FDA News Digest
July 24,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
--
FDA Approves Generic Versions of Osteoarthritis
Drug Mobic
-- Test Screens, Confirms Hepatitis B for Blood, Organ
Donations
-- New Type of Over-the-Counter Sunscreen Product
Approved
-- Novel Treatment OK'd for Rare Genetic Disease
Hunter Syndrome
-- New Plan Aims to Strengthen FDA Process
for Getting Scientific
Advice
-- FDA Supports IOM Report on Preventing Medication
Errors
-- Goldberger to Oversee Emerging and Pandemic Threat
Preparedness
» Latest
FDA Consumer Magazine Available
Online
»
Recalls/Safety
Alerts
» Recent
Speeches
» Congressional
Testimony
»
Upcoming Public
Meetings
» Question of
the Week
____________________________________________
NEWS
FDA Approves Generic Versions of
Osteoarthritis Drug Mobic
FDA has approved 13 generic versions of Mobic
(meloxicam), a nonsteroidal anti-inflammatory drug used to treat osteoarthritis.
Buying generic versions of drugs can result in significant savings for the
millions of Americans with osteoarthritis.
Test Screens, Confirms Hepatitis B for Blood, Organ
Donations
FDA has approved the Abbott PRISM HBsAg test system,
the first fully automated product that can both screen for and confirm the
presence of hepatitis B. The product is approved to test people who donate
blood, blood components, and organs. FDA says improvements in donor screening
"have helped make the nation's blood supply safer from infectious diseases than
it has been at any other time."
New Type of Over-the-Counter Sunscreen Product
Approved
FDA has approved Anthelios SX, a new sunscreen for sale
over the counter to prevent sunburn and protect against ultraviolet A and B
rays. The product contains ecamsule, an ingredient not previously marketed in
the United States. FDA advises consumers, in addition to using a sunscreen, to
limit time in the sun and wear
protective clothing to help diminish sun exposure.
Novel
Treatment OK'd for Rare Genetic Disease Hunter
Syndrome
FDA has approved Elaprase (idursulfase), the
first treatment for Hunter syndrome, a rare, inherited disease that can lead to
premature death. Usually emerging in children aged one to three
years, Hunter syndrome is diagnosed in one out of every 65,000 to
132,000 births in this country.
New Plan Aims to Strengthen FDA
Process for Getting Scientific Advice
FDA is taking steps to make its advisory
committee process more effective at providing the agency with
top-level, independent scientific advice while reassuring the public about
the integrity of the process. Included are guidelines designed
to provide greater clarity and transparency when disclosing
factors that could present the appearance of a conflict of
interest.
FDA Supports IOM Report on Preventing
Medication Errors
In a statement, FDA says a July 20 report by the
Institute of Medicine "provides a much-needed perspective on the frequency,
severity and preventable nature of medication errors." The agency adds that many
of the report's recommendations are supported by efforts already under way at
FDA.
Goldberger to Oversee Emerging and
Pandemic Threat Preparedness
FDA has appointed Mark Goldberger, M.D., to the new
position of medical director for emerging and pandemic threat preparedness. He
will oversee activities related to the development and evaluation of products
for emerging and pandemic threats. Goldberger brings to the job an extensive
regulatory background and public health experience with a wide range of
infectious diseases and emerging threats.
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.]
____________________________________________
Latest
FDA Consumer Magazine Available Online
The latest
issue of FDA Consumer includes articles on these
topics:
» Medicine use by older adults --
Working with health professionals to manage
medication.
» Artificial sweeteners --
A look at approved sugar substitutes.
» Cold medications -- Why you may have to show an ID now
to buy certain
decongestants.
» Improving vision -- Surgery and new
types of eyewear have upped
options.
» Upcoming flu season -- Revised
recommendations on who should get
shots.
» Quitting cigarettes -- New drug
targets parts of the brain that nicotine affects.
The issue is
online at http://www.fda.gov/fdac/406_toc.html.
Subscribe to the
print version of FDA Consumer:
http://www.fda.gov/fdac/orderform/fdap.html
________________________________________________________
RECALLS/SAFETY
ALERTS
Device Recall:
Certain lots of Medtronic Model 8731 Intrathecal Catheter and Model
8598 Intrathecal Catheter Distal Revision
Kit
Reason for recall: possible malfunction (tip may
dislodge)
Drug
Recall:
Ultravist Injection, 370 mgl/mL, 125mL, an intravenous x-ray
contrast agent
Reason for recall: presence of particulate matter in conjunction
with crystallization
Food Recalls:
Advance Brand Coconut Gel, 16 oz.
size
Reason for recall: undeclared
sulfites
Safety
Alert:
FDA is warning consumers and health care providers not to
use "bismacine" (also known as "chromacine"), an injectable product used to
treat Lyme disease. It contains high amounts of bismuth, a heavy metal
that is not approved in any form for injection. FDA is investigating one report
of a death and several reports of injury related to the
product.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01415.html
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.
Note: FDA has created a free
e-mail list that allows you to receive press releases about recalls of
FDA-regulated products. The list covers only Class 1
(life-threatening) recalls. To sign up, go to http://list.nih.gov/cgi-bin/wa?SUBED1=fda-recalls-l&A=1.
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.]
_____________________________________________
RECENT
SPEECHES
July 24
-- FDA Deputy Commissioner for Medical and Scientific
Affairs Scott Gottlieb, M.D., spoke at
the Center for Science in the Public
Interest Conference on Government Advisory
Committees
Subject: the advisory committee
process
http://www.fda.gov/oc/speeches/2006/conference0724.html
To
view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
___________________________________________________
CONGRESSIONAL
TESTIMONY
July 20 -- FDA Office of Generic Drugs Director
Gary Buehler, R.Ph., testified before the Senate Special Committee on
Aging.
Subject: improving access to generic
drugs
http://www.fda.gov/ola/2006/genericdrugs0720.html
To
view an archive of past testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html
_____________________________________________
UPCOMING PUBLIC MEETINGS
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
How can I participate in FDA's process for making its
rules?
In general, any citizen can submit comments on rules FDA proposes.
The agency announces rules in the Federal Register and
usually accepts comments for 60 days. The Federal Register
is available in many libraries or by going to the link below. FDA
urges consumers to participate in the rulemaking process. For more information
about submitting comments, call the FDA Dockets Management Branch at (301)
827-6860.
--
FDA Federal Register page: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
-- More on submitting comments to FDA:
http://www.fda.gov/opacom/backgrounders/voice.html
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