FREEDOM OF INFORMATION ACT COMMENTARY BY ASPET

March 23, 1999 

Mr. F. James Charney 
Public Policy Analyst 
Office of Management and Budget 
New Executive Office Building-Room 6025 
Washington, DC 20503 

Dear Mr. Charney: 

The American Society for Pharmacology and Experimental Therapeutics (ASPET) submits the following comments for your consideration to proposed revisions to OMB Circular A-110. ASPET is a 4,300 member professional society of biomedical research scientists in academia, industry, and government. 

The proposed rule changes to Circular A-110, which would subject all Federally funded research awards to public disclosure under the Freedom of Information Act (FOIA), raises substantial concerns for research scientists and threatens future research collaboration among scientists, research institutions and private industry. The new legislation would have detrimental and unintended consequences for the nation’s biomedical research enterprise. 

Essential to the pace of medical discovery are Cooperative Research and Development Agreements (CRADA) and Bayh-Dole Agreements between  universities or academic health centers and private industry. These key partnership mechanisms which contribute to the pace of medical discovery would be vulnerable under this legislation. The threat of theft of intellectual property would severely impede medical progress. 

ASPET believes that the proposed revision would threaten collaboration among academic researchers and institutions and private industry, including the pharmaceutical and biotechnology industries. Since the data that would be released would apply to all federal grantees regardless of the level of funding provided, there would be a disincentive for private industry to enter into any future collaborative agreements with universities or federal grantees. 

What incentive would there be for industry to enter into licensing agreements and collaborate with academic institutions when the fruits of their investment may be compromised by foreign or domestic competitors? 

In longitudinal studies, there may be a series of publications whose data could provide an unfair advantage to competitors that gain the benefits of the prior research. The transfer of technology from NIH grantees to U.S. pharmaceutical/biotechnology industries is critical. NIH and its grantees have proven and effective mechanisms to ensure that basic discovery in laboratories across the nation will be transferred to the private sector and developed into products. It is essential this cooperation be adequately safeguarded to move basic biomedical research discovery to new drug development and other clinical therapeutic applications. 

There are other issues of concern. There is great ambiguity in what is defined by the term “data” in the proposed rule. Furthermore, Circular A-110 mentions all data subject to FOIA as information “used by the Federal government in developing policy or rules.” How will it be determined what research data from the past or present would be critical to the development of a specific federal policy? Would research notes, and drafts of papers before they are published be considered data? The proposed rule would interfere with the publication of a researcher’s work in peer reviewed journals if the research data would have to be prematurely disclosed. Data used in any longitudinal study or sequential release of scientific articles could compromise the study by influencing study participants. 

Another concern for ASPET’s membership is the cost burden of these regulations. Will universities and academic health centers have to create a mechanism to respond to all requests for data under FOIA? The necessary increases in administrative costs would likely come at the expense of research. Certain confidential medical information on a research subject would need to be protected but making sure this information is not compromised would entail an additional cost burden. But even more critical than the cost burden is that some individuals may chose not to provide personal medical information for valuable research and clinical studies if they fear that information could be disclosed. 

Congress should consider holding public hearings to ensure that the benefits of scientific research and the public’s right to access data under FOIA are preserved. ASPET appreciates OMB’s efforts to reduce the burden of these regulations on research scientists. We urge careful consideration of these important issues. ASPET supports the bill introduced in Congress by Rep. George Brown to repeal this legislation. 

Sincerely, 

Kenneth E. Moore, Ph.D. 
President 
American Society for Pharmacology 
 and Experimental Therapeutics 
9650 Rockville Pike 
Bethesda, MD 20814 
E-mail: info@aspet.org