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This article was originally published in The Gray Sheet

Executive Summary

HHS ROLE IN IMPOSITION OF CIVIL MONETARY PENALTIES IS RECOMMENDED by the Medical Device Manufacturers Association in a July 15 letter to Department of Health and Human Services Secretary Donna Shalala. MDMA, a recently formed association of small- and medium-sized device firms, says it is concerned about the "fairness" of FDA's May 26 civil penalties proposed rule ("The Gray Sheet" May 24, p. 4), which would provide FDA with exclusive jurisdiction to impose civil money penalties against device, drug and biologics firms. MDMA requests that a new proposal "be undertaken through the Office of the Secretary" of HHS and that the proposal "assure that any decision relating to civil penalties be undertaken through the Office of the Secretary." The association notes that the Safe Medical Devices Act of 1990 amended the Food Drug and Cosmetic Act to provide the HHS Secretary with the authority to pursue civil penalties. "To date, this authority has not been explicitly delegated by your office to the FDA." Therefore, MDMA argues that it is "improper for FDA to propose a regulation relating to civil penalties" and requests that HHS advise FDA to "withdraw the proposed rule." MDMA says that it is "concerned about the potential for abuse of" of the civil penalties implementation process outlined in the reg "because FDA personnel would function in the capacity of investigator, prosecutor and judge." A new proposal granting HHS authority over civil penalties, MDMA says, would provide "essential fairness" because it would require that FDA "justify to a presiding officer independent of any affiliation with the FDA that imposition of such a penalty is justified and that the final decision is the product of due process." In the May 26 proposal, FDA indicates that civil penalties would be used as a last resort measure for enforcement. MDMA maintains that the "possibility of FDA imposing civil penalties is traumatic"; therefore, "the application of a civil penalty represents a sanction that should be rarely applied and only after completion of due process." In contrast, the consumer organization Health Research Group said in July 8 comments to the agency that FDA should take an aggressive stance in levying civil penalties, suggesting that they should be used in lieu of warning letters in "many" instances ("The Gray Sheet" July 12, p. 7).

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