August 31, 1999
F. James Charney
Re: OMB Circular A-110
The Association of American Physicians & Surgeons, Inc. ("AAPS"), a non-profit physicians' group founded in 1943, hereby submits comments on OMB Circular A-110, "clarifying changes to proposed revision on public access to research data."
We support the Shelby provision in P.L. 105-277, which requires that "all data produced under an award will be made available to the public through [FOIA]," and we respectfully insist that you implement it fully.
Your recently proposed amendment to OMB Circular A-110 violates the statute by removing most federally-funded drug and vaccine safety research data from public access. Your proposed amendment would allow federally-funded researchers to conceal mistakes and distortions, to the detriment of the health of the public. Specifically:
1. Your proposal limits public access to research data concerning findings "used by the Federal Government in developing a [formal] regulation." Your proposal thereby blocks access to data used in other, equally binding, government policymaking and rulemaking procedures. You thereby block public access to most federally-funded drug and vaccine safety research data. Public access to these data is crucial. These data are not generally used or cited by the Federal Government in developing formal regulations, but are used and cited in imposing requirements on the public through policies and rules, or through "recommendations" that become de facto requirements. Your arbitrary blocking of access to these data is contrary to the statute, and will prevent the public detection of mistakes and distortions in research relating to drugs and vaccines.
3. In addition, you propose to limit disclosure to "published" data. This term does not occur in the Act. This arbitrary limitation could defeat the purpose of the Act; data may remain unpublished precisely because they tend to refute the researcher's favored hypothesis or to show that a policy based on that hypothesis is ill-advised or harmful. It is critical that such data be accessible to independent review.
4. Finally, you solicit comments on denying public access completely if the impact of the regulation is less than $100 million. This arbitrary threshold is not permitted by P.L. 105-277. Such a regulation would be used to block public access to vaccine safety data.
Public access to federally-funded drug and vaccine safety data is required by the statute, and we insist that you ensure such access by completely implementing P.L. 105-277.
Jane M. Orient, M.D.