One of the unfortunate things about any new health concern is that the snake oil sales start immediately. There are far too many scumbags who see an opportunity to profit in a crisis. The COVID-19 outbreak is no exception.

These people represent a real danger to the public. People who promote unproven treatments can convince the public that they don't need to take the outbreak seriously, can lead to reckless behavior, and in the extreme can contribute directly to increased deaths as their victims rely on the snake oil instead of trusting healthcare providers.

In this setting, FDA and FTC enforcement is essential. We need vigorous enforcement from the authorities to stop the spread of misinformation. I'm glad to see FTC and FDA have already taken some action in this regard. I hope we'll see more.

Researchers, practitioners, and industry are frantically searching for any effective treatments. Currently, the science is unclear about whether any treatment works.

As I write this, there has been a lot of buzz around the possible effectiveness of an anti-malarial treatment, hydroxychloroquine sulfate. This is an already-approved drug being used for an unapproved indication, i.e., this is a classic off-label use of a product.

I have seen some misinformation in the media about off-label uses of products, so I thought it might be helpful to set out the background to all of this.

To bring a new drug to market, a company must submit a New Drug Application (NDA) to the FDA. Among other information, the NDA includes proposed labeling. The proposed labeling provides directions to healthcare providers explaining how to use the drug safely. That labeling sets out the proposed uses of the drug. The uses of the drug are known as the indications. Indications typically include a population, a condition, and the stage/severity of the condition (if applicable).

The FDA evaluates the NDA to determine whether the sponsor has demonstrated that the drug is safe and effective for the proposed indications. Assuming the sponsor meets the evidentiary burden, the FDA approves the proposed indications for the product.

After being approved by the FDA, sponsors may only promote their drugs for the specific indications approved by the Agency. Any other use of the product is "off-label" use.

Off-label use is NOT inherently bad, wrong, or evil; and off-label use of a drug is also not prohibited. The other evening I heard a television news segment where the expert commentator spoke of using drugs in violation of FDA's rules. That's wrong.

FDA does not regulate the practice of medicine, and physicians are, for the most part, able to prescribe drugs as they believe is appropriate to treat the patients they see.

But the sponsors are not permitted to promote their drugs for any uses other than those approved by the FDA. Importantly, there is no explicit prohibition in law against the promotion of unapproved uses. You won't, for example, find off-label promotion listed as one of the items that causes a drug to be misbranded. Instead, there are multiple legal theories about this prohibition and what exactly makes such promotion illegal, including the failure to include adequate directions for use in the labeling.

FDA has made it clear that it sees the continued prohibition of off-label promotion as essential to protect the public, despite some adverse judgments by some courts.

If a company learns of a new off-label use for a drug and wants to promote the drug for that use, the sponsor must conduct additional clinical trials to demonstrate that the drug is also safe and effective for that new use. After completing the clinical trials, the sponsor submits an sNDA (supplemental New Drug Application) to the Agency.

Assuming the Agency approves the sNDA, the label is updated to include the new indication, clinical trial data, additional instructions for use, etc., and the company is then able to promote the new use of the drug.

So, FDA doesn't have to DO anything to make the possible off-label treatments available, despite several prominent people calling on FDA to take action. The drug being suggested for off-label use is already on the market and can be used for this off-label use.

Why doesn't FDA simply approve the new use?

Because FDA doesn't know if the drug works.

When FDA evaluates an NDA or sNDA it weighs the risks and benefits of the drug for each specific proposed use. As FDA has repeatedly made clear, each specific proposed use requires a separate risk-benefit determination.

It is possible (even likely) that a drug that has been proven to be safe and effective for one use might not be either safe or effective for another use.

Indeed, one frequent criticism of off-label use of drugs is that there simply isn't sufficient evidence of effectiveness for many off-label uses.

And that in turns leads directly to why FDA's prohibition on off-label promotion is so important to protect the public health. Using treatments without evidence and promoting such treatments can make things worse.

FDA has the tools to act rapidly to approve new uses of a drug, but it is unwise to short-circuit the approval process, and it's irresponsible to hype an off-label use without sufficient evidence to demonstrate its efficacy.

      

Stephen was still a teenager on the north side of St. Louis when his dad, a police officer, was killed during a robbery in their neighborhood. Despite the trauma, Stephen later joined the police force to continue his dad’s legacy and commitment to safe and inclusive neighborhoods. But even before the fatal shooting of Michael Brown in Ferguson in 2014, Stephen (not his real name) yearned to right local wrongs through broader approaches. “The darkest forces weren’t necessarily the ones getting arrested,” he observed. “So I retired from the police force after 22 years, essentially to chase after a different type of perpetrator.” Wanting to focus on policies at multiple levels of government that “were causing the disparities that fueled increasing crime and violence in St. Louis,” Stephen pivoted to civil rights enforcement, tracking policy violations and innovations at a government agency in the St. Louis region.

I met Stephen in February while in St. Louis for a conference his agency organized on HUD’s recently strengthened Affirmatively Furthering Fair Housing (AFFH ) rule, which increases local accountability in promoting residential integration. He wasn’t a speaker at the event, but hearing his story reinforced the importance of combating the deeply entrenched and often invisible causes of segregation.

Recent events and new academic research, including landmark findings by Raj Chetty and colleagues testifying to the benefits of low-poverty neighborhoods for low-income kids, the updated AFFH rule, and the Supreme Court’s disparate impact decision upholding other tools to fight segregation have brought renewed attention to these challenges. Meanwhile, underlying these developments, poverty has failed to decline since the recession and, as recent Brookings research shows, has become more concentrated in neighborhoods of extreme poverty.

How can regional leaders and practitioners respond to these challenges? I was in St. Louis to discuss one part of the solution—advancing more mixed-income neighborhoods. In the Chicago region, our housing and community development-focused firm, BRicK Partners, is collaborating with the Chicago Metropolitan Agency for Planning (CMAP), the Illinois Housing Development Authority (IHDA), and 10 metropolitan Chicago public housing authorities, with support and leadership from HUD, to develop and operate the Regional Housing Initiative (RHI)

RHI is a small, systemic, and potentially scalable “work around” of a very specific set of programs and policies that contribute inadvertently to regional inequities. A flexible and regional pool of resources working across the many traditional public housing authority (PHA) and municipal jurisdictions in the Chicago region, RHI increases quality rental housing in neighborhoods with good jobs, schools, and transit access and provides more housing options to households on Housing Choice Voucher (HCV) waiting lists. Recognizing that the federal formulas allocating HCVs to each individual PHA are not responsive to population, employment, or poverty trends, RHI partners convert and pool a small portion of their HCVs to provide place-based operating subsidies in support of development activity that advances local and regional priorities. RHI supports both opportunity areas with strong markets and quality amenities as well as revitalization areas where public and private sector partners are planning and investing toward that end. In both cases, the bulk of RHI investments are in the suburbs, where the PHAs are smaller and the rental stock more limited. 

RHI has committed over 550 RHI subsidies to nearly 40 mixed-income and supportive housing developments across Chicagoland, supporting more than 2,200 total apartments, over half of which are in opportunity areas. The pooling and transferring of subsidies has allowed RHI to support proposals that local jurisdictions wouldn’t be able to undertake otherwise.

Although a number of innovative programs around the country provide assistance to households moving to opportunity areas, RHI is unique its focus on increasing the supply of housing in opportunity areas regionwide. Its approach is consistent with lessons learned from Brookings’ work on Confronting Suburban Poverty in America: With CMAP as a strong quarterback, RHI has addressed the shortage of rental housing in the suburbs by working across jurisdictions, developing shared priorities, metrics and selection criteria, and by working with IHDA and other stakeholders to leverage greater private sector investment.

This recipe for success is now being deployed in communities beyond Chicago. Baltimore is preparing to advertise for its first round of developer applicants under the leadership of the Baltimore Metropolitan Council, with regionwide PHAs, the State Housing Finance Agency, and a regional housing counselor lined up as supportive partners. In St. Louis, the regional planning and housing finance organizations both attended the February conference where I met Stephen, signaling the potential for greater collaboration for both these entities and the PHAs.

Like many housing advocates and professionals, my colleagues and I at BRicK Partners derive a lot of satisfaction from supporting communities like Baltimore and St. Louis and individuals like Stephen and his peers with replicable best practices. Given today’s political realities, we don’t expect major changes in the federal formulas and statutes behind some of the regional inequities, but “work arounds” such as RHI can still scale up. Nationwide, just a small percentage of HCVs have been converted for such flexible supply-side solutions, but there is reason to be hopeful that this will change. The Regional Mobility Demonstration proposed in the 2017 budget as well as federal public housing voucher legislation passed by the House of Representatives earlier this year are signs that there is real momentum to advance regional strategies that increase access to opportunity for low income residents and families. 

      

       

       

       

Bringing together the five counties of Southeastern Pennsylvania, the nonprofit Metropolitan Caucus, a new regional consortium there, is promoting a joint regional application for ARRA’s competitive Energy Efficiency and Conservation Block Grant dollars. Its four-part proposal, which will add and refine partners and programs over time, draws on the collaboration of multiple regional institutions to establish and operate a loan fund for green building and retrofits; support clean energy technology deployment; assist local governments with energy efficiency plans; and measure the energy performance of public facilities.

The newly created Metropolitan Caucus of southeastern Pennsylvania is leading the bold new regional energy efficiency strategy targeting for the competitive Energy Efficiency and Conservation Block Grants (EECBG) in the American Recovery and Reinvestment Act (ARRA). Unprecedented for the region, the Metropolitan Caucus has brought together five area counties—Bucks, Chester, Delaware, Montgomery, and Philadelphia—to make the most of the stimulus opportunity by coordinating their plans, goals, and assets to achieve maximum regional benefit. Their proposed joint EECBG competitive application for roughly $35 million calls for financing construction and retrofits, supporting clean energy companies, measuring building energy performance, and assisting local governments in implementing various sustainability solutions. To carry out each of these activities, the caucus intends to engage in broad cross-sector collaboration to leverage the strengths and unique assets of regional educational institutions, key nonprofits, and planning agencies.

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The mayoral election in Baltimore has brought local economic development strategies to the forefront. In a city in which inequality—by income, by race, and between neighborhoods—has increased in the past five years, the candidates have made it clear that more action must be taken to close disparities and improve economic outcomes for all residents. In a podcast segment, I commend the much-needed focus on equity but argue that the mayoral candidates should not lose sight of another critical piece of the equity equation: economic growth. Citing lessons from my recent paper, I outline strategies that Baltimore’s presumptive leaders should pursue—as well as several they should abandon—to place the city’s residents on the path to a more prosperous, equitable future.

Listen to the full podcast segment here: 

       

Event Information

Antibacterial drug resistance is a global public health threat poised to worsen due to the combination of the inappropriate use of existing drugs and a marked decline in innovative antibacterial drug development. In order to tackle this problem, stakeholders must consider comprehensive strategies that address both drug development and stewardship.

On February 7, the Engelberg Center for Health Care Reform convened an expert workshop, “Modernizing Antibacterial Drug Development and Promoting Stewardship” to explore a two-pronged approach to combating antibacterial drug resistance that includes: 1) the development of pathogen-focused antibacterial drugs that target the most serious public health threats; and 2) stewardship efforts for all antibacterial products in order to preserve their utility. Participating stakeholders included experts from the drug development and health care industries, the clinical community, government, and academia. These stakeholders shared their insights on potential frameworks and evidentiary considerations for pathogen-focused drug development, and efforts underway to promote the appropriate use of commonly used antibacterial drugs in the ambulatory care setting.

Event Materials

• Antibiotic Development Slides
• 07 antibacterial expert workshop discussion guide
• 07 antibacterial expert workshop public agenda
• 07 antibacterial expert workshop meeting summary

       

Event Information

Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.

Event Materials

• Continuous Manufacturing Agenda
• CM Panelist Bio Sheet
• Participant list
• Continuous manufacturing discussion guide
• allslides_Continuousmanufacturingworkshop_101915
• meetingsummary_101915_continuousmanufacturing

       

       

       

       

       

       

Many American households do not save for retirement. Those that do save often contribute too little, invest poorly, or withdraw funds early. These patterns leave households, particularly low- and middle-income households, vulnerable to insufficient savings to finance adequate living standards during old age and retirement.

This research report proposes retirement saving reforms designed to help boost saving among low- and middle-income households. These 11 proposals are grouped under five themes: (1) making saving easier, (2) making saving more rewarding, (3) strengthening the market infrastructure for saving, (4) providing private information to savers, and (5) improving public education for saving.

Download the full report at aarp.org »

      

In this year’s State of the Union Address, President Obama announced a new retirement savings account for workers whose employers do not offer any form of pension or savings plan. He also promoted the Automatic IRA, a retirement savings plan that originated at the Retirement Security Project and has been in the Administration’s budget for several years.

Only about half of workers has access to a retirement savings plan at work. Millions of Americans lack the ability to save at work via payroll deductions. And while these individuals could in theory save on their own in an IRA, the best estimate is that only about one in twenty eligible to contribute to an IRA actually do so on a regular basis.

To help solve this problem, the President announced the creation of My Retirement Account, or “MyRA.” Similar to the R-Bond discussed in a recent AARP Public Policy Institute paper written by William Gale, David John and Spencer Smith, MyRA would allow individuals to save in a government bond account similar to the one offered as an option to federal employees through the Thrift Savings Plan. The details are unclear (there’s a WhiteHouse fact sheet here), but MyRA would allow new savers and those with small balances to accumulate retirement savings without either having to pay administrative charges or face market risk. Employers would not administer the plan or have any fiduciary responsibilities related to the accounts. Importantly, too, contributions come from employees, not employers. The plan is meant to build off of existing institutions—payroll deduction, Roth IRAs, the G-fund in federal employees’ thrift saving accounts. And it is meant to supplement, not substitute for, 401(k) and other company-based retirement plans. It accomplishes the latter by only allowing contributions up to the IRA limit, by limiting investment choice, and by having people with more than a set balance move into a regular account.

This approach is a boon to those who can only afford small contributions to retirement accounts. Private sector funds often require minimum contributions that are out of reach of low-income savers or assess high fees to offset their costs.

The key questions are whether employers will participate and whether automatic enrollment (that is, a regular contribution on behalf of all employees who do not opt out) would be allowed for MyRA accounts. Research suggests that automatic enrollment would greatly boost the number of employees who participate.

President Obama also promoted the Automatic IRA, but that would require congressional action, something that has not happened so far. Because the Automatic IRA would require employers with more than 10 employees to offer retirement accounts, it would likely dramatically increase the number of workers who save for retirement. It would also give employees a greater choice of investment options and serve as a permanent retirement savings plan, rather than a starter account like MyRA.

With Tuesday night’s mention of both proposals, the president made retirement security a priority. Both proposals would allow workers to build economic security through their own efforts and promote the kind of values and self-reliance that both sides of the political spectrum find attractive.

      

       

       

       

Event Information

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The financial sector has undergone major changes in response to the Great Recession and post-crisis regulatory reform, as a result of the Dodd-Frank Act and Basel III. These changes have created serious questions about the sector’s role in supporting economic growth and how it affects financial and overall economic stability.

On June 8, the Initiative on Business and Public Policy at Brookings explored the intersection of the financial system and economic growth with the goal of informing the public policy debate. The event featured a keynote address by Richard Berner, director of the Office of Financial Research and other participants with a wide range of views from a variety of backgrounds. Among other issues, the experts considered the changing landscape of the financial sector; growth-promoting allocation and investment decisions; credit availability for low- and moderate-income households; the ideal balance between growth and stability; and the impact of the 2014 midterm elections on regulatory reform.

 Follow the conversation at @BrookingsEcon or #Finance.

Video

• Keynote remarks by Richard Berner
• The financial sector: How has it changed?
• The view from the trenches
• The future of the U.S. financial sector

Audio

• Can the financial sector promote growth and stability?

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• Aaron Kleins presentation
• 20150608 BAER slides
• 20150608 MEHTA slides
• 20150608_financial_sector_stability_transcript