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FDA COM. YOUNG's INTRODUCTION TO KEY FDA ISSUES MAY INCLUDE MEETINGS WITH FORMER COMMISSIONERS, DRUG INDUSTRY EXECS; SWEARING IN CEREMONY ON AUG. 1

Executive Summary

FDA Com. Young's introduction to key issues facing the agency may include consultation with former commissioners, drug industry execs and consumer groups. At an Aug. 1 swearing-in ceremony, HHS Secty. Heckler said that she advised the new commissioner "to call together all of his predecessors and ask which items on their agendas were left unaccomplished, so that rather than re-inventing a new whell, or the old wheel with a new approach to it, we could . . . perhaps piggyback on those priorities that had been unfulfilled." The secty. said she also asked Young "to meet with the heads of all the drug companies and receive their input on the performance of the FDA -- how it could be improved, how it could be evaluated, and what remains to be done." The sessions are not intended "to create any opportunity for undue input," Heckler added, but "to utilize the ability of all the relevant groups, as well as the public groups," to balance the needs of the population for medical treatment with "the protection of safety under the most complex and demanding circumstances." The swearing-in, two weeks after Young assumed the FDA helm, was the new commissioner's first public appearance. During the week, Young officially introduced himself to the agency staff through a videotaped interview with FDA Press Relations Director Bill Grigg During the interview, Young noted that he has already met with former Com. Hayes. The two met for about five hours during the interim period before Young took over as commissioner. While emphasizing his research and administrative background, Young acknowledged that he has not had direct contact in the past with FDA. "Most of my relationships with the govt.," he explained in the interview, "have been in the form of advisory panels." Although aware of FDA "as a regulatory agency . . . I did not have any primary, first-hand contact with FDA," he said. He noted that at the University of Rochester he had responsibility for an operation involving about 6,000 people and a budget of over $220 mil. Young explained that his initial agendasetting process will be aimed at identifying "the three to five things that I'll be able to accomplish in a leadership role at FDA during the three to five years that I look forward to being with the organization." The commissioner declared: "We'll be looking at big topics . . . and we'll try to take those and determine from our sense of history, our knowledge in the present and our view of the future exactly what would be the best items. Planning will be an important issue." With Congress in an abbreviated session due to the election year, and no pressing major decisions pending in the commissioner's office, Young could have a relatively long honeymoon period in which to further acquaint himself with FDA and define the role he wants to play within the agency. One of Young's tasks will likely be to oversee the implementation of the major drug regulatory initiatives begun by his predecessors. The NDA re-write and OTC exclusivity policies, for example, have left FDA and are under final review by the Office of Management & Budget. In addition, the agency will probably have to address the issue of generics for post-1962 drugs, either through regs implementing Rep. Waxman's ANDA/patent legislation, or through proposal developed within FDA. The agency's proposed post-1962 ANDA reg is reportedly on hold at OMB. The drug approval process was the one substantive issue about which Young was asked during the interivew. Noting the issue is a long-standing one, Young stated: "I'd like to emphasize that I want to look at it carefully, to rely on the leadership at FDA and then do my part to make it as expeditiously appropriate as possible, balancing the development of technology with public safety." Grooming Of Future FDA Managers Will Be Goal Of Commissioner's Advancement Program The most significant challenge facing FDA, he said, is "this very important one of balancing technology emergence with safety." The commissioner noted he intends to rely heavily on FDA current management, and stressed Deputy Com. Novitch's role in handling agency operations. "I'm particularly pleased to have Mark Novitch as a deputy commissioner," Young asserted. "Mark and I will work closely together and essentially I [will] play the role of chief executive officer and Mark, chief operations officer." With Young's appointment, there has been speculation that Novitch, himself a candidate for the commissioner's post, might leave the agency. With his education, research and administration background, Young said he is establishing a program, called the Commissioner's Advancement Program, that is aimed at grooming future FDA managers. "This particular program is designed to prepare those who are going to be the leaders in the next generation," Young declared. "We'll look for a variety of training, experience, and educational experience and I've asked each of the commissioner's and the people in the centers to develop this." He added that the advancement program will be aimed at all of the elements of FDA's operations. "Just this morning I was speaking with Paul Hile and all of the regional leaders," he noted. "I've asked them to be sure to bring in the plans from the field. This will not be just a program in Washington, but a program that involves all of FDA, the main offices and the field offices." Young said plans to visit all 10 of FDA's regional offices by the end of 1984. The new commissioner indicated he was impressed by the extensiveness of FDA's field operations. "I did not realize that it's hard to go anywhere in the U.S. for more than 125 miles without running into one of our people in the field," he said. That first line of protection to the American population is extremely important."

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