Category Archives: Food and Drug Administration
The Food and Drug Administration (FDA) has released a new report that details steps the agency is taking to ensure that imported food, drugs, medical devices and other regulated products meet the same standards for safety and quality as those manufactured in the United States.
According to the agency, global production of FDA-regulated goods and materials has grown significantly in the last decade:
- FDA-regulated products originate from more than 150 countries; 130,000 importers and 300,000 foreign facilities.
- Each year from 2005 through 2011, food imports have grown by an average of 10 percent, pharmaceutical products by nearly 13 percent and device imports by more than 10 percent.
- About half of all fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of the seafood consumed in America, come from abroad.
- More than 80 percent of the active pharmaceutical ingredients used to make medicines are imported.
The agency says that through its international offices in Africa, Asia, Europe, Latin America and the Middle East, the FDA is increasing its knowledge base about local regulatory systems, and improving what foreign governments and industries know about FDA regulations and standards for products that will be sold in the United States. The agency says it is also collaborating to strengthen regulatory science and evidenced-based approaches to product safety and quality.
Read the Global Engagement Report.
Many low- and middle-income nations don’t have technologically advanced regulatory systems, which limits their oversight of food and drug safety, according to a new report from the Institute of Medicine. The report recommends 13 steps that the Food and Drug Administration (FDA) and other agencies can take over the next three to five years to bolster the safety systems in developing nations. They include:
- Developed nations should share technical expertise, training, and tools to strengthen the surveillance systems in developing countries.
- The United States should work with Mexico, the host of the next meeting of the G20 nations, to add food and medical product safety to the G20 agenda.
- FDA should evaluate its pilot Secure Supply Chain pilot program, which rewards firms that can track their products from manufacture to market with expedited entry into the U.S. market. If successful, FDA should expand the program to more drug firms and to food companies.
Read more food safety news.
The U.S. Departments of Health and Human Services (HHS) and Education have launched a new website to encourage children, parents, educators and communities to take action to stop and prevent bullying.
The website provides a map with detailed information on state laws and policies, interactive webisodes and videos for young people, practical strategies for schools and communities to ensure safe environments, and suggestions on how parents can talk about bullying with their children. Read more on a recent documentary that tells the stories of kids who were bullied.
A new study by scientists at Columbia University Mailman School of Public Health finds that neighborhood differences in rates of childhood asthma may be explained by varying levels of air pollution from trucks and residential heating oil. Read more on environmental health.
Facebook has announced a new service to help prevent suicides. The new service, a collaboration among Facebook, the Substance Abuse and Mental Health Services Administration, and the National Suicide Prevention Lifeline, lets Facebook users report a suicidal comment they see posted by a friend via either the Report Suicidal Content link or the report links found on the site. The person who posts the suicidal comment will immediately receive an e-mail from Facebook encouraging them to call the National Suicide Prevention Lifeline 1-800-273-TALK (8255) or to click on a link to start a confidential chat session with a crisis worker. See more mental health news.
According to the updated National Farmers Market Directory, since 2010, the number of winter markets has increased 38 percent, from 886 to 1,225. The top 10 states for these markets are New York, California, Pennsylvania, North Carolina, Ohio, Maryland, Florida, Massachusetts, Virginia and Michigan. According to the USDA, the expansion of hoop house technology, which lets growers extend their production cycles in colder climates, has enabled many smaller growers to extend their production seasons at low cost and has been a contributing factor in the rise of winter farmers markets, according to the US Department of Agriculture. See more farmers market news.
The risk of burns increases over the holiday season because people are cooking more, putting up potentially flammable decorations and using fireplaces and candles.
The Food and Drug Administration has released draft recommendations to increase the number of women enrolled in medical device clinical trials. Women are often underrepresented in these trials.
Judge Richard J. Leon of the U.S. District Court of the District of Columbia has granted a preliminary injunction against the Food and Drug Administration in a case filed in August by several cigarette manufacturers that challenged the constitutionality of nine new cigarette graphic warning labels.
The suit challenged the warning labels for cigarette packs, cartons and advertising on First Amendment grounds, and claims that the FDA regulation is an unconstitutional means of forcing tobacco manufacturers to disseminate the government's anti-smoking message.
>>Read a take on cigarette graphic warning labels from Surgeon General Regina Benjamin, MD, MBA, in an earlier NewPublicHealth Idea Gallery.
NewPublicHealth spoke with Maggie Mahoney, Deputy Director of the Tobacco Control Legal Consortium, about Judge Leon’s ruling.
NewPublicHealth: Were you surprised by the ruling?
Maggie Mahoney: We weren’t surprised that Judge Leon issued an unfavorable ruling. It most likely will be appealed to the U.S. Court of Appeals for the D.C. Circuit.
NPH: What does the injunction do to the implementation of the warning labels?
Q: How many "sharps," (needles, lancets, syringes and other sharp objects) are used and thrown away by Americans each year?
A: 7.8 billion.
The number—from the Coalition for Safe Community Needle Disposal, a non-profit group that includes government agencies, professional associations and businesses—is so large, and the danger from accidental infection so great, that the Food and Drug Administration (FDA) has launched a new website for patients and caregivers on safe disposal of sharps used at home, at work and while traveling.
According to the FDA, used sharps often end up in home and public trash bins or flushed down toilets, where they pose many risks including infecting others with viruses such as Hepatitis B and C and HIV.
The FDA offers this DO NOT list for sharps:
- Don’t throw loose sharps into the trash.
- Don’t flush sharps down the toilet.
- Don’t put sharps in a recycling bin; they are not recyclable.
- Don’t try to remove, bend, break or recap sharps used by another person.
- Don’t attempt to remove a needle without a needle clipper device.
“Safe disposal of used needles and other sharps is a public health priority,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “This website provides information about how to keep used sharps from ending up in places where they could harm people.”
The use of sharps has increased in recent years because of the increase in chronic diseases, such as diabetes, cancer, allergies, arthritis and HIV, that require self-management at home, according to the FDA.
A federal judge has issued a temporary injunction against the graphic warnings on cigarette packs announced by the Food and Drug Administration in June and expected to be fully implemented by September 2012. The judge says he expects a challenge by cigarette makers—that the rule violates the free speech rights of cigarette companies—to be upheld. Get more tobacco news.
A new study in the Archives of Pediatric and Adolescent Medicine finds that banning sodas in school did not decrease consumption among middle school students. Researchers say home consumption seems to be the most likely place kids drink sodas and that additional messages about the links between sugary beverages and obesity are needed. Read a related Q&A on the marketing of sugary drinks to children.
High blood pressure and other risk factors for stroke also increase the risk of developing cognitive problems, even among people who have never had a stroke, according to a new study funded by the National Institutes of Health. The study included over 30,000 people and was published in the journal Neurology.
First-time ever guidelines just released by the American Heart Association and the American College of Cardiology recommend that heart disease patients be screened for depression and that anyone who has a heart attack, stroke, bypass surgery, or a diagnosis of heart-related chest pain or blockages in leg arteries, be referred for cardiac rehabilitation.
Over the past 12 months, the Food and Drug Administration approved 35 new medicines, among the highest number of approvals in the past ten years. New drugs include two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
A new study has found that quitting smoking after a stroke is more likely if the portion of the brain responsible for processing emotions was affected by the stroke. The researchers, who published their findings in the journal Stroke, also found that smokers who planned to stop smoking before having a stroke were more than twice as likely to be non-smokers after a year compared to patients who hadn’t considered quitting
The White House issued an executive order yesterday to help remedy the current shortage of some prescription drugs, including some cancer medications. The order calls on the U.S. Food and Drug Administration to take a number of steps to intervene including adding staff, working with drug companies to alert the agency to impending drug shortages ahead of time and to investigate whether shortages are leading to price gouging. Prescription drug shortages tripled between 2005 and 2010.
The U.S. Department of Health and Human Services today released final standards to more consistently measure race, ethnicity, sex, primary language and disability status, thereby improving the ability to highlight health disparities and target interventions to reduce these disparities. Read up on health disparities here.
A new American Academy of Pediatrics policy statement recommends that pediatricians provide substance abuse education and screening to adolescents during routine clinical care, relying on protocols designed by the U.S. Substance Abuse and Mental Health Services Administration. Get more substance abuse news.
Children in rural areas are likely to face different challenges to their health and have less access to care compared with children in urban areas, according to a new report from the Health Resources and Services Administration (HRSA). The report, based on a survey of parents, finds greater prevalence of certain physical, emotional, behavioral and developmental conditions in rural areas.
- Children living in rural areas are more likely to have public insurance, such as Medicaid or the Children’s Health Insurance Program, while urban children are more likely to be privately insured.
- The percentage of children with chronic conditions such as obesity, asthma and diabetes is highest amongst teenagers living in small rural areas.
Read more on rural health.
The U.S. Food and Drug Administration and the National Institutes of Health have announced a joint, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations.
Investigators will follow more than 40,000 users of tobacco-products and those at risk for tobacco use, looking at what makes people susceptible to taking up smoking; use patterns; patterns of tobacco cessation and relapse in the era of tobacco regulation; the effects of regulatory changes on risk perceptions and other tobacco-related attitudes; and differences in attitudes, behaviors and key health outcomes across racial-ethnic, gender, and age subgroups. Read more tobacco news here.
The Food and Drug Administration has approved for marketing Juvisync, a fixed-dose combination prescription drug that contains two previously approved medicines in one tablet for use in adults whose doctors recommend both drugs for lowering cholesterol and treating diabetes. The goal of the combo drug is to improve adherence to both drugs by reducing the number of drugs needed for people prescribed both. Learn about a community-based diabetes prevention program at YMCA's across the country.
Septicemia, an illness caused by blood infections with bacteria such as E. coli and MRSA, was the single most expensive condition treated in U.S. hospitals — nearly $15.4 billion in 2009 — according to data from the Agency for Healthcare Research and Quality. Septicemia is the sixth most common reason for hospitalizations.