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Executive Summary

FDA Commissioner Young has two pending decisions in his four-week lame-duck period at the agency that could solidify his reputation from five years at FDA as the first biotech commissioner of the agency. Both decisions -- one a product approval decision (the Chugai/Upjohn Marogen application) and one a regulation proposal (the orphan drug regs) -- deal with the thorny issue of product differentiation and exclusive license positions in the biotech drug business. The two issues appear ripe and could be a tempting policy legacy for Young away from the generic drug industry and ANDA scandals that have blemished his last year-and-a-half at the agency. HHS announced Nov. 13 that Young will be moving upstairs in the department hierarchy. Effective Dec. 18, Young is being reassigned to a staff position as a deputy assistant secretary for health reporting to Assistant Secretary for Health James Mason. "Dr. Young will provide coordination for the development and utilization of technology," a Nov. 13 press release explains. He will be responsible for coordinating functions of "biotechnology, nutrition and food safety, and for physical science within the Public Health Service." HHS also said that Young will study "technological developments that can be expected to impact on the nation's health care system." When he originally joined the Reagan Administration in July 1984, Young was believed to be interested in an eventual step-up in the HHS hierarchy. However, at the time of the Reagan-Bush transition, Young favored staying in the FDA post for its visibility and public impact. The decision for Young to move was announced one week after the commissioner represented the agency in discussions about European Community approvals. First word of his change in positions was publicized early on Monday, Nov. 13. One of the leading candidates to replace Young in the interim, Scripps Clinic President Charles Edwards, was in Washington by mid-week to discuss the position on Capitol Hill and with the D.C. health establishment (see related story next page). The key factor in the timing of the decision was almost certainly the Nov. 17 session in the generic drug investigations scheduled before Chairman Dingell's (D-Mich.) House Energy & Commerce Oversight Subcommittee. By announcing Young's lame-duck status, HHS took some of the remaining fervor out of the generic hearings. The Dingell subcommittee promises to continue the investigations, but it will be difficult to try to tie a new commissioner to situations that happened on a different commissioner's watch. Dingell downplayed the importance of losing Young as a scapegoat for his hearings with a statement blaming the agency's problems on the deregulatory and budget-cutting philosophies of the Bush and Reagan Administrations. Commissioner Young "had the misfortune," Dingell declared, "to preside at FDA during a time when it was virtually guaranteed that rogues and knaves would prosper, and honest people would face great difficulties." Young's "intentions were good and he did his best when problems were brought to light"; however, "he was handicapped by both the budgets and attitudes of an administration that let the agency go to seed." Young was actually appearing to do well at weathering the generics scandal; it already seemed to have spent some of its headline appeal. However, the weight of two other issues may have helped to force the necessity of a change. One issue is the possibility of similar medical device approval inquiries arising from a series of hearings on medical device malfunctions starting up again in Chairman Waxman's (D-Calif.) House Energy & Commerce Health Subcommittee. The other is the lingering issue of Young's much-publicized ban on Chilean fruits. A replacement for Young at this point also makes sense as a legislative strategy. Young had already committed himself to efforts to seek more retribution from ANDA offenders. That position, necessary to mollify the investigatory phase of the scandal, may not have been a comfortable posture for HHS going into a period of possible legislative wrangling with the Dingell committee next year over changes to the FD&C Act. The pending biotechnology decisions could help to cement Young's reputation and counter-balance the public image created by the generic scandals. Even without any final actions in the biotech area, Young can point to FDA's ability to keep up with new products from that area as a significant feature of his tenure at the agency. Young's most important legacy to FDA appears to be the agency's willingness under his guidance to adopt expedient solutions and not view FDA procedures as inviolate. As a commissioner, Young was skillful at absorbing criticism and responding to attacks. The several different -- and sometimes overlapping -- changes to the IND/NDA process that he championed to respond to the vocal AIDS lobby indicate an unusual willingness to tinker with entrenched FDA processes. It is ironic that he was berated by the AIDS activists while effecting substantial changes in the system. In a comment on Young's reassignment, the Pharmaceutical Manufacturers Association praised Young's openness to "experimentation." PMA also praised Young for his receptiveness to comments from outside the agency. FDA "became more open to communications and ideas from its many constituencies." He appeared to thrive on the heavy public demands of the FDA job and rarely shied away from a meeting with critics or supporters. His relish for the politics of the FDA office was perhaps most evident in his international duties as the U.S. representative to the World Health Assembly. His assiduous efforts with that group helped fend off the pharmaceutical marketing code proposal at mid-decade. Young's tenure also will be remembered for the large drug approval totals during his first years at the agency, peaking with 30 new chemical entity approvals in calendar 1985. Republican Sen. Hatch (Utah) commended Young for his efforts to get FDA more resources. "Frank Young has been the principal advocate for improving the FDA, for consolidating the buildings and obtaining state of the art equipment," Hatch said in a Nov. 13 statement.(ITEM 190)Picture, no caption Chart omitted.

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