We’re just over midway through the hazy days of summer vacation, and children without access to high quality enrichment opportunities are already slipping behind their wealthier peers. As noted in a recent New York Times article, in addition to the decrease in math proficiency that most kids experience over the break, low-income children also lose more than two months of reading skills—skills they don’t regain during the school year. This compounds the already deep educational disparities found among students of different socioeconomic groups, which can be observed as early as 18 months of age.

Most efforts to address these gaps focus on improving our K-12 educational systems. Yet, children spend an average of 80 percent of their waking time outside of a classroom—a simple, yet startling statistic that highlights the need to explore a broader range of solutions.

As we learned at a recent Brookings event, Urban Thinkscape, an ongoing project from developmental psychologists Kathy Hirsh-Pasek and Roberta Michnick Golinkoff, might be one of those solutions. Drawing on findings from their research on guided play—particularly from interventions like the Ultimate Block Party and The Supermarket Study—the project embeds playful learning activities, such as games and puzzles, into public places where children routinely spend time during non-school hours. Designed by architect Itai Palti, each installation is created with specific learning goals in mind and reflects best practices in psychological research.

With a pilot led by researcher Brenna Hassinger-Das in progress in the West Philadelphia Promise Zone, the project is already revealing important lessons—not only for educators, but for urban planners and policymakers as well.

The first involves the (often under-appreciated) need to work with local residents. Through meetings and focus groups with leaders of community organizations, neighbors, and Promise Zone stakeholders, the team gained a clearer understanding of resident needs, spurred interest in the project, identified potential sites, and improved designs. Residents were brought into the process early, empowered to offer suggestions at several stages, and will continue to be engaged as the project is implemented and assessed.

The upshot? When community members are meaningfully involved—and local wisdom valued—from the onset, residents become invested in the project and feel a sense of ownership of it over the long haul. This not only improves the likelihood that the project will succeed, but also helps foster neighborhood trust and cohesion, and builds social capital that can be applied to future efforts.

A second lesson is the extent to which a full scaling of the project could help transform distressed neighborhoods through what Project for Public Spaces often refers to as “lighter, quicker, cheaper” interventions.

Many high poverty urban areas are challenged with large numbers of vacant or underutilized properties, as well as dull spaces (like bus stops) that serve only utilitarian functions. The Urban Thinkscape project aims to take such spaces and remake them into opportunities for interaction and learning—and by doing so create tangible improvements to the neighborhood’s physical fabric. While the West Philadelphia pilot has substantial long-term planning behind it, ideally the “playful” installments will be refined over time so they can be more easily and cheaply implemented in other urban neighborhoods.

Finally, the Urban Thinkscape interventions have the potential to advance academic and spatial skills in children, reducing the gap in school readiness, and ultimately fostering better educational and life outcomes.

Many families in high poverty neighborhoods can’t afford extracurricular enrichment activities, particularly during the summer. And even where they might be offered—via community centers, or through other nonprofit initiatives focused on the arts, STEM activities, or sports—children may only experience them at certain times of the week. Urban Thinkscape aims to supplement these activities by embedding learning opportunities into the everyday landscape through interventions that develop numeracy, literacy, and other skills necessary to succeed in school and eventually the workforce. From an urban planning and policy perspective, this individual development is critical to helping build family wealth and vibrant, healthy city neighborhoods.

Though still nascent in its development, the Urban Thinkscape model appears to be a fun, innovative way to give children—and their caregivers—learning opportunities outside the classroom, while creating new gathering spaces and improved public places. In this way, the project is creatively employing the city itself as an agent of change. If the full vision of this work is realized, perhaps we can finally put the brakes on the “summer-slide” such that all kids can start the school year at the top of their game.

       

       

       

       

Abstract

We explore the relationship between agency and hedonic and evaluative dimensions of well-being, using data from the Gallup World Poll. We posit that individuals emphasize one well-being dimension over the other, depending on their agency. We test four hypotheses including whether: (i) positive levels of well-being in one dimension coexist with negative ones in another;and (ii) individuals place a different value on agency depending on their positions in the well-being and income distributions. We find that: (i) agency is more important to the evaluative well-being of respondents with more means; (ii) negative levels of hedonic well-being coexist with positive levels of evaluative well-being as people acquire agency; and (iii)both income and agency are less important to well-being at highest levels of the well-being distribution. We hope to contribute insight into one of the most complex and important components of well-being, namely,people’s capacity to pursue fulfilling lives.

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China’s meteoric rise lifted its economy but damaged its environment, and it has new aspirations to leadership on the global stage. Africa has enormous natural capital and is hungry for development. How can they collaborate? Their interests may intersect within a model of development that invests in natural capital instead of prizing only extraction.

On July 11th, the Brookings Tsinghua-Center, in collaboration with GreenPoint Group and School of Public Policy and Management at Tsinghua University, hosted the panel Sustainability within the China-Africa Relationship: Governance, Investment, and Natural Capital. The panel was moderated by SMPP Associate Professor and IMPA director Zheng Zhenqing, and featured Mr. Peter Seligmann, chairman and CEO of Conservation International; Professor Qi Ye, director of the Brookings Tsinghua-Center; Honorable Minister Anyaa Vohiri of the Environmental Protection Agency of Liberia; Professor Pang Xun, expert on official direct assistance and the politics of aid; and Mr. Rule Jimmy Opelo, Permanent Deputy Secretary of the Ministry of Environment, Wildlife and Tourism of Botswana.

Professor and Dean of School of Public Policy and Management Xue Lan gave the opening remarks, highlighting that both China and Africa face the challenge of balancing development and sustainability. Minister Vohiri then presented on the challenges and great potential of Africa's vast, untapped renewable energy resources before Professor Zheng opened the panel. Framing China and Africa as global partners with the common aspiration of growing sustainable, the panelists discussed the need for developing economies to recognize that the health of their environment is inseparable from the health of their economies.

Questions concerning the UN’s Sustainable Development Goals and Millennium Development goals presented conservation as a global issue requiring global governance. Mr. Seligmann forwarded the idea that sustainable development as enlightened self-interest has entered mainstream thought, asserting that the challenge now lies in crafting region-specific policies and plans of implementation. The importance of cooperation surfaced as a common theme. Mr. Opelo examined the possibilities of South-South cooperation, and Professor Qi provided a history for the emergence of natural capital as a concept before underlining the need for government to collaborate with civil society and the private sector.

The highlighted benefits of Sino-African cooperation ranged from the greater political freedom afforded to aid recipient countries when there is donor competition to Africa's potential "leapfrog" development to a green economy if it obtains sufficient investment. Professor Qi spoke of the lessons provided by China’s evolution from a parochial developing country into the world’s leader in sustainable development. Professor Pang emphasized the benefits both to China and to African countries when the influence of conditional aid from the United States is diluted by Chinese competition. Minister Vohiri and Mr. Opelo discussed the challenges of balancing conservation enforcement with the provision of basic needs, concluding that China's capital and knowledge could help Africa develop its economy in a sustainable direction. The panelists closed by addressing questions from the audience that problematical transparency problems with China's current model of development in Africa, the sustainability of green energy subsidies, the threats of mining and poaching, and Africa's role in addressing a global environmental crisis to which it largely did not contribute.

Xue Lan gave the opening remarks

Minister Vohiri delivered keynote remarks

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On the invitation of House Speaker Paul Ryan, who stated that “[t]he friendship between the United States and India is a pillar of stability in an important region of the world,” Indian Prime Minister Narendra Modi will be addressing a joint meeting of the U.S. Congress on June 8. There have been five Indian prime ministers who’ve given such remarks: Jawaharlal Nehru (1949, to separate House and Senate gatherings), Rajiv Gandhi (1985), P.V. Narashima Rao (1994), Atal Bihari Vajpayee (2000) and Manmohan Singh (2005). Their speeches were reflective of the contemporary global context and the state of the U.S.-India relationship, but they did share some themes as well. Modi will likely emphasize that he is transforming India (as these other prime ministers asserted as well) and want to highlight the change he is bringing, but his speech might also echo some of these past themes. Below is a look back at what India’s prime ministers have said to Congress—a past glimpse that is also instructive in terms of how much the U.S.-India relationship has changed.

On October 13, 1949, two years of India’s independence (and a few days after the communists had taken over China), Jawaharlal Nehru addressed back-to-back meetings of the House and Senate. Declaring that “Nehru puts India on freedom’s side,” The New York Times noted in a front-page story that "Pandit Nehru expressed pride for India's past, hope for her future, but acute awareness of her present economic difficulties."

On June 13, 1985, Rajiv Gandhi, Nehru’s grandson who had won a major electoral victory the previous year, became the first Indian premier to address a joint meeting of Congress. In an above-the-fold story featuring a photo of a smiling Gandhi, Vice President George H.W. Bush and House Speaker Tip O’ Neill, The New York Times particularly remarked on the 40-year-old prime minister’s youthfulness and remarks on Afghanistan.

On May 18, 1994, a few years after the collapse of the Soviet Union and after having introduced a wave of economic reforms, P.V. Narasimha Rao addressed Congress. Ten days before that The New York Times featured a story on his finance minister Manmohan Singh and the reforms the two leaders were undertaking. Reflecting the relative disinterest in India in the U.S. at the time, the Times did not, however, cover Rao’s speech.

On September 14, 2000, Atal Bihari Vajpayee, India’s first prime minister from the Bharatiya Janata Party (BJP) addressed the U.S. Congress. His two years in power till then had seen India conduct nuclear tests, a crisis with Pakistan seen as a turning point in U.S.-India relations because the U.S. called out Pakistan for its actions, and a U.S. presidential visit to India after two decades. A jovial photo of the prime minister and President Clinton made the front page a couple of days later, but the speech itself did not get coverage in the newspaper of record.

On July 19, 2005, Manmohan Singh, who’d just reached a civil nuclear agreement with President Bush, addressed Congress. His visit—and that agreement—received front-page coverage, but the speech itself was not covered separately.

In his speech, Prime Minister Modi will likely stress the challenge that terrorism poses globally and regionally, and highlight U.S.-India the counter-terrorism cooperation. The last three Indian premiers have addressed this challenge as well.

President Obama reiterated U.S. support for Indian membership of the Nuclear Suppliers Group and encouraged other members to welcome Indian into the group. The U.S. and India have come a long way on a subject that has come up in every prime minister’s speech since Rajiv Gandhi.

Every prime minister has outlined their economic policy objectives and achievements—more recent ones, have highlighted the opportunity India represents. While this was the focus of Modi’s speech to the U.S.-India Business Council, expect this to be a subject he covers in his remarks to Congress as well.

Indian prime ministers have seen the U.S. as a crucial source of technology, and often made the case for technological assistance or transfers or collaboration.

There has also been the linkage between democracy and development in various ways: highlighting the development task India is undertaking in a democratic context, stressing that democracies are better placed over the long-run to innovate and develop equitably, and suggesting that the U.S. has an interest in helping India’s democratic experiment—now democratic engine—succeed.

Whether to address concerns in Congress, note the similarities between India and the U.S., or stress India’s multi-cultural, multi-ethnic, multi-lingual and multi-religious nature, each prime minister has talked about diversity, equality and freedom.

In their speeches, each of the prime ministers have noted the contributions of the growing numbers of Indian-Americans and non-resident Indians in the United States. Modi has made the diaspora a key focus; expect him to emphasize its role.

A week before his speech to Congress, Vajpayee famously asserted that “India and the USA are natural allies.” He’s not the only one to have noted the “natural” character of the relationship, though there’s been different reasoning behind that assertion or hope.

       

       

Editor’s Note: The following chapter is part of the report, "After the Drug Wars," published in February 2016 by the London School of Economics and Political Science's Expert Group on the Economics of Drug Policy.

Even as the administration of Mexico’s President Enrique Peña Nieto has scored important reform successes in the economic sphere, its security and law enforcement policy toward organized crime remains incomplete and ill-defined. Despite the early commitments of his administration to focus on reducing drug violence, combating corruption, and redesigning counternarcotics policies, little significant progress has been achieved. Major human rights violations related to the drug violence, whether perpetrated by organized crime groups or military and police forces, persist – such as at Iguala, Guerrero, where 43 students were abducted by a cabal of local government officials, police forces and organized crime groups. This has also been seen in Tatlaya and Tanhuato, Michoacán, where military forces have likely been engaged in extrajudicial killings of tens of people. Meanwhile, although drug violence has abated in the north of the country, such as in Ciudad Juárez, Monterrey and Tijuana, government policies have played only a minor role. Much of the violence reduction is the result of the vulnerable and unsatisfactory narcopeace – the victory of the Sinaloa or Gulf Cartels. 

The July 2015 spectacular escape of the leader of the Sinaloa Cartel and the world’s most notorious drug trafficker – Joaquín Guzmán Loera, known as El Chapo – from a Mexican high-security prison was a massive embarrassment for the Peña Nieto government. Yet it serves as another reminder of the deep structural deficiencies of Mexico’s law enforcement and rule-of law system which persists more than a decade after Mexico declared its war on the drug cartels.

The Peña Nieto administration often pointed to the February 2014 capture of El Chapo as the symbol of its effectiveness in fighting drug cartels and violent criminal groups in Mexico. The Peña Nieto administration’s highlighting of Chapo’s capture was both ironic and revealing: ironic, because the new government came into office criticizing the anti-crime policy of the previous administration of Felipe Calderón of killing or capturing top capos to decapitate their cartels; and revealing, because despite the limitations and outright counterproductive effects of this high-value-targeting policy and despite promises of a very different strategy, the Peña Nieto administration fell back into relying on the pre-existing approach. In fact, such high-value-targeting has been at the core of Pena Nieto’s anti-crime policy. Moreover, Chapo’s escape from Mexico’s most secure prison through a sophisticated tunnel (a method he had also pioneered for smuggling drugs and previously used for escapes) showed the laxity and perhaps complicity at the prison, and again spotlighted the continuing inadequate state of Mexico’s corrections system.

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The special election in California and the beginning of the recall process in Wisconsin are only the start of what promises to a be a hyper-partisan election. On July 13, Thomas Mann answered your questions on the new forces at work in the political landscape, in a live web chat moderated by POLITICO Senior Editor David Mark.

The transcript of this chat follows.

David Mark: Welcome to the chat, let's get started.

12:30 Comment From Brooke: Were you surprised by the results of California's special election?

12:32 Tom Mann: No, Hahn's 10 point victory was expected. This was less than the natural Democratic strength of the district and reflected the generously self-funded opposition campaign.

12:32 Comment From Travis: What's the significance of that CA seat remaining Democrat?

12:34 Tom Mann: Not much in the way of national significance. If anything, it's a step back for the Democrats, who in the last, NY special in a Republican district, pulled off a genuine upset, running substantially ahead of Obama and the party registration. But the Democrats avoided an upset in California, which would have been discouraging and distracting to them.

12:34 Comment From Yan: Can you explain what's going on in Wisconsin?

12:39 Tom Mann: No!! It's been a crazy year in my home state. Yesterday's six elections were not for real. They had fake Democratic candidates challenging the slated Democrats solely to delay the actual recall elections by a month. All of the "real" Democrats won and three or four of them have a good chance to defeat the incumbent Republican state senators on August. Next week on July 19 three Democratic incumbents will be on the ballot -- two facing fake candidates but one facing a Republican challenger. The latter is important, as are the August 16 elections featuring the other two Democratic incumbents. Bottom line-- Democrats need a net gain of three seats to take control of the State Senate and slow Governor Walker's agenda. Turnout was relatively high yesterday and control of the State Senate is genuinely up for grabs.

12:39 David Mark: Realizing that the lines aren't final, what's your sense about how effective the independent California redistricting commission has been in drawing districts that are potentially more competitive?

12:42 Tom Mann: It appears they have been successful in increasing the number of competitive districts. At the same time, they have boosted Democratic prospects for a seat gain and disappointed Hispanics who feel that their population growth in the state has not been reflected in the Commission's maps. I suspect some significant revision in the plans that are finally released by the Commission and if necessary, an appeal to the courts.

12:42 Comment From Henry: What do you expect from the next election cycle?

12:47 Tom Mann: I believe the presidency and control of both House and Senate are up for grabs. It will be a very high stakes election with huge warchests. (Obama and the DNC together raised $86 million in the second quarter, which dwarfs what the Republican candidates combined have raised.) But both parties will be well-funded in the presidential and congressional races. At this point, I'd say Obama probably has the best prospect of winning; same is true of Republicans taking the Senate and holding the House. But it is early; the economic climate remains volatile; and events could overwhelm the present situation.

12:47 Comment From Danny (MD): What kind of a role do you see Super PACs playing in the next round of elections?

12:50 Tom Mann: The SuperPacs and their affiliated 501c organizations will be major players in the 2012 elections. Disclosure of donors will continue to diminish and large corporate and individual contributions will support extensive independent spending campaigns. Democrats have decided to follow the Republicans rather than fight them on campaign finance reform.

12:50 Comment From Danny (MD):What do you think about Stephen Colbert's Super PAC?

12:52 Tom Mann: Colbert is being Colbert. With his trusted legal advisor Trevor Potter, he is creating the PAC and testing the rules to educate the public about the inadequacy of campaign finance law and regulation. Political satire may be one of the more effective means of pushing political reform.

12:52 Comment From Bill in Va.: Beyond the immediate results of elections in California and Wisconsin, there are new laws in a lot of swing states that will seem to make it harder for certain people to cast their vote. Will these laws stand, or be challenged, and can they have an impact in the 2012 outcome?

12:56 Tom Mann: Election law in the States has sadly become yet another tool of partisan war. New voter ID laws have been passed in states controlled by Republicans but not in the others. I expect Democrats will gear up at the grassroots level to try to contest any efforts to deny access to the ballot of any of their legitimate voters. It all makes one yearn for the Australian compulsory voting system. Giving parties the incentive to depress turnout is downright depressing.

12:57 Comment From Ron: Just to step back from the specifics for a moment, how do you explain the very nasty tone of our politics these days...and what will it take to return some civility to the process?

1:00 Tom Mann: I'm not looking for civility any time soon. The ideological polarization of the parties and the partisan team play that now characterizes our politics and governance is deeply rooted in American society and reinforced by the new media. The populist Tea Party, with its certainty and righteous indignation, has been embraced by the Republicans in Washington and makes it almost impossible for politicians on opposite sides of the aisle to treat one another respectfully and work toward compromise.

1:00 David Mark: Thanks for the chat, everybody.

 

       

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.

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Read the Related Report: Job Sprawl and the Suburbanization of Poverty »

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Recent events in Taiwan, including the Sunflower Movement and the November 29 municipal elections in 2014, indicate changes in Taiwan’s political landscape. Political parties and candidates will have to adjust to changing public opinion and political trends as the January 2016 presidential and legislative elections approach. The two main parties, the Kuomintang (KMT) and the Democratic Progressive Party (DPP), face both opportunities and challenges in disseminating their messages and garnering public support. The strategies that each party develops in order to capture the necessary votes and seats will be critical. 

On April 22, the Center for East Asia Policy Studies at Brookings and Freeman Chair in China Studies at the Center for Strategic and International Studies co-hosted a public forum to identify and analyze the politics behind the 2016 elections in Taiwan. Leading experts from Taiwan and the United States assessed the new forces and phenomena within Taiwan politics; how the election system itself may contribute to election outcomes, especially for the Legislative Yuan; and how the major parties must respond to emerging trends.

 

 Join the conversation on Twitter at #TaiwanElections

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Strong Growth and Changing Composition 

External financial flows to sub-Saharan Africa (defined as the sum of gross private capital flows, official development assistance (ODA), and remittances to the region) have not only grown rapidly since 1990, but their composition has also changed significantly. The volume of external flows to the region increased from $20 billion in 1990 to above $120 billion in 2012. Most of this increase in external flows to sub-Saharan Africa can be attributed to the increase in private capital flows and the growth of remittances, especially since 2005 (see Figure 1).

Figure 1. Sub-Saharan Africa: External Flows (1990-2012, in USD billions)

As also displayed in Figure 1, in 1990 the composition of external flows to sub-Saharan Africa was about 62 percent ODA, 31 percent gross inflows from the private sector, and about 7 percent remittances. However, by 2012, ODA accounted for about 22 percent of external flows to Africa, a share comparable to that of remittances (24 percent) and less than half the share of gross private capital flows (54 percent). Also notably, in 1990, FDI flows were greater than ODA flows in only two countries (Liberia and Nigeria) in sub-Saharan Africa excluding South Africa, but 22 years later, 17 countries received more FDI than ODA in 2012—suggesting that sub-Saharan African countries are increasingly becoming less aid dependent (see Figure 2).

Figure 2. Sub-Saharan Africa: Number of Countries Where FDI is Greater than ODA (1990-2012)

But to what extent have these changes in the scale and composition of external flows to sub-Saharan Africa equally benefited countries in the region? Did the rising tide lift all boats? Is aid really dying? Are all countries attracting private capital flows and benefiting from remittances to the same degree? Finally, how does external finance compare with domestic finance? 

The False Demise of ODA

A closer look at the data indicates that, clearly, ODA is not dead, though its role is changing. For instance, middle-income countries (MICs) are experiencing the sharpest decline in ODA as a share of total external flows to the region, while aid flows account for more than half of external flows in fragile as well as low-income countries (LICs) and resource-poor landlocked countries (see Figure 3 and Appendix).

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The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness that demonstrate “substantial improvement” over existing therapies. The program has since become a widely supported mechanism for accelerating patient access to new drugs. As of March 2015, FDA has received a total of 293 requests for BTD. However, it has granted just  82 (28%), which indicates an ongoing lack of clarity over what exactly meets the criteria for the designation.

On April 24, the Center for Health Policy at Brookings convened a public meeting to explore the designation’s qualifying criteria and how FDA applies those criteria across therapeutic areas. Panelists used real-world and hypothetical case studies to frame the discussion, and highlighted major considerations for the application process, the FDA’s evaluation of the evidence, and the key factors for acceptance or rejection. The discussion also identified strategies to ensure that qualifying criteria are well understood. Here are the five big takeaways:

1.  The BTD program is viewed positively by drug companies, researchers, advocates, and others 

Across the board, participants expressed enthusiasm for the BTD program. Industry representatives noted that their experience had been extremely positive, and that the increased cooperation with and guidance from FDA were very helpful in streamlining their development programs. Receiving the designation can also raise a drug company’s profile, which can facilitate additional investment as well as clinical trial patient recruitment; this is particularly important for smaller companies with limited resources.

Patient and disease advocates were likewise supportive, and expressed hope that the early lessons learned from successful breakthrough therapy approvals (which have been mostly concentrated in the oncology and antiviral fields) could be translated to other disease areas with less success. However, while BTD is an important tool in expediting the development of new drugs, it is just one piece of broader scientific and regulatory policy landscape. Accelerating the pace of discovery and development of truly innovative new drugs will depend on a range of other factors, such as developing and validating new biomarkers that can be used to measure treatment effects at an earlier stage, as well as establishing networks that can streamline the clinical trial process. It will also be important to develop effective new approaches to collecting, analyzing, and communicating information about these treatments once they are on the market, as this information can potentially be used by FDA, providers, and patients to  further improve prescription drug policy and medical decision-making.

2.  BTD requests far outnumber those that actually meet the qualifying criteria

Since the program began, less than 30 percent of requests have received BTD designation. A substantial majority were denied at least in part due to either a lack of data or problems with the quality of the data, or some combination of the two. For example, some sponsors requested the designation before they had any clinical data, or submitted the request using clinical data that was incomplete or based on flawed study designs. Many requests also failed to meet the Agency’s bar for “substantial improvement” over existing therapies.

One reason for the high denial rate may be a lack of a clear regulatory or statutory bar that could be used as a definitive guide for sponsors to know what is needed to qualify for the designation. BTD denials are also confidential, which means that sponsors effectively have nothing to lose by submitting a request. Going forward, manufacturers may need to exercise more discretion in deciding to request the designation, as the process can be resource- and time-intensive for both sides.

3.  There is no single threshold for determining what defines a breakthrough therapy

About 53 percent of the 109 total BTD denials were due at least in part to the fact that the drug did not represent a substantial improvement over existing therapies. During the day’s discussion, FDA and sponsors both noted that this is likely because the criteria for BTD are inherently subjective. In practice, this means there is no clear threshold for determining when a new therapy represents a “substantial improvement” over existing therapies. Designation decisions are complex and highly dependent on the context, including the disease or condition being targeted, the availability of other treatments, the patient population, the outcomes being studied, and the overall reliability of the data submitted. Given the multiple factors at play, it can be difficult in some cases to determine when a new product is potentially “transformational” as opposed to “better,” especially for conditions that are poorly understood or have few or no existing treatments. In making its determinations, FDA considers the totality of the evidence submitted, rather than focusing on specific evidentiary requirements.

4.  Early communication with FDA is strongly recommended for BTD applicants

Roughly 72 percent of the BTD denials related at least in part to trial design or analysis problems, which led several people to suggest that sponsors engage with FDA prior to submitting their request. Though there are several formal mechanisms for interacting with the agency, informal consultations with the relevant review division could help sponsors to get a better  and much earlier sense of what kind of data FDA might need. This early communication could both strengthen viable BTD requests and reduce the number of frivolous requests.

5.  FDA may need more resources for implementing the BTD program

Drugs that receive breakthrough designation are subject to much more intensive FDA guidance and review. However, when the program was established in 2012, Congress did not allocate funding to cover its costs. There have been ongoing concerns that the program is exacting a significant toll on FDA’s already limited resources, and potentially affecting the timeline for other drug application reviews. These concerns were reiterated during the day’s discussion, and some suggested that Congress consider attaching a user fee to the BTD program when the Prescription Drug User Fee Act comes up for reauthorization in 2017.

      

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The biomedical innovation ecosystem continues to evolve and enhance the processes by which treatments are developed and delivered to patients. Given this changing biomedical innovation landscape, it is imperative that all stakeholders work to ensure that development programs, regulatory practices, and the policies that enable them are aligned on and achieving a common set of goals. This will require a thorough reexamination of our understanding of biomedical innovation – and the subsequent ways in which we seek to incentivize it – in order to more effectively bridge research and analysis of the process itself with the science and policy underpinning it.

Traditional research into the efficiency and effectiveness of drug development programs has tended to focus on the ‘inputs’ and process trends in product development, quantifying the innovation as discrete units. At the opposite end of the research spectrum are potential measures that could be categorized as “value” or “outcomes” metrics. Identifying the appropriate measures across this spectrum – from inputs and technological progress through outcomes and value – and how such metrics can be in conversation with each other to improve the innovation process will be the focus of this expert workshop. On October 14, the Center for Health Policy at Brookings, under a cooperative agreement with the U.S. Food and Drug Administration, convened a roundtable discussion that engaged key stakeholders from throughout the innovation ecosystem to explore the factors and characteristics that could improve our understanding of what constitutes modern “innovation” and how best to track its progress.

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EXECUTIVE SUMMARY

Fragile states present one of the greatest challenges to global development and poverty reduction. Despite much new learning that has emerged from within the development community in recent years, understanding of how to address fragility remains modest. There is growing recognition that donor engagement in fragile states must look beyond the confines of the traditional aid effectiveness agenda if it is to achieve its intended objectives, which include statebuilding, meeting the needs of citizens, and managing risk more effectively. Current approaches are constrained by relying heavily on small-scale interventions, are weakened by poor coordination and volatility, and struggle to promote an appropriate role for the recipient state.

Scaling up (i.e., the expansion, replication, adaption and sustaining of successful policies and programs in space and over time to reach a greater number of people) is highly relevant to fragile settings, both as an objective and as a strategic approach to development. As an objective, it reinforces the logic that the scale of the challenges in fragile states demands interventions that are commensurate in purpose and equal to the task. As a strategy, it encourages donors to identify and leverage successes, and to integrate institutional development more explicitly into projects and programs. In addition, scaling up can assist donors in addressing the priority areas of improved project design and implementation, sustainability and effective risk management.

Successful scaling up in fragile states almost certainly occurs less often than is possible and does not always involve a systematic approach. Donors should therefore look to more systematically pursue scaling up in fragile states and evaluate their performance with specific reference to this objective. This can be done by incorporating relevant elements of a scaling up framework into operational policies, from strategy development through to program design and monitoring.

Contrary to expectations, there are compelling examples of successful scaling up in fragile states. While the conditions prevailing in fragile states create serious obstacles in terms of “drivers” (the forces that push the scaling up process forward) and “spaces” (the opportunities that need to be created, or potential obstacles that need to be removed for interventions to grow), and in terms of the operational modalities of donors, these can be overcome through the careful design and delivery of programs with a clear focus on creating scaling up pathways, and through close partnership and sustained engagement of governments, communities and foreign partners.

Case study evidence suggests that the pathways taken to reach scale in fragile states demand different approaches by donors. Donors need to adopt greater selectivity in determining which areas or sectors for scaling up are justified—a strategy that has also assisted some donors in managing risk. More investment and time are required in upfront analysis and building the evidence for successful scaling up pathways. In some cases, donors require longer time horizons to achieve scale, although demand from government or beneficiaries has sometimes forced donors to move immediately to scale, allowing little or no time for piloting. Regardless of the pace of scaling up, donors that were most successful were engaged early and then remained engaged, often far beyond the replication phase of scaling up, to increase the likelihood of interventions being sustained. Other common characteristics of successful scaling up were simple project design and a focus on the institutional aspects of the scaling up pathway.

Case studies also point to the crucial role of drivers in moving the scaling up process forward in fragile states. Proven ideas and practical models have often been picked up in fragile states, contrary to the expectation that actors may be less responsive to recognizing and acting on the utility of promising results. Leaders undoubtedly have a role to play in supporting scaling up, although there are clear dangers that must be avoided, including avoiding the perception that donors are picking (political) winners by nominating leaders, and tying the survival of projects too closely to the fortunes of a leader’s political career. Incentives were found to be one of the most important drivers in fragile states, and there is a good case to be made for donors introducing new inducements, greater transparency or similar reforms to strengthen the role incentives play. Finally, and in contrast to the standard scaling up framework, community demand was found to be an important driver in many fragile states, both in demanding the expansion of small-scale projects and by facilitating the community’s own resources to support the scaling up process.

The greatest challenge to scaling up in fragile states is the limited spaces these environments provide. This is especially the case in respect to those spaces which concern aspects of governance: political, institutional and policy spaces. When working in fragile states, donors must recognize that spaces for scaling up are almost always more constrained, but look for ways to expand upon them. Some of the most successful examples of scaling up used creative approaches to build space quickly or used existing capacity to the fullest possible extent. Also relevant are the lessons of robust analysis, greater realism and cost control. The case studies confirm the importance of two additional spaces in fragile states. For example, security space often imposed horizontal obstacles to scaling up which could not realistically be overcome while ownership space served as a good indication of the perceived legitimacy of the scaling up process and the likelihood that interventions would be sustained longer term.

Case studies also affirm the importance of emphasizing robust project design and implementation, and the close linkages between the scaling up agenda and the role of risk management and sustainability in fragile states. While sustainability presented a significant problem for many of the projects and programs reviewed, a more focused approach around scaling up may assist donors in addressing sustainability concerns. This would entail adopting a longer-term perspective beyond the immediate confines of any individual project, looking for available drivers and supportive spaces, and focusing on effective implementation and consistent monitoring and evaluation (M&E). Any intervention introduced on a small scale that scores well in sustainability serves as a possible candidate for scaling up.

Similarly, many of the methods used by donors for managing risk—an emphasis on analysis, scenario planning, realism and making use of specialized aid instruments—are equally relevant for supporting scaling up in fragile countries. A persuasive argument can be made that the adoption of a more explicit scaling up approach by donors can form part of a risk management strategy in fragile states. Scaling up can enable donors to more ambitiously tackle development risks without allowing institutional and project risks to grow unchecked. Ultimately, a donor approach that combines good risk management and scaling up requires strong leadership and well-aligned incentives.

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