Dear Editors,
Most of you are already familiar with the controversy over public access to federally-funded research data. In a nutshell, Senator Shelby inserted a two-sentence requirement into PL 105-277 last fall that permits public access to federally-funded research data under FOIA guidelines.

We all support the Senator Shelby requirement, and submitted comments early this year when the OMB issued its proposed regulations. Sunshine is a disinfectant, and public access to such data minimizes corruption, mistakes, and fraud concerning such data.

For example, the tragedy of the rotavirus vaccine would never have happened if the public had access to the data used by the FDA and CDC in recommending the vaccine. I have been studying the reports and have concluded that the FDA and CDC ignored and concealed data that showed the problems from the outset. The Shelby amendment, if properly implemented, would ensure that federally-financed research about vaccines could not be withheld from the public. Ultimately this rule should be extended to all data on which the government makes vaccine policy decisions, including privately-funded research data as well. This would greatly improve the integrity of vaccine policymaking.

Fifty-five percent of the commenters to OMB indicated their support for the Shelby amendment, but OMB has now issued proposed regulations that would eviscerate the amendment further, particularly with respect to vaccine data. We only had [a brief period until September 10th] to submit comments as text (not an attachment) in an e-mail to F. James Charney, Policy Analyst, OMB, Re: OMB Circular A-110, at grants@omb.eop.gov.

This recent proposal by OMB would effectively remove all federally-funded vaccine research from public access. It does this by only allowing public access for data "used by the Federal Government in developing a regulation" pursuant to formal rule making proceedings. The vaccine governmental recommendations would not qualify, although they would have qualified under the broader rule proposed by OMB earlier this year.

The OMB proposed regulation is available at http://www.whitehouse.gov/OMB/fedreg/2ndnotice-a110.html.

Andrew L. Schlafly, Esq.
AAPS General Counsel
Wayne, NJ

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The Editor Responds

Among the organizations writing to the OMB to support the Shelby Provision were: Eagle Forum, Gun Owners of America (GOA), AAPS, Medical Sentinel, Evergreen Freedom Foundation, etc.---Editor.

Here is the Shelby Provision Fact Sheet from the Senator's office:

° Senator Shelby believes that the American people have a right to know how billions of dollars in taxpayer money are being spent in support of federally funded research. In addition, he believes that any data that is used to support federal policies and rules should similarly be subject to public access through the Freedom of Information Act.

° The provision included in last year's Treasury and General Government Appropriations bill is largely an enhancement of existing data access requirements under the Paperwork Reduction Act of 1995. The issue became of particular interest to the Senator in practice when he sought access to underlying data used to support EPA regulations on ozone and particulate matter and was told that EPA was not in a position to provide the information. In addition, he was also supportive of previous efforts by Congressman Robert Aderholt in 1997 to achieve similar results.

° Contrary to the political rhetoric alleging that this provision was "slipped" into the Omnibus bill in the middle of the night, this provision was very publically considered and passed by the Congress. The provision was first included in the original Treasury and General Government Appropriations bill reported out of Committee in July of 1998. As the bill was considered on the floor of the Senate in September, several floor statements accompanied the language. These colloquies made it clear that efforts would be made to improve the language in conference.

° The final language included in the Treasury and General Government conference report was actually drafted and agreed to by the Office of Management and Budget in cooperation with the House and Senate appropriators. The conference report was then brought to the Senate floor for consideration in early October. The bill was later laid aside because of procedural delays on the floor. Ultimately, the Treasury and General Government Appropria-tions bill was wrapped into the Omnibus package along with several other appropriations bills in mid-October.

° This law will require publically-financed research as well as research used to underlie federal polices or rules to be subject to the Freedom of Information Act (FOIA). Additionally, these requests would be subject to the many safeguards and broad regulations employed by the FOIA to protect sensitive information. The FOIA has many exceptions, including exceptions for geological data, medical files, classified information, personal privacy, law enforcement techniques, and information which could compromise the safety of individuals.

Furthermore, Sen. Richard C. Shelby (R-AL) stated: "Given the prevalent use of government funded research data in developing regulations and federal policy, it is important that this data be available to other federal agencies, as well as the public. I believe the Freedom of Information Act is the appropriate vehicle for making these studies available, because the Act has such a comprehensive list of exemptions designed to protect medical privacy, classified information and personal safety, as well as other concerns."

Correspondence originally published in the Medical Sentinel 1999;4(6);193-198. Copyright©1999 Association of American Physicians and Surgeons (AAPS).