Washington Highlights: January 20,
2006
AAMC Comments on Good Guidance Practices
Contents
Prior Issues
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The AAMC Jan. 10 commented
on the Office of Management and Budget's (OMB) proposal to require
federal agencies to adopt standards for "good guidance practices"
in their formal advice to the public on matters of regulation or
other requirements. The proposal would require agencies to notify
the public and seek comments on draft guidance documents if said
guidance qualifies as "significant" (creates an economic
impact of $100 million or more, or meets other criteria). The Association
supports the requirements, and recommends that OMB also require
agencies to respond to all comments collected. AAMC's chief concern
is that OMB's definition of "significant guidance" is
so broad that it might allow agencies to avoid using more formal
rulemaking processes for some important actions.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
HHS Announces Pandemic Flu Funding
The Department of Health and Human Services (HHS) Jan. 12 announced
that $100 million will be made available to the states, territories,
the District of Columbia, New York City, Chicago and Los Angeles
to combat pandemic influenza.
The grants, part of the $350 million provided for state and local
preparedness in the emergency supplemental of the Defense Appropriations
bill (P.L.109-148),
will be awarded later this year.
States are to use the funds to bolster planning efforts for pandemic
flu and to test the plans. The plans should focus on community-based
procedures designed to prevent or delay the spread of flu and reduce
burden on local resources in the event of an outbreak. HHS Secretary
Mike Leavitt also announced the launch of a series of preparedness
summits to be held in every state over the next several months to
discuss state and local preparedness.
Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525
Commission on the Future of Higher Education Holds
Public Meeting
The Secretary of Education's Commission on the Future of Higher
Education will hold its third public hearing
Feb. 2-3 in San Diego, CA, and will host a field hearing Feb. 7
in Seattle, WA. U.S. Secretary of Education Margaret Spellings Sept.
19 established the "national dialogue," comprised of academic, corporate,
and industry leaders. The committee is charged with developing a
comprehensive national strategy for postsecondary education that
will meet the needs of America's diverse population and also address
the economic and workforce needs of the country's future.
Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116
ONCHIT Issues Implementation Plans for AHIC Workgroups
At the Jan. 17 meeting of the American Health Information Community (AHIC),
the Office of the National Coordinator for Health Information Technology
(ONCHIT) issued "implementation plans" for four AHIC workgroups.
The groups will focus on biosurveillance, consumer empowerment,
chronic care, and electronic health records. Each group will develop
recommendations to help achieve the following objectives within
one year:
- Use a standardized electronic format to transmit essential
utilization and lab data to authorized public health agencies
within 24 hours
- Implement a secure electronic registration system for personal
health records among certain populations. Assure that a medication
history is linked to the registration summary. Develop a secure
electronic messaging system for clinicians and patients in support
of chronic care management
- Deploy a standardized and secure electronic system for accessing
lab results and interpretations
Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526
AFDA Releases New Format for Prescription Drug
Labels
The U.S. Food and Drug Administration (FDA) Jan. 18 released new
requirements for the content and format of drug labeling. The
revisions, developed from public meetings, physician surveys, focus
groups, and comment letters, share a common goal - to increase public
safety by decreasing medical errors and improving the management
of drug risks. The AAMC submitted a comment letter Dec. 20 [see
Washington Highlights,
Dec. 23].
The new format will simplify drug labeling and emphasize critical
prescribing information. Product approval dates; contact information
for reporting adverse events; a "Highlights" section with
crucial benefit and risk related information; and a "Table
of Contents" will be among the new additions to drug labels.
Free online resources, such as "Daily
Med," will also be established to increase accessibility
to risk and benefit information. The new requirements will be progressively
implemented beginning with medications that have recently received
approvals.
Information:
Howard Dickler, Director
AAMC Biomedical Health Sciences Research
hdickler@aamc.org
(202) 828-0567
Kim Witteenberg, Clinical Research Associate
AAMC Division of Biomedical Health Sciences Research
kwittenberg@aamc.org
(202) 862-6134
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