COMMENT BY: Merck & Co., Inc.
SUBJECT: Against proposed revision to OMB Circular A-110
DATE: April 2, 1999

Dear Mr. Charney:

The February 4, 1999 Federal Register published a proposed revision to OMB A-110 stating, in part, that the Federal Government in response to a FOIA request has the right to make available to the public data relating to published research findings produced under an award that were used by an agency in developing policy or rules. Comments are to be received by April 5, 1999.

Merck & Co., Inc., a pharmaceutical company, objects to this revision.

Merck often provides drug or vaccine to government agencies for use in clinical trials. In some instances additional financial support is also provided by Merck. The results of such studies are typically published in the peer-reviewed medical literature. Merck often retains the right to file the data with the FDA for drug or vaccine approval or for labeling changes. In some instances such studies may form part of the rationale behind recommended changes in immunization schedules, Medicare reimbursement policies, or treatment guidelines. It is not clear whether such recommendations or approvals would be considered to be developing policies or rules for purposes of making the raw data from such studies subject to Freedom of Information (FOl) requests. Competitors would very much like to have the underlying raw data, not just the published results. If they can get it through FOIA, then they don’t have to incur the costs of supporting such studies. One such Merck study is a randomized, double-blind, placebo-controlled seven-year clinical trial to evaluate whether finasteride (PROSCAR) may help prevent prostate cancer. The initial design of this study has already been published. Competitors developing related compounds would very much like to obtain the raw data from this trial. Another study is a three-year randomized double-blind placebo-controlled trial of a vaccine which may help prevent shingles (herpes zoster) in older people. We are not only providing the vaccine for this study but are also providing significant co-funding. Again, competitors would be very interested in getting the raw data without having to do their own clinical trials.

In addition to funding clinical trials, Merck also funds post-marketing studies to assess the safety of our products under conditions of marketed use. These studies, which are sometimes undertaken as part of agreements reached with the FDA at the time of initial drug or vaccine approval, often involve compilations of data abstracted from medical records of thousands of patients enrolled in managed care organizations. It is not clear to what extent the proposed revision could result in release of information that could result in compromising patient privacy or could necessitate having to obtain patient consent for disclosure of their medical data through F0I.

Finally, Merck also funds epidemiologic research in collaboration with academic institutions, where part of the facilities are supported by government grants. The epidemiologic research is typically published in the peer-reviewed medical literature and may form part of the rationale for changes in treatment guidelines or reimbursement policies. The proposed revision could result in competitors being able to obtain all of the raw data from these studies, even though the amount of federal support involved was very small relative to the amount of Merck support. For the past nine years Merck has provided major funding support and scientific collaboration with Mayo Clinic in a longterm epidemiologic study of prostate disease in a community population of men in Olmsted County, Minnesota. More than 50 research articles from this study have been published in the peer-reviewed medical literature. This study was funded entirely by Merck. However, since some of the research facilities used to conduct this study were partially funded through federal grants to Mayo Clinic, it is arguable that a competitor couid obtain all of the raw data from this study for just the price of copying the files.

One direct result of the proposed revision will be to make it most unattractive for Merck to undertake clinical or epidemiologic research collaborations with government agencies or with academic institutions whose facilities are supported in part by federal grants. The presence of any amount of federal support, no matter how small in relation to the private support, would make the raw data available to our competitors for only the cost of copying the records. lt is especially disconcerting if Merck will not be able to determine in advance whether a given study could subsequently be used in the development of a policy or rule.

Another result of the proposed revision is that it would be very difficult for the academic institutions or governmental agencies to recruit subjects for the clinical or epidemiologic research, since the subjects would have to consent to having raw data from their laboratory tests, questionnaires, and medical records made available under F0I. While the existing FOl regulations would protect the subject’s names and personal identifiers from being disclosed, it would no longer be possible to assure the subjects that only aggregate information would be published.

Recommendations

Merck recommends that the proposed amendment not be implemented. If this isn’t feasible, then Merck requests that the "development of a policy or rule" be further defined and limited, that some exemption be granted for studies in which federal funds constituted only a small part of the total funding, and that some restrictions be placed on disclosure of individual patient data that could potentially result in breaches of confidentiality of patient medical records.

Merck recommends that Circular A-110 be revised to contain an explicit statement that the standard FOIA analysis of potential exemptions must be applied prior to any disclosure of research data to a third party. A contrary interpretation would, in many instances, render the FOIA exemptions meaningless. Merck also recommends that the Circular be revised to be clear that it applies only to data produced under an award, not data "relating to" data produced under an award from a federal agency. In addition, Merck recommends that OMB clarify in the final revised Circular A-110 that it applies to grants and contracts made after the date of promulgation of the revised Circular A-110.

Further, the proposed revision may set an unintended precedent for release of research information. For example, collaborations with government have been encouraged by other Federal programs which focus on technology transfer in basic research. This proposal may have a chilling spillover effect on future research collaborations such as those, where private sector companies may be reluctant to risk exposure of their early stage research data supporting technology patent applications. The overall effect would be a decrease in private sector collaboration and a corresponding increase in the costs to government of research in two areas, clinical development and basic research.

The pharmaceutical industry has always been proactive in publishing the results of its studies. However, having to provide raw data to competitors would certainly have a chilling effect on private funding of medical or pharmaceutical research in collaboration with governmental agencies or with academic institutions that receive federal funding.

Very truly yours,

R. Brent Olson
Assistant Counsel