CPSC/EPA/HUD/CDC/ATSDR Press Statement on Initial Chinese Drywall Studies
Since the early spring, the federal government has dedicated significant resources to helping families affected by the drywall issue in their homes. The government has been and continues to be committed to providing answers and solutions to these homeowners. The U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA), U.S. Department of Housing and Urban Development (HUD), Centers for Disease Control and Prevention (CDC), Agency for Toxic Substance and Disease Registry (ATSDR), and numerous state departments of health have been working together to investigate and analyze how Chinese made drywall entered into the country, where it was used, what is in it, and what impact it may have on human health and corrosion of electrical and fire safety components.
This is a complicated problem, and we have several studies and other activities underway to help bring the best possible science to bear. The first sets of data released today start to explain differences between Chinese and non-Chinese drywall, but more remains to be learned. We are sharing what we know at this point and are outlining the next steps as we continue to work to answer homeowners’ questions about what is causing the effects reported and observed.
Initial Results of 3 Studies of Chinese and Non-Chinese made drywall
The studies summarized below have discovered certain differences between Chinese and non-Chinese drywall. Further studies must be completed, however, to determine the nexus between the drywall and the reported health and corrosion issues. Preliminarily, the studies show:
1. Elemental and Chemical Testing: Federal scientists analyzed pieces of drywall to discover what chemicals it contains. Some differences were found between the Chinese and non-Chinese drywall. Of the samples tested, the study shows the presence of elemental sulfur in Chinese but not in non-Chinese drywall, and it also shows higher concentrations of strontium in Chinese drywall than in non-Chinese drywall. Testing conducted over the summer by federal and state agency radiation laboratories found no radiation safety risk to families in homes built with manufactured drywall. The strontium found in this drywall does not pose a radiological risk.
2. Chamber Studies: The second set of tests is being conducted by the nationally-respected Lawrence Berkeley National Laboratory (LBL), which is carrying out chamber testing on emissions from samples of Chinese and non-Chinese drywall into the air. These tests are still underway, but we are sharing preliminary findings. Early results show that Chinese drywall emits volatile sulfur compounds at a higher rate than the U.S. made drywall. More tests and analyses are underway at LBL to determine the specific chemical compounds that are being emitted.
3. Indoor Air Studies: In analyzing indoor air results in 10 homes in Florida and Louisiana, federal and Florida Department of Health researchers were looking for hydrogen sulfide, carbon disulfide and carbonyl sulfide, which have been suspected of causing "rotten egg" smells and sulfur-like corrosion of copper and other metals in the homes.
The study found that sulfur gases were either not present or were present in only limited or occasional concentrations inside the homes, and only when outdoor levels of sulfur compounds in the air were elevated.
The indoor air study did lead to a preliminary finding of detectable concentrations of two known irritant compounds, called acetaldehyde and formaldehyde. These irritant compounds were detected in homes both with and without Chinese drywall, and at concentrations that could worsen conditions such as asthma in sensitive populations, when air conditioners were not working or turned off. The levels of formaldehyde were not unusual for new homes and were higher in homes where air conditioners were not working or turned off.
Although formaldehyde was found, when the air conditioning was turned on, it was not at levels that have been found to cause health symptoms.
The initial indoor air studies were conducted on a small and limited sample of homes in Florida and Louisiana to identify and measure contaminants and to inform the development of a federal and state indoor air testing protocol. The studies released today, and the additional study reports scheduled for release next month, once completed, will collectively help to develop a final standard federal and state protocol for testing homes and to identify a nexus between the presence of Chinese drywall and the reported health and corrosive issues.
Next Steps
Although we know more now than we did just a few weeks ago, we are continuing to learn as much as we can in order to respond to homeowners’ concerns with the best scientific information. We expect to have more information to share in late November. At that time, we will have more information from CPSC’s 50-home air sampling project conducted through Environmental Health and Engineering (EH&E), a nationally-respected environmental testing firm based in Massachusetts. The report of our 50-home indoor air study will include additional testing results, including the exposure of small copper and silver metal strips. These strips are being used to help determine if there is a relationship between homes with Chinese drywall and corrosion of metal components in those homes. This study is also looking for certain sulfur gases at lower levels than could be detected in the initial studies.
Also in November, we expect to release a preliminary engineering analysis of potential electrical and fire safety issues related to corrosion.
All of the federal and state partners will continue to work on behalf of the families affected by this Chinese drywall issue. We are committed to providing answers to homeowners. As new information becomes available, we will share it as quickly as possible.
The federal interagency working group is actively talking to Congressional and White House officials to consider legislative and other means of helping families affected by and struggling with this issue.
Recommendations to Affected Homeowners
To date, CPSC has received nearly 1900 reports from 30 states, the District of Columbia and Puerto Rico from consumers and homeowners concerned about problem drywall in their home. Homeowners who believe they may be affected by this issue should immediately report the problem to CPSC by calling 800-638-2772 or logging on to www.CPSC.gov.
Federal and state health experts suggest these steps to improve indoor air quality and to reduce exposure to substances that can cause health concerns:
Open windows as much as possible to let in fresh air.
Keep the temperature inside homes at the lowest comfortable setting.
Run the air conditioner or dehumidifier.
Also, spend as much time outdoors in fresh air as possible.
Do not smoke, and especially do not smoke indoors. Cigarette smoke contains, among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to www.DrywallResponse.gov
Friday, October 30, 2009
STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES
CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356 WWW.USDOJ.GOV/USAO/MA
E-MAIL: USAMA.MEDIA@USDOJ.GOV
STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES
Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries.
Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”). Acting United States Attorney Michael K. Loucks; Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration - Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General - Office of Investigations; and Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division, announced today that STRYKER BIOTECH, LLC, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER were charged in an Indictment with five counts of wire fraud and one count of conspiracy. STRYKER BIOTECH, DAVID ARD and JEFF WHITAKER were also charged with misbranding. In addition, STRYKER BIOTECH and MARK PHILIP were charged with making false statements to the FDA.
The Indictment alleges that all of the defendants participated in an illegal marketing scheme to promote medical devices used during invasive surgeries, and in doing so having defrauded medical professionals and the FDA. In particular, the defendants are alleged to have promoted devices known as OP-1 Implant and OP-1 Putty. These devices were used to stimulate bone growth in long bones and the spine. These devices were approved by the FDA only pursuant to a highly restrictive Humanitarian Device Exemption (“HDE”).
One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit. The Indictment charges that the defendants promoted the use of these devices in a manner that was different from its FDA approved use; namely they promoted a combination of the devices with a bone void filler, called Calstrux, and in furtherance of that promotion provided “recipes” to surgeons, medical technicians and others as to how to mix the OP-1 products with Calstrux. It is alleged that some of these untested “recipes” called for medical personnel to mold the combined product into “cigars,” “tootsie rolls” or “vienna sausages.”
The Indictment charges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA. It is alleged that the reason the defendants promoted the OP-1 products in a mixture with Calstrux was because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.
The Indictment also charges that defendants STRYKER BIOTECH, LLC and MARK PHILIP made false statements to the FDA about the number of patients that STRYKER BIOTECH was treating on an annual basis with OP-1 Putty.
If convicted of the wire fraud, conspiracy, misbranding or false statements charges, STRYKER BIOTECH faces fines of the greater of $500,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the wire fraud charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 20 years imprisonment, to be followed by 3 years of supervised release and a fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count. If convicted on the conspiracy charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 5 years imprisonment, to be followed by 3 years of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the misbranding charges, DAVID ARD and JEFF WHITAKER each face up to 3 years imprisonment, to be followed by 1 year of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense on each charge. If convicted on the false statement charge, MARK PHILIP faces up to 5 years imprisonment, to be followed by 3 years supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense.
The case was investigated by the Food & Drug Administration - Office of Criminal Investigations, the Department of Health and Human Services - Office of Inspector General and the Federal Bureau of Investigation. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Loucks’ Health Care Fraud Unit.
The details contained in the Indictment are allegations. The defendants are presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
PHONE: (617)748-3356 WWW.USDOJ.GOV/USAO/MA
E-MAIL: USAMA.MEDIA@USDOJ.GOV
STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES
Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries.
Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”). Acting United States Attorney Michael K. Loucks; Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration - Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General - Office of Investigations; and Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division, announced today that STRYKER BIOTECH, LLC, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER were charged in an Indictment with five counts of wire fraud and one count of conspiracy. STRYKER BIOTECH, DAVID ARD and JEFF WHITAKER were also charged with misbranding. In addition, STRYKER BIOTECH and MARK PHILIP were charged with making false statements to the FDA.
The Indictment alleges that all of the defendants participated in an illegal marketing scheme to promote medical devices used during invasive surgeries, and in doing so having defrauded medical professionals and the FDA. In particular, the defendants are alleged to have promoted devices known as OP-1 Implant and OP-1 Putty. These devices were used to stimulate bone growth in long bones and the spine. These devices were approved by the FDA only pursuant to a highly restrictive Humanitarian Device Exemption (“HDE”).
One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit. The Indictment charges that the defendants promoted the use of these devices in a manner that was different from its FDA approved use; namely they promoted a combination of the devices with a bone void filler, called Calstrux, and in furtherance of that promotion provided “recipes” to surgeons, medical technicians and others as to how to mix the OP-1 products with Calstrux. It is alleged that some of these untested “recipes” called for medical personnel to mold the combined product into “cigars,” “tootsie rolls” or “vienna sausages.”
The Indictment charges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA. It is alleged that the reason the defendants promoted the OP-1 products in a mixture with Calstrux was because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.
The Indictment also charges that defendants STRYKER BIOTECH, LLC and MARK PHILIP made false statements to the FDA about the number of patients that STRYKER BIOTECH was treating on an annual basis with OP-1 Putty.
If convicted of the wire fraud, conspiracy, misbranding or false statements charges, STRYKER BIOTECH faces fines of the greater of $500,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the wire fraud charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 20 years imprisonment, to be followed by 3 years of supervised release and a fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count. If convicted on the conspiracy charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 5 years imprisonment, to be followed by 3 years of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the misbranding charges, DAVID ARD and JEFF WHITAKER each face up to 3 years imprisonment, to be followed by 1 year of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense on each charge. If convicted on the false statement charge, MARK PHILIP faces up to 5 years imprisonment, to be followed by 3 years supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense.
The case was investigated by the Food & Drug Administration - Office of Criminal Investigations, the Department of Health and Human Services - Office of Inspector General and the Federal Bureau of Investigation. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Loucks’ Health Care Fraud Unit.
The details contained in the Indictment are allegations. The defendants are presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:
To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.
(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)
For more information
FDA Warning Letter to Procter & Gamblehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm
FDA Drug Safety Initiativehttp://www.fda.gov/cder/drugSafety.htm
Consumer Inquiries: 888-INFO-FDA
FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:
To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.
(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)
For more information
FDA Warning Letter to Procter & Gamblehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm
FDA Drug Safety Initiativehttp://www.fda.gov/cder/drugSafety.htm
Wednesday, October 28, 2009
Basic Information on H1N1 Preventative Measures
Seriously....what's a person to do??? Get the shot...don't get theshot.....get the shot.....don't get the shot! Geeze enuf already. So confusing! Who should we believe is telling the truth?
This is great simple information ... Take heed and avoid getting sick.....
Dr. Vinay Goyal is an MBBS,DRM,DNB (Intensivist and Thyroid specialist),having clinical experience of over 20 years. He has worked ininstitutions like Hinduja Hospital,Bombay Hospital, Saifee Hospital,Tata Memorial, etc.
Presently, he is heading our Nuclear MedicineDepartment and Thyroid clinic at Riddhivinayak Cardiac and CriticalCentre, Malad (W).The following message is given by him; I feel it makes a lot of senseand is important for all to know
The only portals of entry are the nostrils and mouth/throat. In a global epidemic of this nature, it's almost impossible not coming intocontact with H1N1 in spite of all precautions.
Contact with H1N1 is not so much of a problem as proliferation is. While you are still healthy and not showing any symptoms of H1N1infection, in order to prevent proliferation, aggravation of symptoms and development of secondary infections, some very simple steps, not fully highlighted in most official communications, can be practiced(instead of focusing on how to stock N95 or Tamiflu):
1. Frequent hand-washing (well highlighted in all officialcommunications).
2. "Hands-off-the-face" approach. Resist all temptations to touch anypart of face until you have washed your hands.
3. *Gargle twice a day with warm salt water (use Listerine if you don'ttrust salt). *H1N1 takes 2-3 days after initial infection in thethroat/nasal cavity to proliferate and show characteristic symptoms.Simple gargling prevents proliferation. In a way, gargling with saltwater has the same effect on a healthy individual that Tamiflu has on aninfected one. Don't underestimate this simple, inexpensive and powerfulpreventative method.
4. Similar to 3 above, *clean your nostrils at least once every daywith warm salt water. Not everybody may be good at using a Neti pot,but blowing the nose hard once a day and swabbing both nostrils withcotton swabs dipped in warm salt water is very effective in bringingdown viral population.*
5. Boost your natural immunity with foods that are rich in Vitamin C.*If you have to supplement with Vitamin C tablets, make sure that italso has Zinc to boost absorption.
6. Drink as much of warm liquids (tea, coffee, etc) as you can.*Drinking warm liquids has the same effect as gargling, but in thereverse direction. They wash off proliferating viruses from the throatinto the stomach where they cannot survive, proliferate or do any harm.
I suggest you pass this on to your entire e-list; you never know who might pay attention to it - and STAY ALIVE because of it
- Neti pots and sinus rinse kits are available at the drug store andrelatively inexpensive under $15.
This is great simple information ... Take heed and avoid getting sick.....
Dr. Vinay Goyal is an MBBS,DRM,DNB (Intensivist and Thyroid specialist),having clinical experience of over 20 years. He has worked ininstitutions like Hinduja Hospital,Bombay Hospital, Saifee Hospital,Tata Memorial, etc.
Presently, he is heading our Nuclear MedicineDepartment and Thyroid clinic at Riddhivinayak Cardiac and CriticalCentre, Malad (W).The following message is given by him; I feel it makes a lot of senseand is important for all to know
The only portals of entry are the nostrils and mouth/throat. In a global epidemic of this nature, it's almost impossible not coming intocontact with H1N1 in spite of all precautions.
Contact with H1N1 is not so much of a problem as proliferation is. While you are still healthy and not showing any symptoms of H1N1infection, in order to prevent proliferation, aggravation of symptoms and development of secondary infections, some very simple steps, not fully highlighted in most official communications, can be practiced(instead of focusing on how to stock N95 or Tamiflu):
1. Frequent hand-washing (well highlighted in all officialcommunications).
2. "Hands-off-the-face" approach. Resist all temptations to touch anypart of face until you have washed your hands.
3. *Gargle twice a day with warm salt water (use Listerine if you don'ttrust salt). *H1N1 takes 2-3 days after initial infection in thethroat/nasal cavity to proliferate and show characteristic symptoms.Simple gargling prevents proliferation. In a way, gargling with saltwater has the same effect on a healthy individual that Tamiflu has on aninfected one. Don't underestimate this simple, inexpensive and powerfulpreventative method.
4. Similar to 3 above, *clean your nostrils at least once every daywith warm salt water. Not everybody may be good at using a Neti pot,but blowing the nose hard once a day and swabbing both nostrils withcotton swabs dipped in warm salt water is very effective in bringingdown viral population.*
5. Boost your natural immunity with foods that are rich in Vitamin C.*If you have to supplement with Vitamin C tablets, make sure that italso has Zinc to boost absorption.
6. Drink as much of warm liquids (tea, coffee, etc) as you can.*Drinking warm liquids has the same effect as gargling, but in thereverse direction. They wash off proliferating viruses from the throatinto the stomach where they cannot survive, proliferate or do any harm.
I suggest you pass this on to your entire e-list; you never know who might pay attention to it - and STAY ALIVE because of it
- Neti pots and sinus rinse kits are available at the drug store andrelatively inexpensive under $15.
Thursday, October 22, 2009
CPSC Announces ANPR for Recreational Off-Highway Vehicles (ROVs) to Address Rising Death Toll
CPSC Announces ANPR for Recreational Off-Highway Vehicles (ROVs) to Address Rising Death Toll
WASHINGTON, D.C. - Furthering its commitment to improve the safety of Recreational Off-Highway Vehicles (ROVs) and reduce the number of deaths and serious injuries nationwide, the U.S. Consumer Product Safety Commission voted to publish an advance notice of proposed rulemaking (ANPR) to address safety hazards associated with vehicle ROVs.
CPSC staff’s preliminary evaluations indicated that the vehicles may exhibit inadequate lateral stability, undesirable steering characteristics, and inadequate occupant protection during a rollover crash. The staff reviewed the Recreational Off-Highway Vehicle Association (ROHVA) draft proposed American National Standard for Recreational Off-Highway Vehicles, ANSI/ROHVA 1-200X and found preliminarily that it does not adequately address the deaths and injuries associated with ROV rollovers and collisions.
The ANPR invites written comments from the public regarding the risks of injury associated with ROVs and ways in which these risks could be addressed. Following publication of the ANPR, the public will have 60 days to provide comments to the Commission. Comments can be submitted at www.regulations.gov
WASHINGTON, D.C. - Furthering its commitment to improve the safety of Recreational Off-Highway Vehicles (ROVs) and reduce the number of deaths and serious injuries nationwide, the U.S. Consumer Product Safety Commission voted to publish an advance notice of proposed rulemaking (ANPR) to address safety hazards associated with vehicle ROVs.
CPSC staff’s preliminary evaluations indicated that the vehicles may exhibit inadequate lateral stability, undesirable steering characteristics, and inadequate occupant protection during a rollover crash. The staff reviewed the Recreational Off-Highway Vehicle Association (ROHVA) draft proposed American National Standard for Recreational Off-Highway Vehicles, ANSI/ROHVA 1-200X and found preliminarily that it does not adequately address the deaths and injuries associated with ROV rollovers and collisions.
The ANPR invites written comments from the public regarding the risks of injury associated with ROVs and ways in which these risks could be addressed. Following publication of the ANPR, the public will have 60 days to provide comments to the Commission. Comments can be submitted at www.regulations.gov
Friday, October 16, 2009
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
Media Inquiries: Christopher Kelly, 301-796-4676 christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.
These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.
“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”
Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.
Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.
The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.
The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).
Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.
The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products
Consumer Inquiries: 888-INFO-FDA
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.
These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.
“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”
Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.
Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.
The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.
The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).
Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.
The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products
Wednesday, October 14, 2009
2 indicted for sending more than 15,000 misbranded drugs to customers
United States Department of Justice United States Attorney’s Office District of Minnesota
David Anderson, Public Affairs Specialist
(612) 664-5684; cell: (612) 730-2251
WWW.USDOJ.GOV/USAO/MN
2 indicted for sending more than 15,000 misbranded drugs to customers
A federal grand jury has returned an indictment against two Twin Cities men for allegedly releasing more than 15,000 misbranded drugs to customers.
In an indictment filed with the court earlier today, Nicholas David Lundsten, 26, Spring Lake Park, and Patrick James Barron, 29, Fridley, were charged with one count of introduction into interstate commerce of misbranded drugs and one count of importation of non-narcotic Schedule IV controlled substances. The indictment alleges the defendants caused the introduction and delivery of 3,600 pills falsely labeled as Cialis, 1,582 pills falsely labeled as Propetia, 10,419 pills falsely labeled as Viagra; and 340 pills falsely labeled as Levitra. In fact, all of the drugs contained the active pharmaceutical ingredients of the drugs they imitated but were not the authentic product as labeled and were not made by the respective manufacturer. The indictment alleges this occurred from an unknown date through December 2008.
The indictment also alleges the defendants knowingly imported into the United States 39,288 pills purporting to be Xanax, a sedative that contains Alprazolam, a non-narcotic Schedule IV controlled substance, and 27,336 pills purporting to be Phentermine, a weight-loss drug, that contained Sibutramine, another non-narcotic Schedule IV controlled substance, rather than Phentermine.
If convicted, the introduction count carries a maximum penalty of one year in prison, and the importation count carries a maximum penalty of five years in prison. All sentences are determined by a federal district court judge.
This case is the result of an investigation by the U.S. Food and Drug Administration-Office of Criminal Investigation, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection. It is being prosecuted by Assistant U.S. Attorney David J. MacLaughlin.
An indictment is a determination by a grand jury that there is probable cause to believe that offenses have been committed by a defendant. A defendant, of course, is presumed innocent until he or she pleads guilty or is proven guilty at trial.
David Anderson, Public Affairs Specialist
(612) 664-5684; cell: (612) 730-2251
WWW.USDOJ.GOV/USAO/MN
2 indicted for sending more than 15,000 misbranded drugs to customers
A federal grand jury has returned an indictment against two Twin Cities men for allegedly releasing more than 15,000 misbranded drugs to customers.
In an indictment filed with the court earlier today, Nicholas David Lundsten, 26, Spring Lake Park, and Patrick James Barron, 29, Fridley, were charged with one count of introduction into interstate commerce of misbranded drugs and one count of importation of non-narcotic Schedule IV controlled substances. The indictment alleges the defendants caused the introduction and delivery of 3,600 pills falsely labeled as Cialis, 1,582 pills falsely labeled as Propetia, 10,419 pills falsely labeled as Viagra; and 340 pills falsely labeled as Levitra. In fact, all of the drugs contained the active pharmaceutical ingredients of the drugs they imitated but were not the authentic product as labeled and were not made by the respective manufacturer. The indictment alleges this occurred from an unknown date through December 2008.
The indictment also alleges the defendants knowingly imported into the United States 39,288 pills purporting to be Xanax, a sedative that contains Alprazolam, a non-narcotic Schedule IV controlled substance, and 27,336 pills purporting to be Phentermine, a weight-loss drug, that contained Sibutramine, another non-narcotic Schedule IV controlled substance, rather than Phentermine.
If convicted, the introduction count carries a maximum penalty of one year in prison, and the importation count carries a maximum penalty of five years in prison. All sentences are determined by a federal district court judge.
This case is the result of an investigation by the U.S. Food and Drug Administration-Office of Criminal Investigation, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection. It is being prosecuted by Assistant U.S. Attorney David J. MacLaughlin.
An indictment is a determination by a grand jury that there is probable cause to believe that offenses have been committed by a defendant. A defendant, of course, is presumed innocent until he or she pleads guilty or is proven guilty at trial.
Thursday, October 8, 2009
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Media Inquiries: Stephanie Kwisnek, 301-796-4737, Stephanie.Kwisnek@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Company allegedly failed to correct violations
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.
The complaint also names Rel's Vice President, Peder Scott Sorensen, and two managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares, processes, and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts, and gas stations in Nevada and California.
The government's complaint, filed this week in the U.S. District Court, Northern District of California, alleges that Rel's has an extensive history of operating under insanitary conditions. The complaint states that Rel's has produced and distributed ready-to-eat sandwiches contaminated with Listeria monocytogenes (L. mono). Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems, and pregnant women may suffer miscarriages or stillbirths as a result of the infection.
The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.
“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”
No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.Consumers can report problems with FDA-regulated products to their district office consumer complaint
coordinator.
Consumer Inquiries: 1-888-INFO-FDA
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Company allegedly failed to correct violations
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.
The complaint also names Rel's Vice President, Peder Scott Sorensen, and two managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares, processes, and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts, and gas stations in Nevada and California.
The government's complaint, filed this week in the U.S. District Court, Northern District of California, alleges that Rel's has an extensive history of operating under insanitary conditions. The complaint states that Rel's has produced and distributed ready-to-eat sandwiches contaminated with Listeria monocytogenes (L. mono). Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems, and pregnant women may suffer miscarriages or stillbirths as a result of the infection.
The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.
“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”
No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.Consumers can report problems with FDA-regulated products to their district office consumer complaint
coordinator.
Wednesday, October 7, 2009
Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours
Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours
2009-161
OTTAWA – Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.
Sleep aid drugs are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. The new labelling describes reports of complex sleep-related behaviours that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.
The new labelling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.
Patients and people close to them are encouraged to be aware of these types of sleep-related behaviours. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviours, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.
The sleep-aid medications with potential risk of complex sleep-related behaviours include flurazepam, nitrazepam, temazepam, triazolam, zopiclone, zolpidem, and zaleplon. While authorized by Health Canada, zolpidem and zaleplon are not currently sold in Canada but may become available in the future.
Health Canada has worked with manufacturers to update the labelling of the following brand-name sleep aid drugs:
•Dalmane, Som Pam (flurazepam)
•Mogadon, Nitrazadon (nitrazepam)
•Restoril (temazepam)
•Apo-Triazo (triazolam)
•Imovane, Rhovane (zopiclone)
The updated Canadian product monographs for these drugs can be found by search of the Drug Product Database on the Health Canada website. The product monographs for the generic formulations (see the following list of Authorized sleep-aid medications in Canada for a list of generic sleep-aid drugs) will be updated in the future; patients taking generic sleep-aid drugs may at this time consult the Product Monographs of the brand-name products for the updated information.
Patients should typically not take sleep aid drugs for more than 7 to 10 days in a row. The drugs affected by this labelling change are all available by prescription only in Canada.
Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.
Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
•Report online at the MedEffect™ Canada section of the Health Canada website
•Call toll-free at 1-866-234-2345
•Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701C Ottawa, ON K1A 0K9
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
2009-161
OTTAWA – Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.
Sleep aid drugs are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. The new labelling describes reports of complex sleep-related behaviours that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.
The new labelling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.
Patients and people close to them are encouraged to be aware of these types of sleep-related behaviours. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviours, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.
The sleep-aid medications with potential risk of complex sleep-related behaviours include flurazepam, nitrazepam, temazepam, triazolam, zopiclone, zolpidem, and zaleplon. While authorized by Health Canada, zolpidem and zaleplon are not currently sold in Canada but may become available in the future.
Health Canada has worked with manufacturers to update the labelling of the following brand-name sleep aid drugs:
•Dalmane, Som Pam (flurazepam)
•Mogadon, Nitrazadon (nitrazepam)
•Restoril (temazepam)
•Apo-Triazo (triazolam)
•Imovane, Rhovane (zopiclone)
The updated Canadian product monographs for these drugs can be found by search of the Drug Product Database on the Health Canada website. The product monographs for the generic formulations (see the following list of Authorized sleep-aid medications in Canada for a list of generic sleep-aid drugs) will be updated in the future; patients taking generic sleep-aid drugs may at this time consult the Product Monographs of the brand-name products for the updated information.
Patients should typically not take sleep aid drugs for more than 7 to 10 days in a row. The drugs affected by this labelling change are all available by prescription only in Canada.
Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.
Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
•Report online at the MedEffect™ Canada section of the Health Canada website
•Call toll-free at 1-866-234-2345
•Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701C Ottawa, ON K1A 0K9
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Sunday, October 4, 2009
FDA Issues Strategic Plan for Risk Communication
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products
The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.
“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.
They include:
Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
Producing a research agenda for public dissemination
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.
Consumer Inquiries: 888-INFO-FDA
FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products
The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.
“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.
They include:
Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
Producing a research agenda for public dissemination
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect in some patients
New Heparin to Ship Starting October 8
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.
Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.
For more information
FDA Alert to Health Care Professionalshttp://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm
USP Heparin Informationhttp://www.usp.org/hottopics/heparin.html
Information for Consumers: What You Should Know about Changes to Heparinhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184504.htm
Consumer Inquiries: 888-INFO-FDA
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect in some patients
New Heparin to Ship Starting October 8
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.
Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.
For more information
FDA Alert to Health Care Professionalshttp://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm
USP Heparin Informationhttp://www.usp.org/hottopics/heparin.html
Information for Consumers: What You Should Know about Changes to Heparinhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184504.htm
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