Category Archives: Food and Drug Administration
The U.S. Food and Drug Administration (FDA) was a partner agency for last week’s Preparedness Summit in Atlanta. NewPublicHealth spoke with Brooke Courtney, Senior Regulatory Counsel in the FDA Office of Counterterrorism and Emerging Threats, about how the agency plans for disasters it hopes never occur. Previously, Courtney was the Preparedness Director at the Baltimore City Health Department and in that role oversaw all of the public health preparedness and response activities for Baltimore City.
NewPublicHealth: What did you speak about at the Summit last week?
Brooke Courtney: FDA views the summit as an unparalleled opportunity each year to engage with stakeholders at the state, local and federal levels—to share with them updates from the federal side and also for us to get feedback from them about challenges and successes. We engage with stakeholders on a regular basis, but this is really the meeting where the largest number of people involved in preparedness come together, and it’s a great opportunity to see people face-to-face.
We feel really fortunate to have been able to take part in the summit for the past few years. For this year’s summit FDA served on the Planning Committee and also participated in the medical countermeasure policy town hall with federal colleagues from the Office of the Assistant Secretary for Preparedness and Response, the U.S. Department of Homeland Security and the national security staff, all of whom we work with closely.
Another thing that we like to do at the summit each year is to give a more in-depth update through a session with the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Department for Health and Human Services (HHS) legal counsel on the authorities that we have that we use related to the emergency use of medical countermeasures during emergencies. This year’s session was especially exciting for us because it was an opportunity for us to discuss with stakeholders some new authorities that were established in 2013 to enhance preparedness and response flexibility.
For example, we can now clearly issue emergency use authorizations in advance of emergencies, which is really a critical medical countermeasure tool for preparedness purposes. Through these flexibilities, for example, we’ve issued three emergency use authorizations in the past year for three different in-vitro diagnostic tests to address the emerging threats of H7 and 9 influenza and MERS-CoV.
NPH: What are the key responsibilities the FDA has in helping to prepare the United States for possible disasters?
Courtney: As an agency of the U.S. Department of Health and Human Services, the FDA, at its core, is a public health agency. FDA’s mission is to protect and promote public health in a number of critical ways. We’re responsible for regulating more than $1 trillion in consumer goods annually, ranging from medical products such as drugs and vaccines to tobacco and food products.
In an effort to combat the growing epidemic of prescription drug abuse and overdose, the U.S. Food and Drug Administration (FDA) has approved a small, easy-to-use injector—similar to an EpiPen—that can be used to revive people who have stopped breathing or lost consciousness from an opioid drug overdose. The device, called Evzio, provides a single dose of naloxone, which is the standard treatment for opioid overdoses but up until now was mostly only available in hospitals and other medical settings.
The device, expected to be available starting this summer, will enable early intervention that increases the chances of survival. According to the National Center for Injury Prevention and Control , nationally, sales of prescription painkillers per capita have quadrupled since 1999—and the number of fatal poisonings due to prescription painkillers has also quadrupled.
The FDA’s approval comes at a critical time. In October of last year, Trust for America’s Health released a report that found that a very small number of states are implementing more than just a few promising strategies that have been identified to help combat the widespread drug abuse that continues to increase across the United States. The report, Prescription Drug Abuse: Strategies to Stop the Epidemic, which was funded by a grant from the Robert Wood Johnson Foundation, showed that only two states—New Mexico and Vermont—have implemented all ten strategies. TFAH also released an interactive tool with state-by-state prescription drug overdose death rates and state scores on the 10 key steps to curb abuse.
Carl R. Sullivan III, MD, director of the addictions program at West Virginia University, said the FDA’s approval of Evzio “is a big deal, and I hope [it] gets wide attention,” according to The New York Times. “It’s pretty simple: Having these things in the hands of people around drug addicts just makes sense because you’re going to prevent unnecessary mortality.”
Read the full story from The New York Times.
CDC: Calls to Poison Centers for E-Cigarettes Has Jumped Dramatically Since 2010
Calls to poison centers involving e-cigarette liquids containing nicotine jumped from just one per month in September 2010 to 215 per month in February 2014, according to a new U.S. Centers for Disease Control and Prevention (CDC) study in the Morbidity and Mortality Weekly Report. There was no similar increase for conventional cigarettes. The study found that 51.1 percent of the e-cigarette calls involved children under age 5 and about 42 percent involved people ages 20 and older. “This report raises another red flag about e-cigarettes—the liquid nicotine used in e-cigarettes can be hazardous,” said CDC Director Tom Frieden, MD, MPH, in a release. “Use of these products is skyrocketing and these poisonings will continue. E-cigarette liquids as currently sold are a threat to small children because they are not required to be childproof, and they come in candy and fruit flavors that are appealing to children.” Read more on the FDA.
HHS Draft Report Would Strengthen Innovative Health IT, Help Patients
The U.S. Department of Health and Human Services (HHS) has released a draft report that includes a proposed strategy for a health information technology (health IT) framework to help promote product innovation while also ensuring patent protections and avoiding regulatory duplication. The congressionally mandated report was developed by the U.S. Food and Drug Administration in consultation with HHS’ Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC). “The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.” Improved health IT could help lead to greater prevention of medical errors; reductions in unnecessary tests; increased patient engagement; and faster identifications of and response to public health threats and emergencies. Read more on technology.
Study: Fewer Cases of Smoking on TV Screens May Be Tied to Overall Drop in U.S. Smoking Rates
Fewer scenes of cigarette use in prime-time television shows may be linked to an overall reduction in the U.S. smoking rate, according to a new study in the journal Tobacco Control. Analyzing 1,800 hours of popular U.S. prime-time dramas broadcast between 1955 and 2010, researchers from the Annenberg Public Policy Center at the University of Pennsylvania in Philadelphia determined that scenes involving cigarette use on such shows fell from nearly five scenes per hour of programming (excluding commercials) in 1961 to about 0.3 scenes per hour in 2010. Based on this data they concluded that one less depiction of smoking per hour over two years of prime-time programming was associated with an overall drop of almost two packs of cigarettes, or 38.5 cigarettes, a year for every adult. The new findings support previous research showing that seeing other people smoke prompts cigarette cravings in adult smokers. Read more on tobacco.
Mistrust, Perceived Discrimination Affect Young Adult Latinos’ Satisfaction with Health Care
Mistrust of the medical community and perceived discrimination can affect how satisfied young adult Latinos are with their health care, which in turn can influence health outcomes, affect participation in health care programs under the Affordable Care Act and contribute to disparities in health care access, according to a new study in The Journal of Rural Health. Researchers surveyed 387 young adult Latinos, ages 18-25, finding that approximately 73 percent were moderately or very satisfied with their health care, but among those who were not, medical mistrust and perceived discrimination were found to be factors. The researchers recommend improving “cultural competency” among health care providers—from the doctors to the receptionists to the lab technicians—to help ensure Latinos are treated with respect and dignity, and also that a bilingual/bicultural workforce may be more effective at building trust. “Trust is huge; it allows patients to disclose concerns and be honest,” said study co-author S. Marie Harvey, associate dean and professor of public health at Oregon State University in a release. Read more on health disparities.
FDA Approves First Sublingual Home Treatment for Hay Fever
The U.S. Food and Drug Administration (FDA) has approved the first sublingual—or under the tongue—allergen extract for use in the United States. Designed to treat hay fever with or without conjunctivitis that results from exposure to certain grass pollens in people ages 10-65, the first dose is administered in a health care providers office so that the patient can be observed for any adverse reactions, but can then be taken at home. Approximately 30 million Americans and 500 million people worldwide are affected by hay fever, also known as allergic rhinitis, which can cause repetitive sneezing; nasal itching; runny nose; nasal congestion; and itchy and watery eyes. “While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a release. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office.” Read more on the FDA.
New Report Analyzes Link Between Metro Areas and Overall Health
People who live in compact, connected metropolitan regions are more likely to see their incomes rise, have lower household costs, have more transportation options and live longer, safer and healthier lives, according to Measuring Sprawl 2014, a new report from Smart Growth America and the University of Utah’s Metropolitan Research Center. The report looks at 221 major U.S. metropolitan areas, ranking them based on how sprawling or compact they are as well as examining how sprawl relates to factors such as economic mobility; the cost of housing and transportation; life expectancy; obesity; chronic disease and safety. “Smart growth strategies are about making life better for everyone in a community,” said Geoff Anderson, President and CEO of Smart Growth America. “If policymakers are looking for ways to lower costs for their constituents, improve public health and support their broader economy, they need to be thinking about how to improve their development.” Read more on community health.
Recently, we’ve been pleased to see increased engagement across a number of posts on NewPublicHealth, particularly from public health students. Reader comments have pointed a justly critical eye toward the way studies are often interpreted and presented. This level of conversation is critical to informing and bolstering NewPublicHealth’s coverage of public health news and issues.
We have compiled a handful of reader comments below, in an effort to continue the discussion.
- Readers shared their opinions on a survey showing that Hispanic adults are not confident in their understanding of insurance terms:
- “Although the concern of this study was the disparity between white literacy and non-white literacy, general focus should be placed on understanding for people in all racial categories. A lack of health literacy leads to many issues in health care, often resulting in ineffectiveness of care.” — Jessica H.
- “The study regarding the lack of understanding of key insurance terms is interesting because while it specifically shows low-literacy levels in Hispanics, it points to a larger problem in America. Relative to this study, literacy levels were highest in Whites and lowest in Hispanics. Overall, the literacy levels were universally low. This is a problem because being unable to understand insurance terms would lead to less effective use of the insurance, or no insurance at all.” — Michael
- Readers also questioned the validity of a study that found many parents support flu shots at school, based on concerns regarding data collection methods and information presentation biases:
- “Regarding the study that found that many parents support flu shots at school: The survey used in this study was given in English, but it was found that people most likely to agree to have their children vaccinated in a school setting included parents of uninsured children...If children are not insured, it usually means the parents are not insured and have jobs that do not provide health benefits. Immigrants usually work these kinds of jobs, and probably do not speak English well. So, if the survey was only given in English, this could influence the results of the study...” — Brittany
- “Surveys aren’t the best method of collecting data. Secondly, the convenience portion, which includes vaccine beliefs and or skipping past vaccines greatly contributed to the unwillingness to consent...And this would create a high stated consent rate, due to parental preferences based on location...Lastly, although the author wrote this study with intentions of public health official’s consideration to this topic I would be concerned since this study is the first to provide this information and does however contain many biases.” — Cora Neville
- “The article mentions that only parents who answered with a yes or not sure were asked follow up questions. If a parent answered no, was there a question that asked why they would not consent?...I think collecting data on those who declined the school-located vaccination would help future researchers find a way to get those parents who originally declined to consent.” — Shannen Mincey
- Many people in the public health field have publicly weighed in on the U.S. Food and Drug Administration’s proposed changes to food labels, including NewPublicHealth readers:
- I think some parts of this new regulation will be good for consumers while others will simply be a futile effort to help consumers eat better. For example, I believe adding “added sugars” to the label will be effective in identifying the bad sugar...One change that could be helpful for consumers would be to identify the types of fiber. Although the label includes total dietary fiber, this can be misleading to consumers who may not realize they are not getting nutritional value out of all of it.” — Jessica H.
- “Food labels need to be more understandable and consumer friendly. The Healthy People Campaign and health advocates, such as Michelle Obama want America to take responsibility for their health, yet the consumers have to dissect every food label to get a proper gauge of the nature of the food they’re consuming... On the same token, I think it is going to take a great deal of further research to determine what would be considered “better align[ed] with how much people really eat.’” — Vanessa Moses
Thank you to all our readers who have made their opinions known. Let’s keep these conversations going!
2013 America’s Health Rankings Finds Significant Progress in National Health
The new 2013 America’s Health Rankings from the United Health Foundation finds that while there is still much progress to be made, over the past year Americans improved in the majority of the measures that the Rankings use to rate public health. The improved areas include smoking rates, which fell to 19.6 percent of the adult population, from 21.2 percent the previous year, as well as physical inactivity, which fell to 22.9 percent from 26.2 percent. Also, for the first time since 1998 the obesity rate did not rise. With low rates of uninsured people, high rates of childhood immunization and low rates of health issues such as obesity and smoking, Hawaii ranked as the healthiest state in the country. Read more on community health.
FDA to Phase Out Use of Certain Antimicrobials in Food Animals
The U.S. Food and Drug Administration (FDA) is moving forward with a plan to combat the spread of antibacterial resistance by prohibiting the use of medically important antimicrobials in food animals for food production purposes, while also adding veterinary oversight to therapeutic use of the drugs in animals. Antimicrobials can be used in the food and drinking water of cattle, poultry and other food animals to encourage weight gain. However, these same antimicrobials are used to treat infections in humans, and their availability in the food supply increases the possibility of the development of antimicrobial resistance. The FDA is giving companies three months to sign on to the strategy, then three years to transition. “This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” said Bernadette Dunham, DVM, PhD, director of the FDA’s Center for Veterinary Medicine. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working—and will continue to work—to make this transition as seamless as possible.” Read more on food safety.
HHS: 365,000 Enrolled Under Affordable Care Act in October, November
The official numbers are in, with almost 365,000 people selecting plans in the Health Insurance Marketplace in October and November, according to the U.S. Department of Health and Human Services. About 1.9 million people have gone through the online process, but have just not yet selected a plan, while more than 800,000 were determined eligible for Medicaid or the Children’s Health Insurance Program (CHIP). The site went live at the beginning of October, but extensive bugs and glitches meant only about 27,000 people were able to sign up in that first month. Last week a reconfigured HealthCare.gov was launched after about five weeks of work spent addressing the problems, and 29,000 people were able to sign up during the first two days alone. Thirty-six states use HealthCare.gov, with fourteen states and Washington, D.C. maintaining their own sites. Read more on the Affordable Care Act.
Chicago Announces Trio of Anti-tobacco Initiatives to Curb Youth Smoking
The city of Chicago and Mayor Rahm Emanuel this morning announced a trio of anti-tobacco initiatives designed to reduce youth access to tobacco. The first would regulate e-cigarettes as tobacco products, while the second would restrict the sale of flavored tobacco products near schools and the third would work to educate the public on the dangers of menthol-flavored cigarettes. Further details:
- By defining “tobacco products” as products that are made of tobacco or include tobacco-derived nicotine, the city would be able to regulate e-cigarettes as they do any other tobacco product. This would mean that under the Chicago Clean Indoor Air Act, e-cigarette use would be restricted everywhere where smoking is restricted, including almost all public places and places of employment.
- Flavored tobacco products, including menthol products, could not be sold within 500 feet of schools, and existing stores would not be grandfathered in. This would be the first regulation of menthol-flavored cigarettes anywhere at the federal, state or local levels.
- Understanding that menthol-cigarettes are often—and wrongly—viewed as less unhealthy than other tobacco products, as well as that fact that the flavoring makes them more appealing to kids, the city is launching a public service advertising campaign on the realities of the products.
“E-cigarettes, as well as flavored products, are gateway tobacco products targeted at our kids,” said Emanuel. “The tobacco industry has spent years developing products that are aimed at hooking our youth on nicotine and getting them smoking for their entire life.” Read more on tobacco.
FDA to Investigate Reports on Weight-related Problems with the Morning-After-Pill
Following yesterday’s report that the European equivalent of the Plan B One-Step “morning after pill,” Norlevo, is less effective for women who weigh 165 pounds or more and ineffective for women who weigh 176 pounds or more, the U.S. Food and Drug Administration (FDA) has announced it will perform its own investigation into the product. The agency is "currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based," said FDA spokeswoman Erica Jefferson said in a Monday statement. "The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted." By law, the morning-after pill is available to all U.S. women of child-bearing age, over the county and with no point-of-sale restrictions. Read more on sexual health.
Concerns Over Cost, Sexual Activity Keep Many Parents From Having Kids Vaccinated Against HPV
Costs and parental concern over their kids’ sexual activity may be the reason that so view children—both girls and boys—are not being vaccinated against the human papillomavirus (HPV), according to a new review of 55 studies appearing in JAMA Pediatrics. HPV vaccines protect against the strains of genital warts that cause approximately 70 percent of cervical cancers, and they are recommended for girls aged 11 to 12. Boys are recommended to receive the vaccine as young as age 11, as it protects not just against genital warts, but also oral, penis and rectal cancers. However, the review found that many parents put off the vaccination either because they believe their child is not sexually active—so doesn’t “need” the vaccine—or because they fear it will encourage them to become sexually active. Researchers determined that a physician’s recommendation was one of the strongest motivators toward deciding to accept the vaccination, although this did not happen nearly enough. The researchers recommended improving these statistics by educating doctors and parents on the importance of the vaccine. Read more on cancer.
Tobacco featured prominently as a public health issue at the American Public Health Association (APHA) meeting this week, including a regulatory update from Mitch Zeller, JD, who became director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products earlier this year. Zeller previously worked on tobacco issues in government as associate commissioner and director of FDA’s first Office of Tobacco Programs, and also as a U.S. delegate to the World Health Organization (WHO) Working Group for the Framework Convention on Tobacco Control.
NewPublicHealth spoke with Zeller ahead of the APHA meeting.
Mitch Zeller: I think most broadly my goals are to help give the center and the agency the greatest chance of fulfilling the public health mission behind the law passed in 2009 giving the Food and Drug Administration authority over tobacco. This really is an important piece of legislation. It’s really stunning that in 2013—with everything that we know about the harms associated with tobacco use—that it remains the leading cause of preventable death and disease both in this country and globally.
There are some very powerful tools that Congress has given FDA to use wisely and supported by evidence. That’s where I think, the greatest opportunity lies: to use the tools relying on regulatory science to try to protect consumers and reduce the death and disease toll from tobacco.
There are two areas where I think these tools can make a profound positive impact on public health. The first is something called product standards, which is basically the power to ban, restrict or limit the allowable levels of ingredients in tobacco or tobacco smoke. We are exploring potential product standards in three areas: toxicity, addiction and appeal. And we are funding research in all three areas and working very hard behind the scenes to find out what our options are for potential product standards in those three areas.
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.