The EyeSmart™ public awareness campaign empowers Americans to take charge of their eye health. EyeSmart emphasizes the need for Americans to know their risk factors for eye diseases, infections and injuries, and how ophthalmologists can help prevent, diagnose and treat eye conditions.Visit: http://www.geteyesmart.org
The campaign is sponsored by the American Academy of Ophthalmology, the world's largest association of eye physicians and surgeons - Eye M.D.s. A key partner is EyeCare America, a public service program of the Foundation of the American Academy of Ophthalmology. In addition, more than 80 state, local and specialty ophthalmology societies are lending their support.
For Immediate Release: Nov. 5, 2009
Media Inquiries:
Michael Herndon, 301-796-4673, michael.herndon@fda.hhs.gov
Neil Gaffney, 202-720-9113, neil.gaffney@fsis.usda.gov
Consumer Inquiries: 888-INFO-FDA
A joint public meeting focused on improving the system for tracing of food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers was announced today by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA).
Recognizing the need to increase the speed and accuracy of traceback investigations and traceforward operations, both agencies are building on existing efforts by seeking public input that would help identify elements of effective food product tracing systems, identify current gaps in food product tracing, and suggest specific mechanisms for improvements.
The meeting is also intended to improve the ability of FDA and FSIS to use the information in such systems to respond to outbreaks more quickly by rapidly identifying the source of contamination during outbreaks of foodborne illness, and improving the ability of all persons in the supply chain to more quickly identify food that is (or potentially is) contaminated and remove it from the market during traceforward operations.
“This public meeting provides an opportunity for FDA to collaborate more closely with FSIS as well as with members of the food industry, many of whom have been making important innovations in food safety practices and technology, and all of whom bear primary responsibility for producing and marketing safe food,” said Michael R. Taylor, senior advisor to FDA’s Commissioner Margaret Hamburg, M.D.
“The Food Safety and Inspection Service is eager to work with FDA, public health officials, consumer advocates, and the food industry to improve our ability to trace products that may cause illness outbreaks,” said Jerold R. Mande, USDA’s Deputy Under Secretary for Food Safety. “The public can provide valuable input to strengthen our prevention, surveillance and response and recovery efforts, as outlined by the Administration’s Food Safety Working Group (http://www.foodsafetyworkinggroup.gov/).” In March 2009, President Obama announced the formation of the Food Safety Working Group, and in July, President Obama released Key Findings, which highlight steps that FSIS, FDA, and other Federal Agencies are taking to improve food safety.
Food can become contaminated at many different steps in the supply chain. Experience in conducting foodborne disease outbreak investigations suggests that improved product tracing abilities could help identify products associated with disease more quickly, get risky products off the market faster, and reduce the number of sicknesses associated with foodborne illness outbreaks.
The FDA and FSIS share authority for helping to ensure the safety of the nation’s food supply. Each agency investigates foodborne illness outbreaks and other foodborne risks associated with the products they regulate. These investigations, conducted in close cooperation with the U.S. Centers of Disease Control and Prevention and state and local health and agriculture departments, often involve tracing backward or forward in the supply chain the distribution of food products and ingredients associated with risk to consumer health.
A traceback investigation is an investigation to determine and document the distribution and production chain, and the source(s), of contaminated (and potentially contaminated) food, often in the context of an outbreak of foodborne illness. A traceforward operation is an operation to determine the distribution of contaminated (and potentially contaminated) food.
The meeting will be held Dec. 9 and 10 in Washington at the U.S. Department of Agriculture’s South Building in the Jefferson Auditorium, 1400 Independence Avenue, SW, Washington, D.C., 20250.
Those interested in attending the public meeting can pre-register online at: http://www.fsis.usda.gov/News_&_Events/Meetings_&_Events/index.asp. Online pre-registration is preferred, but pre-registration can also be done by faxing registration information (including name, title, firm name, address, telephone number, e-mail address and fax number) to 1-877-366-3322 by Dec. 2. Pre-registration is strongly encouraged for all persons who wish to attend the meeting, regardless of whether they also wish to request an opportunity to make oral comments at the meeting on issues and questions described in the Federal Register notice.
For more information on food safety visit: www.foodsafety.gov
For Immediate Release: Nov. 5, 2009
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.
Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.
Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death.
In the case of Stiff Nights, following a consumer complaint, the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.
The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.
"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”
The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm
The FDA remains committed to stopping the illegal marketing of unapproved drugs and will continue to protect the public with vigorous law enforcement and criminal prosecution of violators.
On November 12th & 13th the FDA will hold public hearings to assess the role of social media relative to the FDA's charter. Sermo has been asked to provide the FDA with insight on this question. This is an important opportunity for this community to help define what its role should be relative to the FDA and what role the FDA should play in this medium. Key issues that the FDA wants to address are:
How many people at the FDA really understand social media? I still meet people on a regular basis who don't know about Twitter. What's Twitter? They hear the name on the radio or television, but they have no concept of microblogging.
Mark your calendars for November 12 and 13 and stay tuned...
November is American Diabetes Month®—a time to shine a spotlight on a serious disease that leads to potentially life-threatening complications such as heart disease, stroke, kidney disease, blindness, and amputation.So, what can you do?
This year, we need to take a bolder, more audacious approach to American Diabetes Month.
Consider that:
•24 million children and adults in the United States live with diabetes
•57 million Americans are at risk for type 2 diabetes
•1 out of every 3 children born today will face a future with diabetes if current trends continue
A preliminary breakdown of the results found a “significantly increased risk” of some brain tumours “related to use of mobile phones for a period of 10 years or more” in some studies.Now, keep in mind that phones have evolved dramatically and that older analog phones emitted higher levels of compared to modern digital phones (although smartphones and high bandwidth data plans are a different story).
For Immediate Release: Nov. 4, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.
“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries,” said FDA Commissioner Margaret A. Hamburg, M.D.
Millions of people are harmed every year from inappropriate medication use. Many injuries occur as a result of incomplete access to information about a drug, a patient, or the patient’s condition.
Other preventable sources of harm include unintentional misuse of medications, medication abuse, and attempts at self harm. Unintended exposure to prescription medications such as opioid drugs can cause harm, even death, in a single dose, if taken by someone other than the patient who was prescribed the medication.
“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”
More detailed information on the new program was contained in a report, titled, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report was released by Drs. Hamburg and Woodcock at FDA’s annual Science Writers Symposium at the agency’s White Oak Campus in Silver Spring, Md.
As outlined in the report, the FDA intends to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm. A list of specific problems, cross-sector interventions for reducing harm from these problems, and the metrics for success will be developed.
The report highlights several risk-reduction projects that may benefit from Safe Use collaborations, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.
To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback as the candidate list is being developed and will open a public docket to receive comments on the report and proposed candidate cases.
The agency also today made public new FDA guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons.
The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register today.
Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.
"This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”
For more information: http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm
John Kansky, MS, MBAHis presentation was titled, "ARRA HITECH and Health Information Exchange: Opportunities and Pitfalls"
VP -- Business Development, Indiana Health Information Exchange
Indianapolis, IN
To promote a more effective marketplace, greater competition, and increased choice through accessibility to accurate information on healthcare costs, quality, and outcomes, the Office of the National Coordinator (ONC) is advancing the NHIN as a “network of networks” which will connect diverse entities that need to exchange health information, such as state and regional health information exchanges (HIEs), integrated delivery systems, health plans that provide care, personally controlled health records, Federal agencies, and other networks as well as the systems to which they, in turn, connect.Not familiar with all the acronyms?
Mr. Kansky is Vice President for Business Development for the Indiana Health Information Exchange. He has worked in the healthcare technology field for 22 years with experience in healthcare information technology, health information exchange, and biomedical technology. He has served organizations in the role of Chief Information Officer, Director of Information Systems, and Director of Clinical Engineering and has spoken nationally on healthcare IT, health information exchange, and HIPAA compliance. Mr. Kansky has a BS in Electrical Engineering, an MS in Biomedical Engineering and an MBA. He currently serves on the Health Information and Management System Society (HIMSS) Healthcare Information Exchange Steering Committee and the board of the Indiana Chapter of HIMSS.
For Immediate Release: Nov. 2, 2009
Media Inquiries: Raymond Formanek Jr., 301-796-4677; raymond.formanek@fda.hhs.gov
Other Inquiries: Afia Asamoah, 301-796-4625; afia.asamoah@fda.hhs.gov
The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009.
The meeting is scheduled for 9 a.m. to 3 p.m. at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza, S.W., Washington, D.C., 20594. Directions to the NTSB Conference Center are at http://www.ntsb.gov/events/newlocation.htm
The purpose of the meeting is to receive detailed comments on the following three specific issues related to transparency at the FDA:
The FDA formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.” The Task Force is developing recommendations for making useful and understandable information about FDA activities and decision-making more readily available in a timely manner and in a user-friendly format, while appropriately protecting confidential information.
The task force held its first daylong meeting in June 2009.
Those interested can submit electronic or written comments by Nov. 6, 2009. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
There is no fee to register for the public meeting. Registration on the day of the meeting will be permitted on a space-available basis, beginning at 7:30 a.m. Those who cannot attend the meeting can view it via live Webcast at http://www.capitolconnection.net/capcon/fda/110309/FDAlive.htm
The Webcast will be archived on the FDA Transparency Task Force page
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm
A media room with dial-up Internet access will be provided. Please note there is no wireless service within the NTSB Conference Center.
For more information
Hypothetical Case Studies for November 3 Public Meeting on Transparency
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm187750.htm
November 3 Public Meeting on Transparency
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm188633.htm
With HealthVault, international patients who receive treatment at Bumrungrad will be able to access and share their medical records via the Web once they're back home, promoting continuity of care. The records are available free to Bumrungrad's approximately 420,000 international patients as well as to those living locally.Sounds like some exciting developments in the international PHR space. Since we're all connected by the Internet, it should be relatively easy to access health records from anywhere in the world. I'm sure we'll be hearing some interesting things about Google Health in the near future as they make inroads in the PHR space.
Bumrungrad has 1.5 million patients, and about 45,000 of those annually are Americans who travel to Thailand for healthcare services that are too expensive in the U.S., or aren't readily available to them if they're living outside the U.S. as expatriates.
