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FDA ENFORCEMENT "AUTHORITIES" PROPOSAL ENDORSED BY EDWARDS COMMITTEE; HHS "REVISIT" OF FDA-HHS INSPECTOR GENERAL ENFORCEMENT RELATIONSHIP RECOMMENDED

Executive Summary

The Edwards Committee's final report endorses broad enforcement "authorities" legislation proposed by FDA and urges Congress to enact appropriate legislation. Floated in March by the agency in draft form ("The Pink Sheet" March 25, p. 3), the legislative proposal is "not yet forwarded to the Congress," the report notes. Provisions in the legislation that would "augment the agency's enforcement authorities," the committee said, "merit the attention of Congress." The report points out that the "proposal includes granting the FDA authority to issue subpoenas; detain products pending enforcement proceedings; proceed against any regulated product with a presumption of interstate commerce; inspect production and shipment records for all products; and impose civil penalties administratively." Other enforcement tools recommended by the panel "include the general authority to debar firms that submit fraudulent data and a requirement that all manufacturers register and report on their FDA-regulated products annually." [EDITORS' NOTE: See related story, p. 3, on the House generic drug debarment bill.] Advisory committee Chairman Charles Edwards, MD, testified at a May 15 hearing before the Senate Labor & Human Resources Committee that FDA "is in a crisis," even though, "fortunately, up to this point in time we haven't had a [public health] disaster occur." Committee member Lawrence Horowitz, MD, noted that the committee agreed "that the FDA cannot, cannot, do all that is mandated of it by law." Therefore, "the question is, what will it do with its time and with its money, and is it making the right choices? That means inspections that ideally ought to be done are not being done," Horowitz told the Senate committee. "We haven't had a public health crisis "; however, no one can say "that the proper safeguards that were intended by the law are in fact being carried out, because they are not," Horowitz added. He maintained that FDA "cannot fulfill all that the Congress has required." The committee report states that "Congress should review the FDA's current mixed bag of enforcement tools and enact legislation to streamline, expand and modernize them." The report adds that "the agency should be armed with the same tools for all products that it regulates." Two examples of inconsistency in FDA enforcement powers are the agency's authority to impose civil money penalties and to order recalls under the medical device law. Those agency powers do not extend to drugs or other FDA-regulated products. The committee also suggested that FDA relinquish responsibility for regulatory requirements that it cannot enforce due to lack of resources. "Because FDA cannot enforce all its requirements, it currently ranks them and focuses resources in priority areas," the report states. The agency "should candidly acknowledge enforcement areas it believes should not receive agency attention and consider whether to propose (a) abandoning federal regulation of the activity (including repealing regulations that otherwise imply a threat of enforcement); (b) transferring authority to other, more appropriately equipped federal agencies (such as the responsibility for monitoring the methadone treatment clinics); or (c) relinquishing responsibility to state or local governments (as it has done with food service establishments)." Failure "to acknowledge publicly that it lacks the capacity to enforce all of the laws it administers," the agency "creates unrealistic public and congressional expectations," the committee reasoned. "Non-enforcement also invites violations from unscrupulous firms, which places their law-abiding competitors at a disadvantage in the marketplace." The committee also recommended that FDA "systematically review its current regulatory requirements to identify ways to improve voluntary compliance." One way would be to provide more guidance to regulated industry. "Some provisions of law and regulations provide inadequate guidance to firms that wish to comply. More explicit regulations could raise compliance levels without increasing enforcement costs." the report states. "Clarifying regulations also will help the FDA encourage and support self-policing efforts by regulated industries." FDA should separate field operations from compliance policy functions, which currently are both assigned to the associate commissioner for regulatory affairs, the report recommends. "Separating the development and implementation of enforcement policies would render both more effective," the committee said. The combination of functions "diverts senior management attention from enforcement activities; detracts from regulatory policy development, auditing and evaluation; and creates tension between" enforcement policy development and implementation. The committee also said "FDA must attend to the partnerships, including those with the states and the Department of Justice, that are essential parts of effective food and drug law enforcement." The agency should strive to restore "the confidence of state officials in FDA regulation," the report states. The cooperative agreements and inspection planning exercises developed between state officials and some regional FDA offices should be models for all." The Justice Department and U.S. attorneys "are other important FDA partners," the report asserts. "By law, the agency depends on them to initiate and, in most instances, pursue court proceedings to enforce the FD&C Act," the committee pointed out. "To make this often uneasy relationship more effective, the commissioner should recognize the FDA's dependence on the Justice Department and, with the agency's counsel, initiate discussions to raise the priority accorded" to FDA cases. "If such efforts fail," the committee said, "Congress should consider granting FDA independent authority to initiate court proceedings." The committee also urged HHS "to revisit the issue of the inspector general's relationship to the FDA's own enforcement efforts." Last year, Secretary Sullivan extended and later retracted to the HHS IG authority to investigate felony violations of the FD&C Act. The committee added that FDA's plans to upgrade the training of its investigators and to hire criminal investigators "are appropriate" and "perhaps overdue, but they may not be sufficient."
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