The growth of suburban poverty over the past two decades raises questions about the ability of nonprofit organizations to adapt to this relatively new geography of metropolitan poverty. These organizations play multiple roles, including providing basic safety net services, connecting residents to new opportunities, and serving as advocates (and sometimes as organizers) for low-income communities.

Although federal, state, and local governments are often the primary funders of nonprofits, governments do not often take the lead in creating new organizational capacities or in coordinating capacity across political jurisdictions. In many regions, the local philanthropic community has become aware of these gaps in services for the poor and has sought to assist the nonprofit community in building capacity and expanding activities. Local foundations are experimenting with various strategies to address the growing dispersion of poverty.

This analysis combines an original data set of foundation grants for social services with in-depth interviews to assess the role of foundations in supporting the suburban social safety net in the Atlanta, Chicago, Denver, and Detroit regions. It finds that:

Suburban community foundations in the four regions studied are newer and smaller than those in core cities, despite faster growth of suburban poor populations. In the regions studied, most suburban community foundations began operating in the 1990s, and have not accumulated significant asset bases. Some larger city-based foundations have taken a regional approach, but face restrictions on the extent to which they can address growing need in poor suburban communities.

The share of foundation dollars targeted to organizations serving low-income residents varies widely across regions, but relatively few of those dollars are devoted to building organizational capacity in the suburbs. Chicago saw the largest share of foundation grant dollars go to organizations serving low-income people (60 percent), while Atlanta posted the lowest share (19 percent). Detroit was the only region where total grants to suburban-based human service providers were relatively comparable to their city-based counterparts.

Suburbs with high rates of poverty have substantially fewer grantees and grant dollars per poor person than either central cities or lower-poverty suburbs. Though metropolitan Atlanta has the highest rate of suburban poverty among the regions studied, it has the lowest rate of suburban grant-making per poor person. Denver’s results are a mirror image of Atlanta’s, with the lowest poverty rate and highest suburban grant-making per poor person.

Four types of strategies to build and strengthen the capacity of the suburban safety net are showing promise in these regions. Each region is engaging in four types of capacity building strategies: supporting existing regional organizations, creating new regional organizations, supporting regional networks, and establishing new suburban community foundations.

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An important federal program that tends to fly under the radar received some unprecedented real estate this past weekend--an enormous spread on page A1 of Sunday’s New York Times.

Jason DeParle’s article, and some nifty interactive maps on the Times website, portray the recent rapid growth of the food stamp program, now officially known as the Supplemental Nutrition Assistance Program, or by its rather unfortunate acronym, SNAP. DeParle documents how, in the wake of welfare reform in the mid-1990s, successive administrations--from Clinton to Bush, and now Obama--have worked in a bipartisan fashion to erase the stigma that once haunted the program, and ensure that eligible families receive access to its benefits.

Because welfare reform transformed what was an individual entitlement into a block grant to states, cash welfare caseloads in many states have remained relatively flat despite the worst recession in generations. As a result, food stamps--which remain a federal entitlement--have become an even more important countercyclical tool for fighting poverty, and enrollment has expanded by about one-third since 2007. DeParle charts that rise over the past two years across a broad cross-section of U.S. communities, all of which are feeling the economic pain of rising foreclosures, mounting job losses, and declining family incomes.

Of particular note, the article discusses the significant increases in food stamp receipt occurring in many suburban communities, now that a majority of the nation’s metropolitan poor live outside central cities. Indeed, the counties in which food stamp receipt has doubled, and which have at least 5,000 recipients today, are largely suburbs--around Atlanta, Florida’s Gulf Coast, Austin, and Youngstown. As my colleagues Elizabeth Kneebone and Emily Garr reported earlier this year, however, increases in food stamp enrollment in outer suburban counties have been somewhat lower than might be expected based on the rapid unemployment increases they have suffered. Lack of familiarity, distance to the nearest welfare office, stigma, or real eligibility differences may be to blame for under-enrollment in these farther-out areas.

All of which is to say, as food stamps become the de facto federal support system for millions of families during the next few years of elevated unemployment, plugging participation gaps in suburbia may be an important new frontier for fighting hunger and poverty in America.

      

Two years after the country entered the Great Recession, there are signs the national economy has slowly begun to recover. Thus far recovery has meant the return of economic growth, but not the return of jobs. And just as some communities have felt the downturn more than others, recovery has not and will not be shared equally across the nation’s diverse metropolitan economies.

Within metropolitan areas, many communities continue to struggle with high unemployment and increasing economic and fiscal challenges, while at the same time poverty and the need for emergency and support services continue to rise. Even under the best case scenario of a sustained and robust recovery, cities and suburbs throughout the nation will be dealing with the social and economic aftermath of such a deep and lengthy recession for some time to come.

An analysis of unemployment, initial Unemployment Insurance claims, and receipt of Supplementary Nutritional Assistance Program (SNAP, formerly known as food stamps) benefits in urban and suburban communities over the course of the Great Recession reveals that:

• Between December 2007 and December 2009, city and suburban unemployment rates in large metro areas increased by roughly the same degree (5.1 versus 4.8 percentage points, respectively). By December 2009, the gap between city and suburban unemployment rates was one percentage point (10.3 percent versus 9.3 percent)—smaller than 24 months after the start of the first recession of the decade (1.7 percentage points) and the downturn in the early 1990s (2.2 percentage points).
  
  
• Western metro areas exhibited the greatest increases in city and suburban unemployment rates—5.8 and 5.6 percentage points—over the two-year period ending in December of 2009. Increases in unemployment rates tilted more toward primary cities in Northeastern metro areas (a 5.3 percentage-point increase versus 4.2 percentage points in the suburbs), while suburbs saw slightly larger increases in the South (5.0 versus 4.4 percentage points).
  
  
• Initial Unemployment Insurance (UI) claims increased considerably between December 2007 and December 2009 in urban and suburban areas alike. The largest increases in requests for UI occurred in the first year of the downturn—led by lower-density suburbs—with new claims beginning to taper off between December of 2008 and 2009.
  
  
• SNAP receipt increased steeply and steadily between January 2008 and July 2009 across both urban and suburban counties. Urban counties remain home to the largest number of SNAP recipients, though suburban counties saw enrollment increase at a slightly faster pace during the downturn—36.1 percent compared to 29.4 percent in urban counties.
  

Even as signs point to a tentative economic recovery for the nation, metropolitan areas throughout the country continue to struggle with high unemployment. Within these regions, the negative effects of this downturn—as measured by changes in unemployment and demand for safety net services—have been shared across cities and suburbs alike. Standardizing sub-state data collection and reporting across programs would better enable policymakers and services providers to effectively track indicators of recovery and need in the nation’s largest labor markets.

Read the Full Paper » (PDF)
Read the Related Report: Job Sprawl and the Suburbanization of Poverty »

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Food safety is not a problem unique to China, though it is certainly one of the country’s most pressing and persistent challenges. On April 28, 2016, the John L. Thornton China Center hosted a public event to discuss food safety in China and what new regulations might mean for consumers and businesses.

Revised food safety law a step in the right direction

China’s revised Food Safety Law, enacted in October 2015, is intended to strengthen the regulation of food companies in China and enhance oversight along the supply chain. The law imposes tougher consequences on violators of food safety regulations. The revised Food Safety Law is a step in the right direction, but improving food safety will require more than just new regulations. Greater inter-agency coordination is needed among the various government entities with regulatory responsibility for food safety, including the China Food and Drug Administration, the Ministry of Agriculture, the National Health and Planning Commission, and the General Administration of Quality Supervision, Inspection and Quarantine.

China has done relatively better in enforcing food safety and quality standards for its food exports than it has for its domestic food market. A disparity between export quality and what is found in local markets is not uncommon in developing countries. But after several large-scale food safety incidents, domestic Chinese consumers are now paying close attention to the quality of their food and are no longer willing to accept such a disparity. Setting and enforcing higher food safety standards domestically is important for maintaining public health and for increasing consumer confidence. The latter will take time but is an indispensable component of the consumption-driven economy that China seeks.

Industry consolidation needed

One of the biggest obstacles facing Chinese food safety regulators is a still-fragmented domestic food industry with many small players. The increase in regulatory requirements and inspections mandated by the new law will raise the costs of doing business and likely lead to industry consolidation, which would help make the domestic Chinese food industry more manageable from a regulatory perspective. Emerging trends that see consumers buying food products from small and perhaps unverified retailers online actually make the jobs of regulators more difficult. This is because products are harder to trace—and, if there is a problem, to recall—when transactions occur through nontraditional retail channels. Traceability is critical to ensuring food safety because it allows problematic food items to be identified. The responsible firm can then correct the situation and each actor in the supply chain can be held accountable.

The Chinese government is already supporting initiatives that aggregate production units at the farm level. These farmer production bases enable farmers to coordinate food production and marketing to larger retailers. Participating farms have been provided with safe pesticides and guidelines on pesticide application; they are also able to sell to large retailers directly. These direct farmer-retailer relationships allow for greater traceability and facilitate the spot-checking that is necessary for verification. This model holds promise for improving food safety, especially as it pertains to pesticide application, but it will need to be scaled up to have a meaningful impact on China’s domestic food market.

What can China learn from other countries?

Since China is not alone in facing food safety challenges, it can learn lessons from the experiences of other countries. According to Vivian Hoffmann of the International Food Policy Research Institute, “there are many ways in which the public sector can harness the capacity and energy of the private sector to make food safety regulation more efficient.” For instance, China could consider greater co-regulation, which is a strategy that involves the private sector in regulation. Allowing firms to give input when regulators are setting standards can help prevent situations where unattainable standards are either crippling for companies or just ignored altogether. Hoffman is clear to note that allowing firms to give input does not mean compromising on consumer safety. Rather, it would create a more transparent process that would allow companies time to work up to higher standards if necessary. Private companies could be involved in testing their own products, but verification testing would still be needed.

Open communication with consumers is also important. The risk-based approach to food safety, which is the international norm and which China has also adopted, entails a particular challenge: Sometimes what consumers think is the most dangerous aspect of the food supply is different from scientists’ perceptions and knowledge of risk. For example, scientists may focus on biological contaminants while consumers worry about pesticides and additives. The concerns of consumers should be taken into account when setting priorities, but experts also need to explain why their concerns may be different. Communication and transparency are essential for bridging this disconnect. Chenglin Liu of St. Mary’s School of Law similarly stresses transparency as a key ingredient in improving China’s food safety situation. Broader capacity building efforts—as it relates to rule of law, an independent judiciary, and independent journalism—will help improve the enforcement of regulations.

The country’s revised Food Safety Law is a step in the right direction, but it is not enough to resolve China’s food safety woes. Regulatory enforcement remains a challenge. Fortunately, it is by no means an insurmountable one. Vigilant consumers will continue to demand higher-quality and more-traceable food products, a trend that puts increasing pressure on regulators to enforce high standards and that also presents great opportunities for proactive businesses.

       

       

       

Many proposals to accelerate and improve medical product innovation and regulation focus on reforming the product development and regulatory review processes that occur before drugs and devices get to market. While important, such proposals alone do not fully recognize the broader opportunities that exist to learn more about the safety and effectiveness of drugs and devices after approval. As drugs and devices begin to be used in larger and more diverse populations and in more personalized clinical combinations, evidence from real-world use during routine patient care is increasingly important for accelerating innovation and improving regulation.

First, further evidence development from medical product use in large populations can allow providers to better target and treat individuals, precisely matching the right drug or device to the right patients. As genomic sequencing and other diagnostic technologies continue to improve, postmarket evidence development is critical to assessing the full range of genomic subtypes, comorbidities, patient characteristics and preferences, and other factors that may significantly affect the safety and effectiveness of drugs and devices. This information is often not available or population sizes are inadequate to characterize such subgroup differences in premarket randomized controlled trials.

Second, improved processes for generating postmarket data on medical products are necessary for fully realizing the intended effect of premarket reforms that expedite regulatory approval. The absence of a reliable postmarket system to follow up on potential safety or effectiveness issues means that potential signals or concerns must instead be addressed through additional premarket studies or through one-off postmarket evaluations that are more costly, slower, and likely to be less definitive than would be possible through a better-established infrastructure. As a result, the absence of better systems for generating postmarket evidence creates a barrier to more extensive use of premarket reforms to promote innovation.

These issues can be addressed through initiatives that combine targeted premarket reforms with postmarket steps to enhance innovation and improve evidence on safety and effectiveness throughout the life cycle of a drug or device. The ability to routinely capture clinically relevant electronic health data within our health care ecosystem is improving, increasingly allowing electronic health records, payer claims data, patient-reported data, and other relevant data to be leveraged for further research and innovation in care. Recent legislative proposals released by the House of Representatives’ 21st Century Cures effort acknowledge and seek to build on this progress in order to improve medical product research, development, and use. The initial Cures discussion draft included provisions for better, more systematic reporting of and access to clinical trials data; for increased access to Medicare claims data for research; and for FDA to promulgate guidance on the sources, analysis, and potential use of so-called Real World Evidence. These are potentially useful proposals that could contribute valuable data and methods to advancing the development of better treatments.

What remains a gap in the Cures proposals, however, is a more systematic approach to improving the availability of postmarket evidence. Such a systematic approach is possible now. Biomedical researchers and health care plans and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the potential for large-scale, systematic postmarket data collection. Building on these efforts could provide unprecedented evidence on how medical products perform in the real-world and on the course of underlying diseases that they are designed to treat, while still protecting patient privacy and confidentiality.

These and other postmarket data systems now hold the potential to contribute to public-private collaboration for improved population-based evidence on medical products on a wider scale. Action in the Cures initiative to unlock this potential will enable the legislation to achieve its intended effect of promoting quicker, more efficient development of effective, personalized treatments and cures.

What follows is a set of both short- and long-term proposals that would bolster the current systems for postmarket evidence development, create new mechanisms for generating postmarket data, and enable individual initiatives on evidence development to work together as part of a broad push toward a truly learning health care system.

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Event Information

The Sentinel System is a state of the art active surveillance system relying on a distributed data network to rapidly scale analysis of health care data collected from over 178 million patients nationwide. Sentinel is an important safety surveillance tool used by the U.S. Food and Drug Administration (FDA), and its underlying distributed data infrastructure is increasingly being recognized to have the potential to support the needs of diverse stakeholders including other public health agencies, health systems, regulated industry, and the clinical research enterprise. Despite Sentinel’s importance in safety surveillance, patients are largely unaware of Sentinel’s public health mission and commitment to protecting patient privacy. Therefore, it is both timely and critical to identify opportunities to raise awareness and build trust for Sentinel safety surveillance among patients, consumers, and the general public.

On June 23, the Center for Health Policy at Brookings, in collaboration with the FDA, hosted an expert workshop to discuss opportunities to raise awareness of the Sentinel System through improved communication to patients and consumers. Participants, including Sentinel Data Partners, patient focused organizations (e.g., consumer advocacy groups), experts in patient privacy, ethics, and health literacy, and representatives from the FDA explored possible opportunities where each stakeholder might be uniquely positioned to engage with patients, and how these communications could be designed and delivered effectively. Discussions from this workshop resulted in recommendations including a set of guiding principles, potential tools, and strategies to improve awareness of the Sentinel System, but more broadly, safety surveillance activities led by the FDA.

Event Materials

• Sentinel Engagement_Discussion Guide
• Engagement_Agenda
• Engagement_Participant List
• Engagement_Speaker BioSketches
• Engagement_Meeting Summary

       

Good afternoon Chair Ayotte, Ranking Member Cantwell, and Members of the Subcommittee. Thank you very much for the opportunity to testify today on the important topic of domestic unmanned aircraft systems (UAS).

I am a nonresident senior fellow in Governance Studies and the Center for Technology Innovation at the Brookings Institution. I am also a National Fellow at the Hoover Institution at Stanford, and a professor at UCLA, where I hold appointments in the Electrical Engineering Department and the Department of Public Policy. The views I am expressing here are my own, and do not necessarily represent those of the Brookings Institution, Stanford University or the University of California.

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When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S. 

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.  

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

• Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
• Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
• Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas. 

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations. 

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings. 

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry. 

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.

Video

• New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System