Category Archives: Food and Drug Administration
After years of deliberation, the U.S. Food and Drug Administration (FDA) has issued final guidance on the regulation of smartphone medical devices. In a nutshell, generally speaking any device used in diagnosis or treatment can’t be marketed until it’s approved by the FDA; other apps—such as calorie counters, or pedometers built into a phone—don’t need the FDA’s nod. The FDA’s criteria is how much risk an app poses for a consumer. The agency says it “intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.”
Specifically, the FDA will focus its oversight on mobile medical apps that:
- Are intended to be used as an accessory to a regulated medical device—for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.
- Transform a mobile platform into a regulated medical device—for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine whether a patient is experiencing a heart attack.
“We have worked hard to strike the right balance, reviewing only the mobile apps that has the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
While the final guidelines were only just released, FDA has cleared 100 mobile medical apps for marketing in the last few years, and 40 of those were just in the last two years.
Synim Rivers, an FDA spokesman, answered questions for NewPublicHealth about the final guidance on mobile medical apps.
Ahead of the annual pilgrimage of Muslims to Mecca and Medina in Saudi Arabia this October, the Saudi health ministry is limiting the number of foreign and local pilgrims in order to lower the risk of the spread of H7N9, a new form of avian flu identified several months ago in China, and MERS, or Middle East respiratory syndrome corona virus (MERS/MERS-CoV), a potentially fatal virus that emerged last year. The largest numbers of cases of the virus—and deaths—have been in Saudi Arabia. According to a recent post on the Network for Public Health Law’s (NPHL) blog by Daniel G. Orenstein, JD, deputy director of NPHL’s Western Region, so far neither the U.S. Centers for Disease Control and Prevention nor the World Health Organization have issued travel restrictions about the Hajj.
However, the post does note that the emergence of the two viruses has prompted the U.S. Food and Drug Administration (FDA) to take action under its legal authority to increase U.S. readiness to treat potential outbreaks of H7N9 and MERS. Under the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the FDA recently issued Emergency Use Authorizations (EUAs) for diagnostic tests for both viruses. EUAs enable the FDA to temporarily allow use of unapproved medical products such as antibiotics, vaccines and diagnostic tests needed during emergencies.
Orenstein says that “issuing the EUAs illustrates the flexibility and adaptability of FDA authority as clarified under PAHPRA. As epidemiologic research develops further on these viruses, FDA will be able to respond quickly, hopefully mitigating the impact on population health.”
>>Read more: Read the full post on the Network for Public Health Law’s blog.
“Are they harm reduction or are they smoking cessation? It’s a tough situation because, on the one hand, you have what it does and on the other you have the claims are that are allowable under the law. It’s a strange situation where they are being regulated as tobacco products. But they are not tobacco products. There’s no tobacco in them.”
Many hard facts about e-cigarettes are still unclear. What is clear is that marketers are pushing hard to make the switch from smoking to “vaping” an ongoing trend. In the above quote from a TechCrunch article, Michael Siegel, MD, Professor at Boston University’s Public School of Health, mulled over some very real concerns about where we’re heading in terms of e-cigarette regulation.
The current debate between the manufactures and public health experts surrounds the health impacts of the nicotine product. The e-cigarette “boom” began around 2007, starting first with smaller companies. After making a dent in cigarette sales—unlike cessation therapies such as the patch and gums—tobacco companies took notice and are starting to jump onboard.
Today e-cigarettes are especially rising in popularity among what some may consider the “hip” crowd. From a recent article in The New York Times:
Conflicts of Interest in Determination of Food Additive Safety
Who determines whether a food additive is safe? Often it’s people with ties to the food additive industry, according to a new conflict-of-interest study from The Pew Charitable Trusts in the journal JAMA Internal Medicine. From 1997 to 2012, about 20 percent of safety determinations submitted to the U.S. Food and Drug Administration were authored by employees of food additive manufacturers, and 13 percent were authored by someone working a consultant selected by the manufacturer. Researchers also found that the expert panels tasked with conducting most of the safety assessments rely on many of the same experts over and over again. "There's a cadre of 10 people that serve on almost all of these expert panels," said study author Thomas Neltner, director of Pew's food additives project. "Three-quarters of the panels contained at least one of these people. One person served on 44 percent of the panels, which tells us there's not only conflicts of interest, but there's a very small group of people making these decisions." Michael Jacobson, executive director of the Center for Science in the Public Interest, sees these results as a clear problem that needs to be addressed. "These committees give a very superficial, one-sided review," he said. "They want to please the sponsor, and then maybe they will get more business because they've proven themselves trustworthy, but it's no way to run a food safety review process." Read more on food safety.
CDC: 1 in 8 Preschoolers Obese, Raising their Risk for Adult Obesity
About one in eight—or 12 percent—of preschoolers are obese. However, after decades spent watching that number climb, nineteen states and territories are seeing drops in obesity among low-income preschoolers, according to the latest Vital Signs report from the U.S. Centers for Disease Control and Prevention (CDC). Overweight and obese children are five times more likely to grow up to be obese adults, so early intervention by state and local health officials is critical. The report provides a number of ways they can help, including the creation of partnerships with community members to make community changes that promote healthy eating and active living, as well as making it easier for families with children to buy healthy, affordable foods and beverages in their neighborhoods. Read more on obesity.
Hospitals’ Exchange of Electronic Health Records Climbed 41 Percent from 2008 to 2012
Health information exchange (HIE) between hospitals and providers outside their organizations climbed 41 percent from 2008 to 2012, with six in 10 hospitals exchanging electronic health records (EHR) in 2012, according to a new study in the journal Health Affairs. The researchers say this illustrates how EHRs have become complementary tools that improve health care quality and safety. “We know that the exchange of health information is integral to the ongoing efforts to transform the nation’s health care system and we will continue to see that grow as more hospitals and other providers adopt and use health IT to improve patient health and care,” said Farzad Mostashari, MD, the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services. “Our new research is crystal clear: health information exchange is happening and it is growing. But we still have a long road ahead toward universal interoperability.” Read more on technology.
Self-monitoring Tied to Improved Blood Pressure
Self-monitoring of blood pressure is tied to lower blood pressure in people with hypertension, according to a new study in the Annals of Internal Medicine. The study found the strategy was most successful when combined with providing extra resources to patients, such as online materials. Hayden Bosworth, of the Duke University Medical Center and the Durham Veterans Affairs Medical Center in North Carolina, said self-monitoring can provide more accurate results because the patients are not feeling the stress that they would in the doctor’s office. It also provides more in terms of actual data, which helps physicians to better determine treatments, and helps patients take a constant ownership of their health. "If you eat five ham biscuits for breakfast … you can see the implications of that through your blood pressure in monitoring that relatively quickly, as well as if you exercise," said Bosworth to Reuters. "It's no different than tracking your own weight. You need to know, on a daily basis, how you're doing, what sets it off and are you going too high or too low." Read more on heart health.
New Association Represents Accredited Public Health Schools and Programs
The new Association of Schools and Programs of Public Health (ASPPH), which represents schools and programs of public health accredited by the Council on Education for Public Health (CEPH), officially launched on August 1. “This is a seminal moment in CEPH-accredited public health education,” says Dr. Harrison Spencer, president and CEO of ASPPH. “Representing both accredited schools and programs of public health gives the association and our members an opportunity to strengthen public health education, research, teaching, and practice.” The U.S. Department of Education has recognized CEPH as the accrediting body for public health schools and programs, which helps ensure the quality education and training necessary to prepare graduates for the future of public health work. Read more on accreditation.
Flu Vaccine for All Four Seasonal Strains Approved for Shipment
The first vaccine to protect against all four strains of seasonal influenza has been approved for shipment for the U.S. Food and Drug Administration. GlaxoSmithKline’s Fluarix Quadrivalent vaccine was approved late last year for use in adults and children aged 3 and older, but regulations require flu vaccines to be approved before they are shipped to health care providers each season. The company estimates it will ship approximately 22 to 24 million doses globally, with 10 million doses in the United States. The U.S. Centers for Disease Control and Prevention has ordered more than 4 million doses. Read more on influenza.
Nine-state Study Shows Statewide Smoking Bans Would Not Hurt Restaurant, Bar Business
Despite the concerns of many proprietors, statewide smoke-free laws would not hurt business at restaurants and bars, according to a new study in the journal Preventing Chronic Disease. Bans on workplace and public area smoking reduce exposure to secondhand smoke, encourage smokers to quit, improve the health employees and reduce the risk for heart attack hospitalizations. The findings of the CDC Foundation study—the largest such analysis, with nine states—line up with previous research. The participating states were chosen because they do not have statewide smoking bans, but do have a good deal of local laws. “Smoke-free laws make good business sense—they improve health, save lives, increase productivity, and reduce health care costs,” said U.S. Centers for Disease and Control Prevention Director Tom Frieden, MD, MPH. Communities throughout the United States have made great strides in protecting workers and the public from secondhand smoke in the past decade, but too many Americans continue to be exposed to secondhand smoke on the job and in public places.”
Below is a related smoke-free video for the state of Texas. Watch all the videos here.
Read more on tobacco.
FDA Sets New Standards for ‘Gluten-free’ Food Labeling
The U.S. Food and Drug Administration (FDA) has set a new standard to define “gluten-free” for voluntary food labeling. People with the autoimmune digestive condition of celiac disease—about 3 million Americans—can manage the condition by eating a diet free of gluten, which is found in naturally in wheat, rye, barley and cross-bred hybrids of these grains. Under the new rules, “gluten-free” labeling is restricted to products that meet all of the FDA requirements, including that the food contains less than 20 parts per million of gluten. The standards also apply to products that claim “no gluten,” “free of gluten” and “without gluten.” FDA is giving food manufacturers one year to come in line with the new standard. “Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, MD. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.” Read more on food safety.
CDC: Murders from Guns Down, But Suicide Rate is Up
The latest Morbidity and Mortality Weekly Report from the U.S. Centers for Disease Control and Prevention (CDC) has both good and bad news on gun violence—and both stress the need for further measures to reduce gun violence, especially early prevention. According to the CDC, gun-murder rate is down, but the suicide rate is up. The murder rate dropped around 15 percent from 2006-07 to 2009-10 in the majority of the fifty largest U.S. cities, but the suicide rate climbed as much as 15 percent in about 75 percent of the cities. In 2009-10 there were approximately 22,500 murders and 38,000 suicides involving a gun. "If there is any question that gun control is a big problem, here's a good example of why," said Victor Fornari, MD, chief of child and adolescent psychiatry at Zucker Hillside Hospital in Glen Oaks, N.Y. "Access to firearms is a serious public health problem. Limiting access to firearms would reduce homicide as well as suicide. As long as guns are available there are going to be these violent outcomes." Read more on violence.
CDC Issues First Comprehensive Report on Children’s Mental Health in the United States
As many as one in five American children under the age of 17 has a diagnosable mental disorder according to a new report from the Centers for Disease Control and Prevention. The report is the first expansive report on children's mental health ever done by the U.S. government and looked at six conditions:
- attention-deficit/hyperactivity disorder (ADHD)
- behavioral or conduct disorders
- mood and anxiety disorders
- autism spectrum disorders
- substance abuse
- Tourette syndrome
The most common disorder for children age 3 through 17 is ADHD (7 percent) followed by behavioral or conduct problems (3.5 percent), anxiety (3 percent), depression (2 percent), and autism spectrum disorders (1 percent).
Five percent of teens reported abusing or being dependent on illegal drugs, 4 percent abused alcohol and 3 percent reported smoking cigarettes regularly. Boys were more likely than girls to have the disorders. Read more on mental health.
New PSAs Help Parents Talk to Younger Kids about the Dangers of Underage Drinking
“Talk. They Hear You,” is a new national public service announcement (PSA) campaign from the Substance Abuse and Mental Health Services Administration (SAMHSA) to empower parents to talk to children as young as nine about the dangers of underage drinking. SAMHSA research shows that more than a quarter of American youth engage in underage drinking, and though there has been progress in reducing the extent of underage drinking in recent years, particularly among those aged 17 and younger, the rates of underage drinking are still unacceptably high, according to SAMHSA. A report from late last year shows that 26.6 percent of 12-20 year-olds report drinking in the month before they were surveyed and 8.7 percent of them purchased their own alcohol the last time they drank, despite the fact that all fifty states and the District of Columbia currently have laws prohibiting the purchase and use of alcoholic beverages by anyone under age 21.
“Even though drinking is often glamorized, the truth is that underage drinking can lead to poor academic performance, sexual assault, injury, and even death,” said said SAMHSA Administrator Pamela S. Hyde.
The goal of the new PSA is to help parents start a conversation about alcohol before their children become teenagers. Read more on addiction.
Advocacy Groups Petition FDA to Ban Menthol Flavored Cigarettes
In response to a Citizen Petition by close to twenty health and tobacco control advocacy groups, the Food and Drug Administration has opened a docket for public comment on banning menthol in cigarettes. In 2009, according to the Tobacco Control Legal Consortium, the lead group on the petition, Congress banned all flavors in cigarettes except menthol, and directed the FDA to decide whether continued sale of menthol cigarettes is “appropriate for public health." According to the petition, menthol cigarettes are the source of addiction for nearly half of all teen smokers. Read more on tobacco.
The U.S. Food and Drug Administration (FDA) has announced that it will investigate the safety of caffeine in food products, especially the effects of caffeine on children and teens. The FDA’s announcement comes as an increasing number of food companies have introduced food products that contain caffeine—including gum, jelly beans, hot sauce, marshmallows and Cracker Jacks.
Caffeine can be addictive, and can lead to high blood pressure and insomnia, according to the American Academy of Pediatrics (AAP). AAP discourages the use of caffeine by kids and teens. Caffeine levels vary in the new foods on the market. According to the FDA, a caffeinated version of Wrigley’s gum contains as much caffeine as four ounces of coffee, per piece. The new caffeinated gum packs each contain eight pieces of gum.
New Report Widens Information on Veteran Suicide
The Department of Veterans Affairs (VA) has released a comprehensive report on Veterans who die by suicide—include veterans who had not sought VA health care services. Previous reports included information only on those who had sought those services. The VA has recently implemented broader suicide prevention initiatives, including a toll-free Veterans Crisis Line; placement of suicide prevention coordinators at all VA medical centers and large outpatient facilities; and improvements in case management and reporting. Immediate help for veterans is available at www.VeteransCrisisLine.net or by calling the Crisis Line at 1-800-273-8255 (push 1) or texting 838255. Read more on military.
FDA Approves Generic Version for Cancer Drug Doxil in Short Supply
The U.S. Food and Drug Administration (FDA) has approved the first generic version of widely used cancer drug Doxil (doxorubicin hydrochloride liposome injection). This approval is critical because the drug is currently on the FDA’s drug shortage list. The agency is using a priority review system to expedite the review of generic applications to help stem shortages. Doxil is used for several cancers, including ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Read more on prescription drugs.
Stroke Victims Need Therapy Within 60 Minutes of Hospital Arrival
People having an ischemic stroke should receive clot-dissolving therapy within 60 minutes of arriving at the hospital, according to new American Stroke Association guidelines published in the journal Stroke. Ischemic stroke, which accounts for nine in 10 strokes, is caused by a blood clot in the arteries leading to the brain. According to the American Heart Association, calling 9-1-1 immediately after recognizing any of the warning signs of stroke—and getting to a stroke center as fast as possible—are critical steps for optimal stroke care. That’s because during an acute stroke, physicians must quickly evaluate and diagnose patients to determine whether they are eligible to receive the clot-dissolving drug recombinant tissue plasminogen activator which has to be given within hours of symptom starting.
Other new changes to stroke guidelines include:
- If feasible, transfer patients to the closest available certified primary care stroke center or comprehensive stroke center, which might involve air medical transport, though telemedicine with a stroke center may also be appropriate.
- Create multidisciplinary quality improvement committees within hospitals to review and monitor stroke care.
Read more on heart health.
The U.S. Food and Drug Administration (FDA) yesterday announced it is requiring the manufacturers of widely used sleeping pills that contain the active ingredient zolpidem, to lower current recommended doses. Recommended doses will be required to be lowered on drug labels that doctors use to prescribe medicines and on medication guides given to patients, for the following drugs: Ambien, Ambien CR, Edluar and Zolpimist. FDA is also urging physicians to prescribe the drugs at the lowest dose capable of treating the patient’s insomnia.
The FDA announcement is based on driving simulation and laboratory studies showing that, in some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident. Reducing deaths from motor vehicle accidents is a priority for the Centers for Disease Control and Prevention. While these deaths declined between 2000 and 2009, car crashes are still among the top ten causes of death for all Americans.
New data is driving the announcement, according to the FDA. “Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said Dr. Unger. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”