SCRIPPS PRESIDENT CHARLES EDWARDS MAY RETURN TO FDA AS "INTERIM" HEAD; HARD-NOSED MANAGEMENT, TOP REPUTATION COULD HELP FDA THRU TOUGH TIMES

Former FDA Commissioner and Assistant Secretary for Health Charles Edwards, MD, may be asked back to head FDA when the current commissioner, Frank Young, MD, departs in mid-December. Edwards has already been back to Washington to discuss the possibility of his return to government with key Capitol Hill figures, including Sen. Hatch (R-Utah), the current FDA kingmaker. By the end of the week of Nov. 13-17, Washington FDA watchers were recovering from the initial excitement of Edwards' visit and were predicting that he would reject the offer. Associates of Edwards, however, indicate that he is still considering the offer seriously. For the past 12 years, Edwards has headed a staff of 1,262 employees at the Scripps Clinic and Research Foundation, a leading immunology research center in La Jolla, California. He went to Scripps in 1977 after two years with Becton Dickinson. From his top research institute job, he has remained intimately involved with the leading areas of drug and biotechnology research but has not developed any significant commercial conflicts of interest. Edwards does sit on at least four boards of firms with dealings with FDA. An Edwards appointment would be a classic example of the knight-in-shining-armor strategy for refurbishing a government agency's public and political image -- similar to the second tenure of William Ruckleshaus at the Environmental Protection Agency in the middle of this decade. Edwards' potential appointment is being described as "interim" or "temporary"; however, based on the longevity of most FDA commissioners, that seems like a fine distinction. At HHS, Secretary Sullivan, Assistant Secretary for Health James Mason, and Assistant Secretary for Legislation Gerald Olson have been meeting to consider the personnel shifts. White House health policy advisors have disavowed direct involvement in the Young reassignment. Even if Edwards is not the ultimate choice to replace Young, just the effort to get him back to Washington indicates some of the key attributes being sought in the next commissioner. Topmost on that list are the combination of Washington experience (with particular emphasis on legislative negotiations) and proven management skills. Two of the other people being mentioned in relation to the FDA job also have those skills: FDA Acting Deputy Commissioner James Benson and D.C. attorney Robert Pinco (Baker & Hostetler). Both are FDA veterans and are familiar with legislative issues. Edwards also has the reputation in scientific circles and the medical degree which are always definite plusses for the FDA top post. Legislative savvy: The next commissioner is likely to face several significant legislative efforts arising from ongoing oversight hearings: increased FDA authority in the generic drugs review area; medical device amendments; and possible food and health claims legislation. A new commissioner already familiar with FDA authority and the checks and balances between FDA's explicit and implicit powers would have a much better chance of succeeding in those negotiations than a neophyte to FD&C law. The long-term threat from the current round of Capitol Hill hearings is a series of legislative changes fashioned in a crisis atmosphere. Some Capitol Hill staffers, in fact, were initially dismayed by the announcement that Young was leaving FDA. The Hill staffers were looking forward to working with Young on amendments to give FDA more retaliatory authority against suspected cheaters in the regulatory system (see related story, p. 9). They felt that Young had become so close to the generic review scandals that he would be an open advocate of increased FDA authority. A new commissioner will almost certainly take a cooler, dispassionate approach to amendments. Management and organization skills: The agency's self-image has been damaged by the generic investigations and the personnel shifts associated with them. For example, the wrangling between FDA's general counsel staff and the HHS Inspector General's office over authority in FDA matters has had a depressing effect on FDA's sense of autonomy. During his four years at FDA, Edwards was described as a hard-nosed manager. He oversaw a wholesale turnover of top managers and the recruitment of a long list of new staff. Among the prominent figures still involved in the health area who went to FDA under Edwards' tutelage were Richard Crout (VP, Boehringer Mannheim), Sherwin Gardner (VP-science & technology, Grocery Manufacturers of America), Peter Hutt (Covington & Burling), Mark Novitch (exec VP, Upjohn), Jack Walden (senior VP-public affairs, Nonprescription Drug Manaufacturers Association). Edwards also worked closely with Upjohn Chairman Theodore Cooper, who succeeded Edwards as assistant secretary for health in 1975. Those connections could facilitate an Edwards return, but they also raise the potential criticism of cronyism since many of his previous colleagues are now in positions representing regulated industries. In an ironic history-repeats-itself situation, 20 years ago, Edwards stepped in for a commissioner (Herbert Ley) who was bedeviled by a series of adverse news stories. Like Young, Ley was also offered a deputy assistant secretary's position. Ley declined the job (see box, p. 8). On Capitol Hill, Edwards will be known mostly by reputation. His tenure at FDA and HHS predates most of the current figures in health (Waxman, for example, was only a freshman congressman when Edwards was in the last year of his stay in Washington). However, Edwards was involved (from the department topside) in the HHS struggles with Sen. Kennedy over the investigations of industry-bias at FDA and in the launching of the MAC (Maximum Allowable Cost) reimbursement regs. Edwards could assume the position as a recess appointment without having to go through confirmation before the Senate Labor & Human Resources Committee, where Sen. Kennedy is still a force to be reckoned with. According to new legislation, the FDA position requires Senate confirmation. "CAN HISTORY REPEAT ITSELF?": EDWARDS' FDA APPOINTMENT DEC. 10, 1969 The following are excerpts from coverage by the Dec. 15, 1969 issue of "The Pink Sheet" of the first appointment of Charles Edwards to head FDA in late 1969. Edwards was chosen by HEW to replace FDA Commissioner Herbert Ley, who was offered a position as deputy assistant secretary for health. Ley declined the position. The situation, the rationale for a change in commissioners, and the comments on the future prospects for FDA are uncannily similar between mid-December 1969 and mid-November 1989. In deference to how little Washington changes, and in the spirit of appreciating coincidences, "The Pink Sheet" is highlighting some of the comments on Edwards and the change in command at FDA 20 years ago. COM. EDWARDS IS MANAGEMENT-ORIENTED, TO STRESS EFFICIENCY, NOT COP-ISM; DESPITE AMA BACKGROUND, WON'T BE "PATSY"; MAKES FIRST DECISION, ON OCs FDA's new commissioner, Dr. Charles Edwards, is a management-oriented former surgeon who will try to turn FDA into a more efficient agency that handles its business more rapidly. His regime is expected to de-emphasize the "cop" aspect and stress a businesslike organizational approach to handling regulatory and product clearance problems. "My first job is to evaluate what's there, and to fill in the voids," Edwards told "The Pink Sheet." He added that he is "sort of numbed by what I've got to do in the next couple of months." At this stage, Edwards said, he is far from ready to fix FDA priorities, or to decide on filling the many key vacancies. While some of them will be filled from within -- where he finds some "terribly able people" -- many are likely to go to new faces. Edwards' approach to his job was pointed up at HEW's [the Department of Health, Education & Welfare] Dec. 10 press conference announcing the FDA shakeup. After a questioner asked Edwards what attributes he would bring to the commissionership that are not already there -- and [HEW Assistant Secretary for Health Roger] Egeberg muttered that Edwards "is a hard-nosed son-of-a-bitch" -- the new FDA chief picked up on the phrase. Describing what he was going to do with FDA, Edwards said: "We are going to bring into FDA some hard-nosed management principles and . . . where needed some hard-nosed managers, and hopefully some . . . capable scientists." Edwards handled deftly the skepticism of reporters whose questions indicated a basic distrust of a former AMA official in a regulatory agency such as FDA. "Do you see your primary responsibility to the doctors and drug makers or to the people who use doctors and drugs and use pesticides?" he was asked. "I think the responsibility of the commissioner of FDA is to the consumer," Edwards answered. "I think by the same token he has to be reasonable however with the providers of health care and . . . pharmaceutical manufacturers." Egeberg said Edwards was brought into the department "because he is a good administrator, and God knows we need a lot of people with administrative ability in the medical sphere in HEW." But when reporters started to zero in on Edwards' philosophy towards industry, Egeberg said "he isn't . . . quite ready to answer some of the questions you put to him." Commissioner Ley's statement on departing FDA on Dec. 11, 1969 "Congresses follow Congresses enacting new consumer protection legislation but failing to appropriate the funds to do the job. Congressional committees follow Congressional committees criticizing FDA for not doing what they think it should be doing, but failing to enact stronger legislation. . . A new Commissioner and another reorganization of FDA are not the only solutions. The real solution is to isolate FDA functions from political pressures; to give the agency the resources to do its job; and to provide the kind of national leadership and support that will allow any Commissioner to act responsively and responsibly, solely in the public interest." CHARLES C. EDWARDS -- CAREER-AT-A-GLANCE EXPERIENCE 1977-present: President and CEO, Trustee, Scripps Clinic and Research Foundation 1975-1977: Senior Vice President, Becton Dickinson 1973-1975: Assistant Secretary for Health, HEW 1969-1973: Commissioner, Food and Drug Administration, HEW 1967-1969: Vice President, Managing Officer, Health and Scientific Division, Booz, Allen & Hamilton 1963-1967: Director, Division of Socio-Economic Activities, AMA 1961-1962: Council on Medical Education and Hospitals, AMA 1961-1962: Instructor in Surgery, Georgetown University Medical School EDUCATION 1941-1943: Princeton University 1945: University of Colorado, BA 1948: University of Colorado, MD 1956: University of Minnesota, MS Surgery 1950-1956: Surgical Fellowship, Mayo Foundation, Rochester, Minn. HONORS Distinguished Alumnus Award, Mayo Foundation, 1986 Distinguished Fellow, Toxicology Forum, 1985 American Hospital Association, Honorary Membership Award, 1975 Distinguished Service Award, U.S. Dept. of Health, Education and Welfare, 1975 Honorary Degrees, Florida Southern College; Philadelphia College of Pharmacy and Science; Pennsylvania College of Podiatry CURRENT MEMBERSHIPS & PROFESSIONAL AFFILIATIONS Member of the Board of Directors: Bergen Brunswig Corporation; Biomagnetic Technologies, Inc.; Coordinated HealthCare Systems; Hospital Corporation of America, Inc.; Nova Pharmaceutical; Molecular Biosystems, Inc.; San Diego Chamber of Commerce Consultant, GAO Health Advisory Committee National Leadership Commission on Health Care Diplomat, American Board of Surgery Fellow, American College of Physician Executives Fellow, American College of Surgeons Member, AMA; Institute of Medicine; New York Clinical Society; Society of Medical Administrators