HHS INSPECTOR GENERAL WANTS FD&C FELONY ENFORCEMENT POWERS "CLARIFIED"

Executive Summary

HHS INSPECTOR GENERAL WANTS FD&C FELONY ENFORCEMENT POWERS "CLARIFIED" by legislation, Inspector General Richard Kusserow told an Oct. 3 Senate hearing before Sen. Glenn's (D-Ohio) Governmental Affairs Committee. "Legislation is required to clarify the status of the investigative authority of the Inspector General, as well as the audit authority," Kusserow maintained. Glenn's committee is considering a statutory clarification of the 1978 Inspector General Act. The Ohio Democrat explained that the issue was raised last March when a Justice Department opinion contended that the investigative authority of inspectors general "is limited to cases where federal employees or federal funds are involved." The Justice Department memo, written by its Office of General Counsel, cites legislative history regarding the Inspectors General Act to support the department's contention that inspectors general may investigate government employees and operations and recipients of government funds but not private regulated entities that do not receive program funds. Kusserow argued at the hearing that such transfers are authorized by statute, even as interpreted by the Justice memorandum. ANDA sponsors "do get a program benefit," he reasoned. "Once FDA approves your drug, it's worth millions of dollars" even though the company "does not receive program dollars." While defending the IG's right to get involved in FDA investigations on Capitol Hill, Kusserow has backed down a bit in communications with FDA (see related story, previous page). A strict interpretation of the memo would be "outlandish," Kusserow said, because it would place "a cloud over" inspector general investigations. He pointed out "the irony" that, despite the memorandum, there has been "no change with regard to the Justice Department in their criminal division. The U.S. attorneys continue to take our cases." Nonetheless, he added, clarification of the authority intended by Congress "is very important."