Question 4

Please provide the Committee with periodic written status reports on all of the FDA cases referred by the IG to DOJ as information becomes available to you from DOJ.

Response

On March 28, 1990, the Department of Justice issued guidance to the Office of Inspector General setting forth those categories of FDA-related matters that were appropriate for the IG to investigate. Pursuant to these guidelines, to date approximately 16 matters have been returned by DOJ to the OIG for investigation. The OIG has resumed or plans to resume work on an estimated 5 additional matters that are within its jurisdiction. The OIG is currently consulting with the Department of Justice concerning the disposition of the remaining investigations.

As of April 13, 1990, the Department of Justice has referred to FDA for investigation and development 35 matters that the Department of Justice received from the HHS-Inspector General. These matters are being investigated by FDA. The Department of Justice has advised that additional matters will be referred to FDA. The FDA investigative report on all of these matters and the agency's view of the significance of any apparent violation, will be forwarded to the Department of Justice for a final decision with respect to disposition of these matters. on the status and disposition of these matters will be coordinated with the Department of Justice at the appropriate time.

Question 5(a)

Reports

Please identify all programs or agencies within HHS with a regulatory or enforcement mission. For those programs or agencies, please identify whether the statutory language governing each program or agency specifies which HHS officers or employees should undertake criminal investigations as part of the regulatory or enforcement mission, and if so, identify the specified officers or employees.

Response

There are a number of statutes which set forth criminal provisions applicable to fraudulent conduct against the Medicare and Medicaid programs. Those mainly include the Medicare and Medicaid Anti-Fraud and Abuse Amendments of 1977 and the Medicare and Medicaid Patient and Program Protection Act. The Office of Inspector General, through the Inspector General Act, assumed the authority to conduct criminal investigations under these authorities. The employees within the Office of Inspector General who undertake these activities are primarily the criminal investigators (Series 1811). In addition, federal legislation

has authorized states to create Medicaid fraud control units specifically charged with investigating Medicaid crimes. The Office of the Inspector General is charged with overseeing the operations of these fraud control units.

The Food and Drug Administration administers a number of regulatory statutes, which are identified at 21 CFR 5.10, all of which vest administrative authority in the Secretary of Health and Human Services. The Secretary has delegated to the Assistant Secretary for Health, who has redelegated to the Commissioner of Food and Drugs, all regulatory and enforcement responsibilities under those statutes. The principal statutes include the Federal Food, Drug, and Cosmetic act, which concerns premarket approval and post-market surveillance for drugs, medical devices, foods, and cosmetics, and certain portions of the Public Health Service Act concerning biologicals and electronic products which emit radiation. Section 903 of the Federal Food, Drug, and Cosmetic Act specifies that the Secretary shall be responsible for executing the Act "through the Commissioner". Section 702 of this Act authorizes the Secretary to use unspecified officers and employees of the Department to conduct examinations and investigations under the Act.

The Office for Civil Rights has responsibility for the enforcement of a number of civil rights laws. The principal statutes are Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, and the Hill-Burton Act (those portions which impose community service requirements on recipients). No criminal investigations are conducted under these authorities by offices or employees of the Office of Civil Rights.

While all of the programs and agencies within the Department of Health and Human Services involve a "regulatory" mission in the sense that rules and regulations are published to implement the laws under which such programs and agencies operate, the activities above are the only ones we have identified as involving a specific mandate to control an industry or enforce a statute.

Question 5(b)

How many criminal investigators (1811s) are currently employed in each of the programs or agencies identified in 5(a) above?

Response

The Department employs approximately 302 criminal investigators (Series 1811), all of whom are within the Office of the Inspector

Question 5(c)

How many criminal investigator (1811) positions are requested in the FY 91 budget and how many will be requested in the FY 92 budget for each agency or program listed in 5(a) above?

Response

The OIG does not "break out" the number of criminal investigator positions requested in the budget. Rather, the Office of Investigations lists the overall number of FTEs, including criminal investigators, other professionals, and support staff. For FY 91 that total is approximately 460 FTEs.

The FDA FY 1991 budget now pending before Congress requests additional investigative personnel. FDA is now developing a hiring plan that may include GS-1811 positions.

Since budget plans for FY 1992 have not been finalized in HHS or cleared by the Office of Management and Budget, we are unable to provide you with this information.

During my testimony before your Committee on Governmental Affairs on March 8, 1990, I indicated that the Food and Drug Administration did not have any GM/GS-1811 criminal investigators and that there might be statutory or regulatory barriers to the agency hiring such investigators.

I have confirmed with the FDA that it does not employ any GM/GS1811 criminal investigators. However, my staff has concluded that there are no legal barriers for the agency to hire GM/GS-1811 criminal investigators, and that the agency believes that many of its current investigators have the credentials to qualify for such a classification. Acting Commissioner Benson is now actively considering hiring such investigators.

I am sending an identical letter to Senator Roth.