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Executive Summary

New enforcement tools that would be provided to FDA under HR 2597 would be "helpful" and even "necessary," but FDA is not going to wait for Congress and the Bush Administration to come to an agreement on the bill, Commissioner Kessler indicated during an appearance at the National Institutes of Health Aug. 7. Speaking at one of the NIH Clinical Center's "Grand Rounds" medical lectures, Kessler was asked about the Bush Administration's position on the FDA enforcement authorities bill (HR 2597). FDA must enforce the law "with what we have control of now," Kessler said. "If I wait for the Congress, if I wait for a collective agreement on all the tools that are necessary, we will never get the job done." Kessler has significantly toned down his stance on the need for greater statutory enforcement authority since earlier this year. The bill initially appeared to have the support of HHS as well as broad bipartisan support in Congress. However, higher-ups in the Bush Administration have been persuaded by arguments against the bill from a coalition of FDA-regulated industries and have steered the agency away from direct support of the legislation. Taking its cue from the industry complaints, the Administration is critical of the bill's lack of protections for due process. Kessler explained that FDA must "make sure when you ask for additional tools . . . you don't get new tools without assuring additional due process. That's what's going on." Furthermore, Kessler indicated that the Administration has asked FDA to re-examine its "wish list" of additional enforcement powers in order to weed out provisions that may not be crucial for adequate law enforcement. "I think what the administration is saying, what the White House is saying, is that we get refocused," the commissioner said. "We have to decide what tools we need." Kessler and HHS Secretary Sullivan had indicated support for the bill, and have floated three similar legislative proposals since 1989. However, because higher ranking officials within the administration have opposed HR 2597, FDA has yet to issue a formal position on the legislation. The commissioner was unable to present FDA's position on HR 2597, and declined to state his personal position, during a July 17 hearing on the bill before Rep. Waxman's (D-Calif.) House Health Subcommittee. Due to the administration's internal disagreement on the bill, Waxman already had postponed the hearing from June 27. Waxman, a cosponsor of HR 2597, asked that the administration position be submitted within 20 days after the hearing ("The Pink Sheet" July 22, p. 12). FDA had not done so within 20 calendar days after the hearing, and hopes to submit its position by Aug. 15 -- 20 working days after the hearing. The Generic Pharmaceutical Industry Association is the only trade group representing an FDA-regulated industry to endorse HR 2597 publicly. GPIA said its member companies "recognize that the federal FD&C Act is an old statute that lacks some explicit enforcement powers provided in recent years to other governmental agencies." However, the association said several provisions in the bill should be "more clearly focused," and "protective mechanisms can be built into the bill without diluting the strength or effectiveness of the enforcement tools." For example, the bill's provisions for administrative and judicial recall authority retain the standard for recalls from the 1990 device legislation. The established standard that a product can be recalled if there is "a reasonable probability" that it can "cause serious adverse health consequences or death" is a universally understood "term of art," GPIA said. The proposed authority to recall violative products involving fraud or "a significant risk to human or animal health" is ambiguous and "can do nothing but create uncertainty and disagreements as to its applicability," the association said. Furthermore, recalls should protect public health, not punish fraud, GPIA argued. "Civil money penalties and criminal prosecution are more appropriate punitive measures for fraud." The association also urged that the legislation should stipulate that recall authority can be delegated to a level no lower than FDA's associate commissioner for regulatory affairs. The provision authorizing FDA to embargo products believed to be in violation of the FD&C Act "should be limited to products found to be adulterated or misbranded," GPIA said. The provision requiring inspected companies to maintain records and reports "as the secretary determines to be necessary" also should be limited, the association contended. As drafted, the provision "appears to be a virtually limitless extension of authority." Records and reports required should be identified by the regulation to allow industry to comment on which documents are necessary, GPIA said. The groups that oppose HR 2597 are expected to reach 60 in number by September. The coalition, which includes the Pharmaceutical Manufacturers Association, hopes to add a number of organizations that do not FDA-represent regulated industry. Such organizations may include AIDS patient advocacy groups.

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