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Executive Summary

"Serious problems" exist in FDA's implementation of enforcement actions, according to a June 29 report from members of the former Edwards Committee. "While the FDA has significantly increased its emphasis on enforcement, as we recommended, serious problems exist in the manner in which this is being carried out," the report says. "We believe that agency enforcement should be implemented uniformly throughout the country and based on clear rules made known in advance to everyone involved. Inspections and actions in California should be consistent with those in Florida." The report specifically suggests that "when new enforcement policies are announced they should be accompanied by clear regulations and guidelines and should not be applied retroactively without time allowed for firms to come into compliance." Entitled "One Year Later," the report was issued as a commentary on FDA's progress in implementing recommendations that the former HHS advisory committee made in May 1991 for improving and strengthening the agency. As part of the process of writing the report, the committee members considered HHS' response to their original recommendations and met with or received separate responses from the various centers within FDA ("The Pink Sheet" June 15, p. 8). Several committee members presented the new report in person to HHS Assistant Secretary for Health James Mason on June 29. FDA Commissioner Kessler and FDA Deputy Commissioner for Operations Jane Henney were connected by phone. The next day, Senate Labor & Human Resources Committee Chairman Kennedy (D-Mass.), House Energy & Commerce Committee Chairman Waxman (D-Calif.) and the relevant appropriations committees were also provided with copies. The follow-up report sets forth five recommended principles for FDA's development of compliance policies and implementation of enforcement actions: * "Enforcement actions should be based on clearly-defined, centrally-coordinated policies, and should be consistent and uniform throughout the country." * "Companies subject to FDA enforcement should have clear notice of the requirements that the agency means to enforce, and, unless public health or safety is clearly at risk, time to bring products or activities into compliance with new requirements. As a general matter, new requirements should be reflected in agency regulations and not established through 'test case' enforcement actions." * "Enforcement actions should be compatible with, and closely linked to, the agency's programmatic priorities, as previously formulated and announced." * "The measure of any compliance program should be the extent and consistency of industry compliance with legitimate regulatory requirements -- requirements that are calibrated to promote health and safety -- not to compile numbers of enforcement actions." * "For their part, producers and sellers of FDA-regulated products have an obligation to comply with all lawful and clear regulatory standards." Although they questioned the consistency of some of FDA's enforcement policies, the committee members applauded the agency's increase in enforcement actions during the past year. "Commissioner Kessler has supported a number of highly visible, in some instances controversial, enforcement actions since assuming office, and has made clear his commitment to a vigorous compliance program at FDA," the report notes. "This effort, has by all accounts, improved morale in many quarters of the agency." Commenting on the FDA Enforcement bill, committee members noted that "in our 1991 report we urged Congress to examine FDA's current set of enforcement tools and consider the desirability of modernizing legislation, and we are impressed by the interest members of Congress have shown in this area of the agency's work." Turning to specific centers, the report praises FDA's implementation of new drug review procedures to speed up the approval of important products. "We strongly reaffirm our belief that different approaches to drug approval are appropriate for differing needs. Here real progress is being made by FDA." They add that "FDA appears to be following our recommendation to couple accelerated approval with the requirement to collect postmarketing data." The group emphasized that FDA's practice of uncoupling approvable indications from not approvable indications in drug applications "requires full public and congressional debate and should only be implemented through rulemaking." and Research officer directors said that In a January memo to staffers, Center for Drug Evaluation and Research office directors said that FDA has the authority to separate out indications that the agency is prepared to approve from those it is not ready to okay over sponsors objections ("The Pink Sheet" April 6, p. 13). The policy is intended to prevent delaying approval of a drug that is approvable for at least one indication. "If the FDA determines which indications it will process, if final approval restricts usage to those indications, and if government reimbursement policies are tied to approved usages, then a major change in both the nature of the approval process and the impact of that process on the practice of medicine will have resulted," the report asserts. The committee also raises the issue of whether FDA can "compel a sponsor to test its product in special populations as a requirement for NDA approval." FDA is considering asking sponsors to include representative patient populations in the design of studies and a method for assuring that subgroups can be analyzed adequately. * Several of the committee's original recommendations have not yet been implemented, including the preparation of a mission statement. "We are disappointed that a year later, the agency has yet to issue a mission statement or a formal statement of purpose." The report notes that FDA is understood to be developing such a statement. The panel members also pointed out that FDA has not announced program priorities as the committee had suggested. The agency "has been given more responsibilities than it has resources to fulfill; some tasks must be subordinated, and others may have to be ignored entirely." The disparity between FDA's responsibilities and inadequate resources "has grown worse," the report says. "Responsibility for this serious situation rests equally with the Administration and Congress." The committee members also reiterated their opposition to user fees, which they view as "as substitute for, not as an increment to, a tax-supported base budget." Although the committee members acknowledged that HHS concurred with most of their recommendations for improving FDA's facilities and other resources, the report cites a "lack of any sense of urgency on the part of FDA or [HHS]." Noting that $200 mil. was appropriated to start consolidating FDA's facilities, the report points out that "progress has been stalled by indecision within the Administration over expenditure of the funds, and by lack of commitment to a concrete plan for both consolidation and improvement." * Another proposal that the committee continues to endorse is that the FDA Commissioner be given authority and that the agency be separated from the Public Health Service. "Congress should consider enactment of our committee's principal organizational recommendation: removing FDA from the Public Health Service and creating a direct reporting relationship to the Secretary," the report says. As an alternative, Congress should consider "that FDA be re-established as a free-standing independent agency." The committee members emphasize in the report that "we are not acting or reporting in any official capacity, but as private citizens, who believe that the work of FDA is critical to public health and welfare and should be carried out vigorously, efficiently, and fairly -- with adequate funding and personnel." The individuals point out that the report does not list points of agreement or disagreement with HHS' response, but it does include a copy of the department's document. The panel members caution that "this report is not the product of intensive, fact-specific investigation." The report is signed by 14 of the 15 members of the former Edwards Committee. Jane Delgado, PhD, president and CEO of the National Coalition of Hispanic Health and Human Services Organizations, declined to sign the report. In a June 23 letter to another former panel member, Delgado questioned the appropriateness of the committee reconvening and noted that some of the expectations for the extent of change are "unrealistic."

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