FDA BLUE RIBBON PANEL CHAIRMAN EXPECTED TO BE CHARLES EDWARDS: FDA’s BENSON PREDICTED TO REMAIN COMMISSIONER THROUGHOUT BUSH PRESIDENCY

Executive Summary

Scripps Clinic President and former FDA Commissioner Charles Edwards, MD, is expected to be named in the next few days to head HHS Secretary Sullivan's blue ribbon commission to chart the agency's future course. Delivering a keynote address at the Industrial Biotechnology Association's annual investment community conference Feb. 23, Senate Labor & Human Resources Committee Minority Health Policy Director Nancy Taylor said Edwards appointment to chairman of the panel would be announced as early as "this weekend," with the remainder of the commission to be named shortly thereafter. The appointment of Edwards to chair the panel appears to end several months' delay in assembling the commission. Edwards has headed the Scripps Clinic since 1977. He served as senior vice president of Becton Dickinson the previous two years. Edwards' appointment to the panel has been anticipated since last fall, when he rejected an offer to return to FDA as commissioner ("The Pink Sheet" Nov. 27, p. 3). He headed FDA during the Nixon Administration and from 1973 to 1975 was assistant secretary for health of what was then HEW. Taylor, who is Sen. Hatch's (R-Utah) chief health care advisor on the committee, said Hatch is planning to meet with Edwards on Feb. 27, if his appointment is announced by then, to urge the commission to ask the White House to double FDA's budget. IBA President Dick Godown, in his opening remarks at the two-day conference in Ft. Lauderdale, Florida, strongly praised the idea of a blue ribbon panel and supported the idea of boosting FDA resources. "This blue ribbon panel, once it gets rolling, could have a great deal to do with convincing White House political operatives that an addition to the staff and budget at FDA is not simply an addition to the government bureaucracy," Godown said, adding: "That attitude should have left with the last administration." Godown also named other possible members of the commission. In addition to Edwards, he said, the "names one hears mentioned most often" as likely to be appointed to the commission are Tufts University's Louis Lasagna, chairman of FDA's eponymous Lasagna Commission; Rita Colewell, who heads the biotechnology center at the University of Maryland and David Kessler of the Albert Einstein School of Medicine and a former Hatch staffer. Godown also predicted that a CEO from a biotech company would sit on the panel. Taylor's comments on the blue ribbon panel apparently were in response to comments made the day before by former FDA Chief Counsel Thomas Scarlett. In a presentation to IBA on the regulatory "rules of the game," he was deeply pessimistic about HHS Secretary Sullivan's chances of getting the panel off the ground. Scarlett said his pessimism was based on reported White House opposition to the blue ribbon panel concept and Sullivan's failure to go through proper channels. Scarlett left FDA abruptly last summer after HHS delegated to the Inspector General enforcement authority for felonious violations of the FD&C Act. He is now a partner with the D.C. law firm Hyman, Phelps & McNamara. "Sullivan apparently came up with the idea [for the blue ribbon commission]...in the latter part of last year and, as far as anybody can tell, didn't fly it past the White House," the former FDAer remarked, noting that is "one of the problems." Another difficulty, according to Scarlett, is that when the White House saw the proposal and saw who was being recommended for the panel, "my guess is that they concluded that if this panel were actually put into place and made a recommendation, the recommendation that they would most likely make would be to double up FDA's budget. If you're [Office of Management & Budget Director Richard] Darman or one of his munchkins and you see that," Scarlett said: "you immediately do what OMB always does: you sit on it." While disagreeing about the blue ribbon panel, Taylor and Scarlett concurred that a successor to former FDA Commissioner Frank Young is not likely to be named during the remaining three years of President Bush's Administration. In response to a question from the audience on the chances for a new commissioner being named soon, Scarlett said: "I don't think during this administration." He predicted that Acting Commissioner James Benson will continue to occupy that position for the foreseeable future, at least "for the next several years." Taylor concurred that Benson will most likely remain. "It will be very difficult to fill that position for a while," she said, noting that a commissioner-designate would, for the first time, face the congressional confirmation process voted into law during the 100th Congress under a bill introduced by Sen. Gore (D-Tenn.). Additionally, delays would come from the FBI and White House security clearance checks, which take "three to five months" and by the fact that the current short session of Congress is slated to end Oct. 5. Speculating on who might make an acceptable candidate, she said: "Dr. [Charles] Edwards has some very strong opinions on who should be FDA commissioner. He believes, and that's one of the missions of his advisory panel...it should probably be someone who...understands industry and who has a working experience of management, rather than an academician."