FDA News Digest
July 17,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- FDA Approves Once-a-Day Combination Drug to Treat
HIV
-- New Site Teaches
Children About Safe Use of OTC
Drugs
-- FDA Offers Glimpse at Important Milestones
in Its
History
»
Recalls/Safety
Alerts
» Congressional
Testimony
»
Upcoming Public
Meetings
» Question of
the Week
____________________________________________
NEWS
FDA Approves Once-a-Day Combination Drug to
Treat HIV
FDA has approved Atripla, a once-daily tablet to treat
HIV infection that combines the
active ingredients of the drugs Sustiva, Emtriva, and Viread. The new drug helps
simplify the treatment regimen and can improve the ability of patients to adhere
to a dosing schedule. The drug was developed under an unprecedented joint
venture between three pharmaceutical
companies.
New Site Teaches
Children About
Safe Use of OTC
Drugs
"Medicines in My Home" is a new Web site that aims to
help children -- especially 11- and 12-year-olds -- understand the safe use of
over-the-counter medicines. The site is designed to be used as part of a
classroom curriculum, but it also can serve as an information source independent
of the classroom. FDA developed the site with the Montgomery County (Md.) Public
School System and the National Council on Patient Information and
Education.
FDA Offers Glimpse at Important Milestones
in Its History
As part of FDA's observance of its first 100 years, the
agency has created "This Week in FDA History," a Web page that spotlights a
different FDA milestone each week. The page also describes how each historical
item relates to current agency operations and offers links to further
information for those who want to probe
deeper.
To
view an archive of past FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news releases, go
to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What
is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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RECALLS/SAFETY
ALERTS
Device Recall:
Disetronic D-TRONplus Power Packs (which power the D-TRONplus
insulin pumps)
Reason for recall: potential for
malfunction
Drug
Recall:
One
lot of Azathioprine tablets, 50 mg. size, used to prevent rejection in kidney
transplant patients and to treat severe rheumatoid
arthritis
Reason for recall: tablets of another drug, Methotrexate, were
found in a bottle of Azathioprine
Food Recalls:
47,300 bags of Harry & David Hot Chili Pepper Tortilla
Chips
Reason for recall: undeclared
milk
For a
list of recalls, market withdrawals, and safety alerts involving
FDA-regulated
products
from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go
to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.
[What is
an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_____________________________________________
CONGRESSIONAL
TESTIMONY
July 11 -- FDA Associate Commissioner for Policy and
Planning Randall W. Lutter, Ph.D., testified before the House Subcommittee on Criminal
Justice, Drug Policy, and Human Resources.
Subject: pharmaceutical supply chain security
http://www.fda.gov/ola/2006/counterfeit0711.html
To
view an archive of past testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html
_____________________________________________
UPCOMING PUBLIC MEETINGS
Note:
FDA canceled the July 14 meeting of the Blood Products Advisory
Committee, which had been scheduled to discuss a proposed clinical trial by the
U.S. Navy of a blood substitute product. The agency is working to
reschedule a meeting where information can be shared with the
public.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01410.html
Aug.
23-24 -- Industry Exchange
Workshop on FDA Clinical Trial
Requirements
Under discussion: industry and FDA
perspectives on proper conduct of FDA-regulated clinical
trials
Location: Brooklyn Park,
Minn.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8896.htm
For a list of FDA meetings, seminars, and other
public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
__________________________________________________
QUESTION OF THE WEEK
Has the United States made progress in
reducing dioxins in the
environment?
Yes. U.S. environmental
dioxin levels have declined
for the last 30 years due to reductions in manmade sources. The combined
efforts of federal and state
governments, along with
industry, have helped reduce
known and quantifiable industrial emissions of dioxin in the
United
States by more than 90 percent from 1987 levels. However, dioxins
break down so slowly that some of the dioxins from past releases will still be
in the environment many years from now. Dioxins that remain in the environment
from past releases are sometimes called "reservoir sources" of dioxins. Because
of natural processes, dioxin levels in the environment will never go to
zero.
Based on
recent measurements in a few states, it appears that levels in our bodies are
going down too. Federal agencies are continuing to monitor to see if these
trends continue.
For more on dioxins and the environment, see:
http://www.cfsan.fda.gov/~lrd/dioxinqa.html.
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