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BILLS
FDA Amendments Act of 2007 (H.R. 3580) –
Clinical Trials Registry
On September 27, 2007, the President signed H.R.
3580, the Food and Drug Administration
Amendments Act of 2007, as Public Law 110-85.
The Senate passed the legislation on September
20th by unanimous consent after the bill was
passed by the House on September 19th by a vote
of 405-7 under suspension of the rules. H.R.
3580 represents the conference agreement for S.
1082, which passed the Senate on May 9, and H.R.
2900, which passed the House on July 11. The
bill is focused primarily on FDA and contains
sections regarding user fees and drug safety
monitoring procedures. The bill also contains
the following provisions of interest to NIH: (1)
Title III would require NIH to expand research
on pediatric medical devices; (2) Title V would
reauthorize the Best Pharmaceuticals for
Children Act; (3) Title VIII would expand the
Clinicaltrials.gov registry to include mandatory
reporting of certain drug and device clinical
trials; and (4) Title XI would make technical
changes to Title IV of the PHS Act, where NIH
statutory authorities are located. The bill
would require the establishment within one year
of a “basic results” database that would contain
basic demographic information as well as
information on primary and secondary outcome
measures. The Secretary would be charged with
promulgating regulations within three years to
expand the results database to include adverse
event information, as well as additional summary
information regarding results.
Congress bypassed normal conference proceedings
in reconciling the House (H.R. 2900) and Senate
(S. 1082) versions of the clinical trials
registry legislation. Instead, Congress
negotiated a new, compromise bill: H.R. 3580.
Like previous versions of this legislation, H.R.
3580 expands the existing clinical trials
registry database to include all non-preliminary
clinical trials of drugs, devices, and
biologics, and it requires the inclusion of
results information. Unlike the previous bills,
H.R. 3580 includes provisions to prevent the
reporting of misleading or promotional results
information. It also establishes a rulemaking
process through which HHS will consider
inclusion of additional results information,
adverse events reporting, and submission
deadlines.
Jennifer A. Hobin, Science Policy Analyst,
FASEB’s Office of Public Affairs,
summarized the
legislation. In addition, the text of the bill
can be found here:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h3580eh.txt.pdf.
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NIH POLICY NEWS
Note: Kimberly Myers, a 2007
Presidential Management Fellow (PMF) from the
National Cancer Institute (NCI), is spending
three or four months working with Jon Retzlaff,
FASEB’s Director of Legislative Relations, to
expose her to the value, importance and role
that scientific societies bring to furthering
the mission of NIH. Ms. Myers has a Ph.D. from
Harvard in Virology and most recently, spent six
months in NCI's Office of Biorepositories and
Biospecimen Research, where she developed and
implemented a strategic communications,
education, and outreach plan targeted at
scientists, physicians, advocates, and patients.
Ms. Myers provided this background information
on this important area of research.
National Cancer Institute Publishes NCI
Best Practices for Biospecimen Resources
The availability of high quality, privacy
protected biospecimens is critical to supporting
development of new genomic- and proteomic-based
cancer interventions. Understanding the need to
unify and standardize practices around the use
of biospecimens and biospecimen resources, the
National Cancer Institute (NCI) published the
NCI Best Practices for Biospecimen Resources
(NCI Best Practices) in June 2007, following
significant due diligence and approval by the
National Cancer Advisory Board. This document
outlines best practices to optimize the quality
and accessibility of biospecimens to the
research community.
In order to encourage awareness and adoption of
the NCI Best Practices and seek feedback on
implementing and updating the Best Practices,
NCI initiated an education and outreach program
targeted at the scientific and advocacy
communities. Biospecimen Best Practices Forums
are intended to allow the NCI to engage,
educate, and receive input from the science and
advocacy communities and additional stakeholder
audiences. The first meeting was held on June
18th in Bethesda and included more than 150
attendees from the greater Washington D.C.
Metropolitan area. Future meetings will be help
in Boston on November 5, 2007, Chicago on
December 3, 2007, and Seattle on January 28,
2008.
Additional information about the NCI Best
Practices for Biospecimen Resources and NCI’s
Office of Biorepositories and Biospecimen
Research can be found at
http://biospecimens.cancer.gov.
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CONGRESSIONAL SCHEDULE
The House and Senate are in session. The Senate
has scheduled a one-week recess beginning
October 8, 2007. The House plans to remain in
session while the Senate is on recess that week.
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