offered a comprehensive itemization of what are alleged to be the agency's various deficiencies and failings.

At first, this seemed like little more than a rehash of earlier discussions (Medical Device Daily, Jan. 30, 2008), but when it came to specifics especially the leadership ability of the agency's chief, Andrew von Eschenbach the kid gloves came off, the boxing gloves put on.

On the second day of the meeting, Gail Cassell, PhD, VP for scientific affairs at Eli Lilly (Indianapolis, Indiana) and chair of the Science Board, said the board's effort "was the first time that this agency was reviewed as an entire agency" with one other exception.

"Our overall conclusion is that science at the agency is in a precarious position ... and demands on the agency have soared but resources have not," Cassell said.

She said that FDA "is not able to meet its regulatory demands," adding: "The thing that I find most disturbing about these findings" is that the resource crunch "has resulted in serious scientific gaps." She said the drain has left the agency in a "firefighting posture versus a proactive posture" and as a result, is "unable to keep up with major scientific advances."

Cassell then tried to soften the blow a bit. She said the board "felt very strongly about FDA's staff" and that the report "is not intended to reflect badly on FDA's staff."

Also on the dais was Peter Hutt, former chief counsel for FDA, now is a partner in the DC law firm of Covington & Burling.

Hutt disagreed with at least one of Cassell's statements, saying that the Science Board review "is actually the fourth time FDA has been reviewed as an institution." He said "the first three reports were in 1955, 1962 and 1991" and that all three were commissioned by department secretaries (in the case of the first two, the Department of Health, Education and Welfare).

"The impact of those reports was tremendous," Hutt said, with the 1955 report spurring a budget increase of 144% in four years. He said he could document every statute affecting FDA from 1897 on," but "if you cut it off at just the last 20 years, there have been more than 120 statutes that order FDA to do one thing or another.

"That's six a year, and none of them call for one cent for implementation," Hutt said, adding that the agency has doubled the number of ports where FDA inspectors reside, from 45 to 90, but there are more than 300 ports in the U.S.

Sidney Wolfe of Public Citizen (Washington), a vociferous critic of FDA, asserted that recent reports of FDA scientists feeling pressured to change their views on product applications demonstrate that "the user fee is the wrong way to go" and cited "the laziness on the part of Congress that is bespoken by user fees."

Wolfe said the reticence of agency executives to make a public case for more money is "not acceptable anymore." And he described von Eschenbach as the source of "terrible leadership possibly the worst leadership I've ever seen in 35 years.

"There was really better leadership in the old days," he said.

Pressed for details concerning von Eschenbach's defeiciencies, Wolfe described him as a "very pleasant person," but that he had "appalled" the staff at the National Cancer Institute by telling them that their No. 1 job is to do what the executive branch wants.

"I don't think he's that intelligent, I don't think he's a very good scientist," Wolfe said, adding that the position calls for "someone who does not run away from problems."

Hutt took a plainly different tack. He said that the validity of those criticisms "in part depends on your philosophy of what is the function of" an appointee.

Hutt acknowledged that Congress asked von Eschenbach how much money FDA needs, "but as anyone knows ... he's not the only commissioner who has done that. Every commissioner has defended the president's budget," Hutt concluded.

Wolfe responded that von Eschenbach could at least "make the case privately."

Hutt replied, "he has done so. You can't say that [about the budget] publicly, but he has done so."

Hutt went on to discuss a series of scientific deficiencies in the early 1970s, which he said later, as circumstances developed, were "shown to be far over-stated, far over-blown."

"You're always going to find some disgruntled people," he said, "and those are the ones you quote" in discussions of employees reporting pressure to clear products. "You're not quoting the vast majority of FDA."

(At this point, several members of the audience applauded, not the only time [and it should be noted that a substantial portion of the attendance was from the agency]).

Carl Peck, MD, a former FDAer, came from the audience to say "I was flabbergasted at Sid's comments."

"I've read [the Science Board] report and discussed it with several of the parties on the panel. I agree with some" of the findings," he said, "I don't agree that there are far too many statutes" or "that the morale has waxed or waned."

"What I think is not correct is that there is a profound deficiency in the science," he said. He said that that in past eras he could "confirm that the science was good at that time," and that "there is good science being practiced now," though he acknowledged "pressures we didn't have at [that] time."

Peck finished by rebuking Cassell for her remarks about the agency's purported talent gap, saying, "I think it's a disservice to say the science is profoundly deficient, and I think you owe FDAers an apology."

Cassell attempted to soften her tone, saying her criticisms were "more a lack of specific scientific capabilities, not that the individuals who are there are deficient."