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Remarks by Chief of Staff Lauren Silvis at the Rural Health Symposium

Remarks by Lauren Silvis
Chief of Staff, FDA
Rural Health Symposium
Thursday, October 26, 2017
White Oak, MD


I’m delighted to join you today on behalf of FDA’s Commissioner, Dr. Scott Gottlieb, for this very important first-ever FDA symposium on rural health.  I want to thank both your office and the Office of External Affairs for putting on this great program.

I can’t think of a more opportune time to hold this meeting and I’m especially pleased that a broad cross section of officials, experts, and key stakeholders were able to participate today from FDA, other federal agencies, state offices, members of Tribal communities, and healthcare professional organizations, who are deeply engaged in these issues.

This enthusiasm and engagement affirms the importance of coordinating and collaborating to take on these difficult public health challenges affecting our nation, particularly for those in our rural and Tribal communities. 

Health care is not one sizes fits all. This is particularly true in our nation’s rural health care communities, which face unique challenges.  I often hear that the distance patients have to travel, and finding reliable transportation, can be significant hurdles to accessing care, whether for routine care for individuals living with HIV/AIDS to expectant mothers wanting to given their children the very best start in life by making sure they received prenatal care during their pregnancies, and how traveling long distances could be barriers to accessing this important care.  I also  hear of how communities have come together through innovative partnerships on behalf of patients to help address the health care challenges they tackled in their communities, such as through community health centers. 

The challenges rural communities face in both attracting and retaining health care professionals can compound the difficulties in ensuring patients in these areas receive high-quality care.  The rural population is, on average, older and sicker, requiring more frequent or more specialized care.  Statistics underscore the gap these communities face. According to the CDC, Americans living in rural areas are more likely than the rest of the population to die from the five leading causes of death – heart disease, cancer, unintentional injuries, chronic lower respiratory disease and stroke. 

And there are other differential health conditions.  People in rural areas have higher rates of cigarette smoking, high blood pressure, and obesity.  They have a higher rate of death from motor vehicle accidents than residents of urban America, a higher rate of suicide, and a higher rate of death by drug overdose. 

And tribal communities are particularly at risk.  Across the lifespan, American Indians and Alaska Natives have higher rates of disease, injury, and premature death than other racial and ethnic groups in the United States, including a higher prevalence of obesity, double the rate of diabetes, higher rates of death due to stroke and heart disease, and a higher likelihood of being a current smoker.

I know that most of you are all too familiar with these statistics, and many of you have been working, for years in many cases, on responding to and changing these trend lines. But I think it’s important at the outset to define the breadth of the problem. 

Unfortunately, the brief list I just offered is by no means exhaustive.  But in listing these topics, it underscores the challenges faced by these communities and the critical role that the specific subjects of your discussions today will play in addressing these broader challenges. 

Consider, for instance, the opportunities offered by technologies, such as telemedicine. Thanks to remarkable advances in technology, we have many new and innovative pathways to improve health and health care delivery – offering enormous promise for patients, consumers, and health care professionals isolated by the consequences of their geographical location.

Digital health solutions offer a range of support, from better management of personal health and wellness, more timely access to important medical information, and improved connections between patients and medical professionals for evaluations and diagnoses outside of traditional health care settings.  

FDA increasingly has focused on this issue, working to make sure that the best available science and technology is harnessed for the benefit of consumers, patients, and healthcare providers.  These are important components of our efforts to be modern and efficient, including our digital health innovation plan, which seeks to foster innovation at the intersection of medicine and digital health technology, and offers enormous opportunities for the unique situation of residents of rural communities.  FDA’s goal is to be as forward-leaning as possible, by providing the policies and regulatory tools that spur and support innovation in medical technology. These medical technologies can alleviate some of the challenges rural communities are facing getting access to care because of their geographic location.

The second topic on your agenda is rural tobacco use. There has been progress since the Surgeon General’s 1964 report on tobacco use, but we still see the significant public health toll tobacco use takes, especially in our nation’s rural communities.  

Among the distressing issues is the disparity between rural and urban tobacco use.  Smokers living in rural areas are more likely to smoke 15 or more cigarettes per day than smokers living in urban areas.  And rural residents are likely to have 18 to 20 percent higher rates of lung cancer than people living in urban areas.  Perhaps most concerning are the statistics for the most vulnerable – young people. Adolescents in rural regions begin smoking cigarettes earlier in life, and are more likely to smoke on a daily basis than adolescents in suburban and urban areas.

As with smoking, smokeless tobacco use disparities among rural population present another concerning trend.  Indeed, smokeless tobacco is more than twice as likely to be used in rural areas compared to metropolitan areas in the United States.  According to the most recent data from the FDA’s Population Assessment of Tobacco and Health study, nearly 32 percent of rural, white males from 12 to 17 years of age are either currently experimenting with, or susceptible, to using smokeless tobacco.  To get an idea of the magnitude of the problem, each day in the U.S., nearly 1,000 males under the age of 18 use smokeless tobacco for the first time, almost as many male teenagers who smoke their first cigarette.

This is one reason why FDA last year expanded its “The Real Cost” public education campaign to include advertising targeting rural male youths from 12 to 17 years old in 35 local markets around the U.S.  The 35 markets were selected because they have the highest concentrations of young people who are considered most at risk of smokeless tobacco use.

The “Real Cost” campaign is only one of FDA’s initiatives regarding tobacco.  Earlier this year, Dr. Gottlieb announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.  The plan places nicotine, and the issue of addiction, at the center of the Agency’s tobacco regulation efforts.  In this way, we can help address these problems at their source, which ultimately will contribute to a decline in smoking, particularly among the most vulnerable individuals.

The final topic of today’s symposium addresses the current national health crisis of opioid addiction and abuse.  Some of the communities hardest hit by our nation’s tragic opioid crisis are those in rural America and Tribal communities.

Since becoming Commissioner, Dr. Gottlieb has made combatting the opioid crisis his number one priority at FDA.  We all recognize that FDA has an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.   Yesterday Dr. Gottlieb testified on Capitol Hill on this topic and how the FDA is working to address this epidemic and expressed the importance of Medication Assisted Treatment and embracing long term treatment options help people in their recovery. We are going to support innovation in this space by issuing guidance on use of novel, non-abstinence-based endpoints as a part of product development.

As he explained, we’re working across the full scope of our regulatory obligations on addressing this crisis. This includes:

- Updating and extending the risk management plans and educational requirements that we impose on sponsors as a condition of a product’s approval;

- Doubling our efforts to promote the development of new, less addictive pain remedies and alternative treatments for pain.  We know this will include non-opioid treatment alternatives as well as devices; and, 

- Updating our risk-benefit framework to take measure of the risks associated with misuse and abuse of opioids; and using this information to inform our decisions -- including recommending that products be withdrawn from the market.

We established an Opioid Policy Steering Committee to bring together some of FDA’s most senior leaders to explore and develop additional tools or strategies that the Agency can use to confront this crisis.  Dr. Gottlieb tasked this group with taking a fresh look at what additional steps we might pursue to confront this challenge in the hopes of helping to change the trajectory of this epidemic. The Committee will be looking at key features of the Agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs.

As I suggested at the outset, these three topics – the shortage of health care professionals, tobacco use by youth, and opioids – represent some of the major health care challenges faced by rural and Tribal communities.  I hope that through the discussions we have today, and the partnerships you create and enhance, we will collectively make continued progress in overcoming these challenges. 

Our mission at FDA is to protect and promote the public health.  I know that this is a shared mission with many of you here today and I want to thank you for your work to improve the quality of life for those in our rural and Tribal communities.  I wish you luck and I look forward to seeing the results.

Thank you.

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