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Executive Summary

FDA Commissioner Kessler pledged to support plans to give OTC drugs a higher profile at the agency in his first public address as head of FDA at the Food & Drug Law Institute's annual educational conference on Dec. 11. "I have already met with [Center for Drug Evaluation and Research Director] Dr. Carl Peck, who told me that he intends to increase the prominence of the Division of Over-the-Counter Drugs within his Center," Kessler said. "I will support that initiative." Kessler's remarks add further fuel to a rumor circulating at FDA that Peck will announce the elevation of the OTC division to office status in the upcoming weeks. The creation of an office of OTC Drugs as been a major regulatory priority of the Nonprescription Drug Manufacturers Association, which reiterated its support for such a reorganization in comments before the Edwards Committee in September ("The Pink Sheet" Oct. 8, T&G-13). The association is also seeking the establishment of an OTC advisory committee and a regulation that gives FDA preeminence over the states in OTC drug matters. The Edwards Committee subcommittee on drugs and biologics is expected to suggest that the full committee report for HHS Secretary Sullivan include recommendations for establishing FDA preemption powers over the states in the area of OTC labeling and the creation of an office of OTC drugs. The likely recommendations are based on the subcommittee's discussions in La Jolla, Calif. in November ("The Pink Sheet" Nov. 26, p. 5). Kessler's willingness to address the OTC issue in his second week at the agency may be a reflection on his familiarity with the regulatory issues facing the agency. Unlike past commissioners who have come to the agency with predominantly medical/academic backgrounds, Kessler already has a strong grounding in many of the long standing regulatory issues facing the agency that may not have received as much national attention as AIDS, the drug approval lag or the generic scandal. Kessler provided a list of his six priorities for the agency in his first speech at the FDLI conference. Highest on Kessler's priority list is the restoration of FDA's credibility in the wake of the generic scandal. Kessler said he plans to "restore the agency's own credibility -- to ensure the integrity of FDA's internal decisions, and to do everything posible to ensure the integrity of those who deal with the FDA." "Without the integrity of the agency's own programs, and without the integrity of those who deal with FDA, we can't get on with business." Restoring the integrity of FDA involves continuing to initiate investigations into wrongdoing and cooperating fully with other investigations, Kessler said. "We will be part of the discovery process." In addition, Kessler said that he has asked the FDA Center directors "to come up with new agendas over the next month or so." Kessler said that he expects "bold and dynamic approaches" from the Center directors. "Many of the old ways of doing business at the FDA are fine, but the times call for a boldness of thought equal to the opportunities we face," he commented. Kessler commented that he is confident that Peck "will develop the structure and systems -- and [will] manage -- so that we can continue to reduce the time required for new drug development and review." The new commissioner's comments echo the Edwards Committee's call, in its interim report, for strengthened leadership and streamlining of management and review procedures ("The Pink Sheet" Oct. 1, p. 10). To encourage "ingenuity and accountability," Kessler suggested that FDA "must 'empower' a sense of leadership at all levels. It is only when center directors and their managers feel they have the authority to act that they can fairly be held accountable." To this end, Commissioner Kessler has said that he will meet with Center directors individually on different days once every two weeks and with center staff every other week. The new commissioner is also conducting walkthroughs to meet the staff of each center. On Dec. 11, he conducted a tour of the Center for Food Safety and Applied Nutrition. He planned to visit CDER on Dec. 13 and the Center for Biologics Evaluation and Research on Dec. 14. "In our quest to be more efficient, to review more applications or to collect more import samples, we must never forget that we are managing people," Kessler observed. He added that it also means that "in our dealings with industry we must strive to be thoughtful and appropriately responsive -- but never arbitrary or disrespectful." FDA's ability to enforce regulations is one of Kessler's top priorities. "FDA needs to stand -- I need to stand -- for carrying out the law," Kessler emphasized. "This does not mean more regulations; it does not mean less. It means that we will enforce the statute." He asserted that "FDA must stand for, it must embody, strong and judicious enforcement. Fairness will be our guide." Kessler's emphasis on enforcement is also reflected in his appointment of Associate Chief Counsel for Enforcement Mary Pendergast to the position of executive assistant to the commissioner. The commissioner said that he is in the process of analyzing legislative proposals on enforcement "to bring these tools up-to-date." He expressed a desire to "streamline the enforcement process, making sure the field has both the authority and the resources to move expeditiously." Noting that FDA has relied "increasingly on premarket approvals, balanced by post-marketing surveillance and enforcement," Kessler maintained that the "gradual shift of emphasis may have short-changed the field." He indicated that more attention will be paid to FDA's field operations. "One of the lessons of the past decade teaches us that it's in the best interest of industry to have strong enforcement." In terms of management, Kessler said that "it is important to ensure that the agency has the management structure and the management systems to enable things to get done. We need to build, or reinforce, those systems at all levels." Kessler predicted that some changes can be expected "in the months and years ahead" with the aim of accomplishing "specific goals, such as improving responsiveness in the areas where FDA moves too slowly." However, he added that he would not make organizational changes "lightly." Another of Kessler's priorities concerns the quality of FDA personnel and facilities. Referring to FDA's "quest for a unified campus," Kesseler said: "Expect this topic to be at the forefront of the agency's priorities." The concept of a single, unified FDA campus was given a boost with the passage in November of Sen. Hatch's (R-Utah) FDA Revitalization Act. "It's going to take years, as those projects always do," said Kessler, "but we are building the momentum." "The scientific facilities, the training of our people both must be state-of-the-art," the new commissioner declared. "The field inspector, walking into a biotech plant, must be able to evaluate its new products credibly and competently," he maintained. Kessler also emphasized the need to "learn from the peer review system, and capitalize on advisory committees to make better use of outside scientific expertise." He stated that the agency must more fully incorporate principles of scientific review in [its] product decisions." Kessler also underscored several opportunities to improve the public health in the areas of blood safety, prescription drug advertising, medical devices, generic drugs, a framework for biotechnology, and international harmonization. However, he emphasized two public health issues: AIDS and food labeling. In the area of AIDS, Kessler commented that as the former medical director of the Albert Einstein College of Medicine Hospital, he has "witnessed the frustration and impatience of people affected by AIDS" and shares those feelings. He added: "What FDA can accomplish, has limits -- after all we are part of the larger biomedical research process -- but we can push those limits outward and we will." Concerning food labeling, Kessler said that "the label must present accurate information in a way that people can understand and use. I don't understand the food label," asserted Kessler. "When I read the nutrition label in its current format, I really don't grasp how much sodium and fat are too much. I don't think in terms of grams," he said. "In addressing the AIDS issue and in developing the regulations for nutrition labeling -- as well as in dealing with other issues facing the agency -- I have made it clear to the senior staff that I expect creative approaches," Kessler remarked. At the meeting, FDA Deputy Commissioner James Benson remarked on some of the agency's achievements during the period of one year that he served as acting commissioner. "We have done much to insure the integrity of FDA," Benson noted. Examples given by Benson included: beefed up document security and new guidelines for industry and FDA staff interaction; and support of debarment legislation. The agency is moving toward more enforcement, as noted by Commissioner Kessler, and greater openness, Benson said. Referring to the perception of FDA as the "black box," Benson said, "I feel that [FDA] must become more open, and must explain its processes more fully." For FDA to become more open, two things must happen, Benson said. "First, the public, especially consumer activists, regulated industry, and Congress, must understand our internal processes; the steps that occur in product approval, or in import surveillance, for example. Second, FDA must get better at helping our various constituencies understand the process." The agency, Benson added, needs "to make sure that people know the rules of the game, such as the kinds of studies needed to get a product approved." Benson pointed to medical device and food labeling legislation as among FDA's recent accomplishments. "The new medical device legislation passed just a few weeks ago represents the culmination of many efforts, both in FDA and on the Hill." He said that "it will take years to gauge the impact of the changes on the world of medical devices, and we still haven't fully come to terms with the resource implications, but I'm convinced that the legislation came out much better than it would have without our involvement." After the publication of FDA's proposed regulations for food labeling earlier this year, Benson said, "we thought we had made it through." However, legislation from Congress has complicated the issue, he indicated. "We like to think [the legislation] ratified our own efforts to overhaul the food label," Benson said. "Now we have the task of adjusting the proposed regulations to the new law. That will take some time."

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