Forsham v. Harris, 78-1118

• Citation: 445 U.S. 169,63 L.Ed.2d 293,100 S.Ct. 977
• Decision Date: 03 March 1980
• Docket Number: No. 78-1118,78-1118
• Parties: Peter H. FORSHAM et al., Petitioners, v. Patricia Roberts HARRIS, Secretary Department of Health, Education, and Welfare, et al
• Court: United States Supreme Court

445 U.S. 169

100 S.Ct. 977

63 L.Ed.2d 293

Peter H. FORSHAM et al., Petitioners,

v Patricia Roberts HARRIS, Secretary Department of Health, Education, and Welfare, et al.

No. 78-1118.

Argued Oct. 31, 1979.

Decided March 3, 1980.

Syllabus

Under federal grants awarded by the National Institute of Arthritis, Metabolism, and Digestive Diseases (NIAMDD) (a federal agency), the University Group Diabetes Program (UGDP), a group of private physicians and scientists, conducted a long-term study of the effectiveness of certain diabetes treatment regimens. Pertinent federal regulations authorized some supervision of UGDP and gave NIAMDD the right of access to, or permanent custody of, the raw data generated by UGDP. However, the day-to-day administration of grant-supported activities was in UGDP's hands, and NIAMDD did not exercise its right to review or obtain custody of the raw data, which remained at all times in UGDP's possession and under its ownership. The UGDP's reports on the results of its study, indicating that the use of certain drugs in diabetes treatment increased the risk of heart disease, ultimately resulted in proceedings by the Secretary of Health, Education, and Welfare (HEW) and the Food and Drug Administration (FDA) to restrict the labeling and use of the drugs. After both UGDP and HEW denied petitioners' request for access to the UGDP raw data underlying its published reports, petitioners filed suit in Federal District Court to require HEW to make the raw data available under the Freedom of Information Act (FOIA), which empowers federal courts to order an "agency" to produce "agency records improperly withheld" from an individual requesting access. The District Court granted summary judgment for respondents, holding that HEW properly denied the request on the ground that the data did not constitute "agency records" under the FOIA. The Court of Appeals affirmed.

Held: HEW need not produce the requested data because they are not "agency records" within the meaning of the FOIA. Data generated by a privately controlled organization which has received federal grants (grantee), but which data has not at any time been obtained by the agency, are not "agency records" accessible under the FOIA. Pp. 177-187.

(a) There is no merit to petitioners' claim that the data were at least records of UGDP, and that the federal funding and supervision of UGDP alone provide the close connection necessary to render its records "agency records" as that term is used in the FOIA. While "agency record" is not defined in the Act, Congress excluded private grantees from FOIA disclosure obligations by excluding them from the Act's definition of "agency," an action consistent with its prevalent practice of preserving the autonomy of federal grantees and their records. Since Congress found that federal funding and supervision (short of Government control) did not justify direct access to the grantee's records, it cannot be concluded that those identical activities were intended to permit indirect access through an expansive definition of "agency records." Pp. 178-182.

(b) Nor may a broad definition of "agency records" be invoked so as to include all documents created by a private grantee to which the Government has access and which the Government has used. Such a broad definition is not supported by either the language, structure, or legislative history of the FOIA. Instead, Congress contemplated that an agency must first either create or obtain a record as a prerequisite to its becoming an "agency record" within the meaning of the FOIA. This conclusion is also supported by other Acts in which Congress has associated creation or acquisition with the concept of a governmental record. Although in this case HEW has a right of access to the data, and a right if it so chooses to obtain permanent custody of the UGDP records, in this context the FOIA applies to records which have been in fact obtained, and not to records which merely could have been obtained. Without first establishing that the agency has created or obtained the document, the agency's reliance on or use of the document is similarly irrelevant. Pp. 182-186.

190 U.S.App.D.C. 231, 587 F.2d 1128, affirmed.

Michael R. Sonnenreich, Washington, D. C., for petitioners.

Kenneth S. Geller, Washington, D. C., for respondent Harris.

Thomas E. Plank, Baltimore, Md., for respondent Klimt.

Mr. Justice REHNQUIST delivered the opinion of the Court.

The Freedom of Information Act, 5 U.S.C. § 552, empowers federal courts to order an "agency" to produce "agency records improperly withheld" from an individual requesting access. § 552(a)(4)(B). We hold here that written data generated, owned, and possessed by a privately controlled organization receiving federal study grants are not "agency records" within the meaning of the Act when copies of those data have not been obtained by a federal agency subject to the FOIA. Federal participation in the generation of the data by means of a grant from the Department of Health, Education, and Welfare (HEW) does not make the private organization a federal "agency" within the terms of the Act. Nor does this federal funding in combination with a federal right of access render the data "agency records" of HEW, which is a federal "agency" under the terms of the Act.

I

In 1959, a group of private physicians and scientists specializing in the treatment of diabetes formed the University Group Diabetes Program (UGDP). The UGDP conducted a long-term study of the effectiveness of five diabetes treatment regimens. Two of these treatment regimens involved diet control in combination with the administration of either tolbutamide, or phenformin hydrochloride, both "oral hypoglycemic" drugs. The UGDP's participating physicians were located at 12 clinics nationwide and the study was coordinated at the Coordinating Center of the University of Maryland.

The study generated more than 55 million records documenting the treatment of over 1,000 diabetic patients who were monitored for a 5- to 8-year period. In 1970, the UGDP presented the initial results of its study indicating that the treatment of adult-onset diabetics with tolbutamide increased the risk of death from cardiovascular disease over that present when diabetes was treated by the other methods studied. The UGDP later expanded these findings to report a similarly increased incident of heart disease when patients were treated with phenformin hydrochloride. These findings have in turn generated substantial professional debate.

The Committee on the Care of the Diabetic (CCD), a national association of physicians involved in the treatment of diabetes mellitus patients, have been among those critical of the UGDP study. CCD requested the UGDP to grant it access to the raw data in order to facilitate its review of the UGDP findings, but UGDP has declined to comply with that request. CCD therefore sought to obtain the information under the Freedom of Information Act. The essential facts are not in dispute, and we hereafter set forth those relevant to our decision.

The UGDP study has been solely funded by federal grants in the neighborhood of $15 million between 1961 and 1978. These grants were awarded UGDP by the National Institute of Arthritis, Metabolism, and Digestive Diseases (NIAMDD), a federal agency,¹ pursuant to the Public Health Service Act, 42 U.S.C. § 241(c). NIAMDD has not only awarded the federal grants to UGDP, but has exercised a certain amount of supervision over the funded activity. Federal regulations governing supervision of grantees allow for the review of periodic reports submitted by the grantee and on-site visits, and require agency approval of major program or budgetary changes. 45 CFR §§ 74.80-74.85 (1979); 42 CFR § 52.20(b) (1979). It is undisputed, however, both that the day-to-day administration of grant-supported activities is in the hands of a grantee, and that NIAMDD's supervision of UGDP conformed to these regulations.²

The grantee has also retained control of its records: the patient records and raw data generated by UGDP have at all times remained in the possession of that entity, and neither the NIAMDD grants nor related regulations shift ownership of such data to the Federal Government. NIAMDD does, however, have a right of access to the data in order to insure compliance with the grant. 45 CFR § 74.24(a) (1979). And the Government may obtain permanent custody of the documents upon request. § 74.21(c). But NIAMDD has not exercised its right either to review or to obtain permanent custody of the data.

Although no employees of the NIAMDD have reviewed the UGDP records, the Institute did contract in 1972 with another private grantee, the Biometric Society, for an assessment of the validity of the UGDP study. The Biometric Society was given direct access to the UGDP raw data by the terms of its contract with NIAMDD. The contract with the Biometric Society, however, did not require the Society to seek access to the UGDP raw data, nor did it require that any data actually reviewed be transmitted to the NIAMDD. While the Society did review some UGDP data, it did not submit any raw data reviewed by it to the NIAMDD. The Society issued a report to the Institute in 1974 concluding that the UGDP results were "mixed" but "moderately strong."

An additional connection between the Federal Government and the UGDP study has occurred through the activities of the Food and Drug Administration. After the FDA was apprised of the UGDP results, the agency issued a statement recommending that physicians use tolbutamide in the treatment of diabetes only in limited circumstances. After the UGDP reported finding a similarly higher incidence of cardiovascular disease with the administration of phenformin, the FDA proposed changes in the labeling of these oral hypoglycemic drugs to warn patients of cardiovascular hazards. FDA Drug Bulletin (June 23, 1971). The FDA deferred further action on...