AAMC and FASEB Comment on
"Regulatory Peer Review"
December 5, 2003 - The AAMC and the Federation of
American Societies for Experimental Biology (FASEB) sent a
comment
letter (PDF, 5 pages - 146KB) to the Office of
Management and Budget (OMB) this week objecting to proposed
requirements for peer review of information supporting major
federal regulations and related actions [68 Federal Register
54023]. The OMB proposal would establish standards for regulatory
peer review and also would require agencies to undertake an
additional level of review for information deemed to be "especially
significant," i.e., meeting certain economic and other
criteria. The OMB explicitly noted that the new requirements
are not intended to apply to reviews of research applications
or other routine operations such as conducted by National
Institutes of Health (NIH) or National Science Foundation
(NSF).
The heart of AAMC's and FASEB's concerns is that the additional
layer of review and other strictures set out by OMB would
seriously encumber timely decision making by Public Health
Service (PHS) agencies. The letter cites as one example the
recent release of findings that hormone replacement therapy
for post-menopausal women is of minimal benefit and causes
troubling adverse effects, contrary to previous medical opinion.
The AAMC and FASEB believe that PHS agencies currently rely
on exemplary standards for scientific review in their operations,
and the imposition of additional layers of review by OMB would
seriously undermine the public health prerogative of these
agencies. The two organizations also argue that OMB's specific
review and reporting requirements contravene "generally
respected, widely emulated practices…in determining scientific
merit." The AAMC and FASEB affirm support for OMB's goal
to ensure that major federal actions are based on sound science,
but urge the OMB to identify and address systemic deficiencies
where they occur, and not to impose "one-size-fits-all"
processes on all federal agencies. OMB's deadline for public
comments is Dec. 15.
Information:
Stephen Heinig, Senior Research Fellow
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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