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Executive Summary

FDA SUBPOENA AUTHORITY UNDER HR 2597 WOULD BE "BROADER" than similar powers granted by statute to other federal agencies, FDA maintained in draft comments prepared for submission to the House Energy & Commerce/Health Subcommittee. Although the FDA enforcement bill's provision of subpoena authority for FDA "is not without precedent," the draft states, "the authority proposed in HR 2597 is . . . broader than that presently provided to some other federal regulatory agencies" charged with regulating health and safety. The comments have been forwarded to HHS for review before they are sent to Capitol Hill. During a July 17 hearing before the Health Subcommittee on the enforcement authorities proposal, Chairman Waxman (D-Calif.) asked Commissioner Kessler to provide a written analysis of the bill's subpoena powers as it relates to such powers Congress has granted to other agencies. Waxman also asked Kessler to submit the Bush Administration's official position on each provision of the legislation. FDA reportedly still is working on that request ("The Pink Sheet" Aug. 12, p. 7). An analysis of HR 2597, performed by the Congressional Research Service's American Law Division and distributed at the subcommittee hearing, concludes that several other federal agencies possess greater subpoena power than FDA would receive under the authorities bill. "Other agencies which have regulatory responsibility similar to that of the FDA possess statutory subpoena authority comparable to, and in many cases, broader than HR 2597's proposal," CRS said. For example, the analysis states, the Occupational Safety and Health Administration may "require the attendance and testimony of witnesses and the production of evidence under oath" during OSHA inspections or investigations. FDA's draft response notes that HR 2597 would authorize FDA to "issue subpoenas requiring the attendance and testimony of witnesses and the production of documentary evidence." Such subpoenas would be authorized "for the purpose of any investigation, hearing or other proceeding" concerning a violation of the FD&C Act, to determine compliance with the act or "to establish a standard or other requirement under the act." The draft further notes that the bill makes refusing to obey a subpoena "a violation of section 301 of the act" and "punishable as contempt" when enforced by a U.S. district court. FDA noted in the draft response that "most major federal regulatory agencies, including those with a mandate to protect health and safety, have some type of authority to compel witnesses to appear and testify and to require the production of documents." FDA added: "In most cases, administrative subpoenas may be enforced by an order of a U.S. district court; the failure to obey such an order is punishable as contempt." The "scope" of federal subpoena power "varies from agency to agency and, even within an agency, from program to program," FDA pointed out. "Several agencies with health and safety mandates have broad authority to subpoena any witness or documents relevant to the performance of the agency's duties under a particular statute." FDA said the Drug Enforcement Administration, the Consumer Product Safety Commission, OSHA and the Environmental Protection Agency are examples of federal agencies that "have broad subpoena authority." On the other hand, other federal agencies with subpoena power are sometimes limited in terms of who can issue subpoenas and when they may be issued, the draft points out. Subpoena authority can be "restricted to use in connection with a specific regulatory proceeding," FDA noted. For example, the document points out that the EPA's subpoena authority is limited to civil penalty proceedings and to hearings to cancel pesticide registration. Restrictions may also stipulate "who may exercise subpoena authority, although such an express limitation appears to be the exception," FDA added. "For example, CPSC's subpoena authority may not be delegated below the commission level."

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