Happy Holidays from PPI

It’s been a surreal political year, but PPI has much to celebrate this holiday season. Throughout 2017, we expanded our productive capacity and the scope of our political and media outreach significantly. For example, PPI organized 150 meetings with prominent elected officials; visited 10 state capitals and 10 foreign capitals, published an influential book and more than 40 original research papers, and hosted nearly 30 private salon dinners on a variety of topical issues.
Best of all, we saw PPI’s research, analysis, and innovative ideas breaking through the political static and changing the way people think about some critical issues, including how to revive U.S. economic dynamism, spread innovation and jobs to people and places left behind by economic growth, and modernize the ways we prepare young people for work and citizenship.
Let me give you some highlights:
  • This fall, David Osborne’s new book, Reinventing America’s Schools, was published on the 25th anniversary of the nation’s first charter school in Minnesota. David, who heads PPI’s Reinventing America’s Schools project, documents the emergence of a new “21st Century” model for organizing and modernizing our public school system around the principles of school autonomy, accountability, choice, and diversity. David is just winding up a remarkable 20-city book tour that drew wide attention from education, political, and civic leaders, as well as the media. Because David is a great storyteller, as well as analyst, it’s a highly readable book that offers a cogent picture of a K-12 school system geared to the demands of the knowledge economy. It makes a great holiday gift!
  • Dr. Michael Mandel’s pioneering research on e-commerce and job creation also upended conventional wisdom and caught the attention of top economic commentators. Dr. Mandel, PPI’s chief economic strategist, found that online commerce has actually created more jobs in retail than it destroys, and that these new jobs (many in fulfillment centers in outlying areas) pay considerably better than traditional ones. His research buttresses the main premise of PPI’s progressive pro-growth agenda: that spreading digital innovation to the physical economy will create new jobs and businesses, raise labor productivity, and reduce inequality.
  • PPI challenged the dubious panacea of “free college” and proposed a progressive alternative – a robust system of post-secondary learning and credentials for the roughly 70 percent of young Americans who don’t get college degrees. PPI Senior Fellow Harry Holzer developed a creative menu of ways to create more “hybrid learning” opportunities combining work-based and classroom instruction. And PPI Senior Fellow Anne Kim highlighted the inequity of current government policies that subsidize college-bound youth (e.g., Pell Grants), but provide no help for people earning credentials certifying skills that employers value.
  • Building on last year’s opening of a PPI office in Brussels, we expanded our overseas work considerably in 2017. In January, I endeavored to explain the outcome of the U.S. election to shell-shocked audiences in London, Brussels, and Berlin. In April, we led our annual Congressional senior staff delegation to Paris, Brussels, and Berlin to engage European policymakers on the French presidential election and other U.S-E.U. issues, including international taxation, competition policy, and trade. PPI also took its message of data-driven innovation and growth to Australia, Brazil, Japan and a number of other countries.
Other 2017 highlights included a strategy retreat in February with two dozen top elected leaders to explore ideas for a new, radically pragmatic agenda for progressives; a Washington conference with our longtime friend Janet Napolitano (now President of the University of California system) on how to update and preserve NAFTA; public forums in Washington on pricing carbon, infrastructure, tax reform, and other pressing issues; creative policy reports on varied subjects; and a robust output of articles, op-eds, blogs, and social media activity.
I’m also happy to report many terrific additions to PPI in 2017. Rob Keast joined to manage our external relations and new policy development; Paul Bledsoe assumed a new role as Strategic Adviser as well as guiding our work on energy and climate policy; and Emily Langhorne joined as Education Policy Analyst. We will also be adding a fiscal project next year.
All this leaves us poised for a high-impact year in 2018. In this midterm-election year, our top priority will be crafting and building support for a new progressive platform — a radically pragmatic alternative to the political tribalism throttling America’s progress. That starts with new and better ideas for solving peoples’ problems that look forward, not backward, and that speak to their hopes and aspirations, not their anger and mistrust.
It’s a tall order, and we cannot succeed without your help and support. Thanks for all you have done over past years, and we look forward to working with you in 2018.
Happy holidays and New Year!

Connecticut’s Embarrassing Anti-Innovation Law

Innovation is the foundation of growth. As innovation spreads to the physical industries, the result is higher wages, lower costs, and a more dynamic economy, as we showed in our recent report, The Coming Productivity Boom.

But innovation in physical industries  has proceeded slower than we might have wanted, In part, that’s because promising technologies are being hindered at the state and local  level. Consider the humble eye refraction. Some companies are rolling out technologies that enable ordinary people to do eye refractions remotely, using computers or smartphones. Such a technology has the potential to greatly reduce the cost of updating and renewing contact lens prescriptions, while enabling people to check their eyes more often.

Unfortunately, in Connecticut, the state legislature is now considering a bill that would undercut the use of remote eye refractions. The bill says, in part:

No provider shall issue an initial prescription to or renew an initial prescription for a patient without having performed an in-person evaluation and an eye examination of the patient.

In other words, everyone has to make an expensive and time-consuming in-person trip to an eye doctor to get a prescription renewal for contact lens, even if the remote refraction says no change. This requirement could be especially costly in Connecticut, where optometrists make $192,870 per year on average, the highest in the country, according to the Bureau of Labor Statistics.* Indeed, Connecticut is the only state where optometrists make more than family and general practitioners, based on BLS data.

Remote refraction can and should never replace in-person visits to optometrists and ophthalmologists. But in a world where health care costs are increasingly squeezed, it seems silly and downright embarrassing for a forward-looking state like Connecticut to inhibit a technology that could make people better off at a lower cost.

*These figures are based on the May 2016 Occupational Employment Statistics from the BLS. See this page for a list of top-paying states for optometrists. This data does not cover self-employed workers.

Pharmaceuticals Accounted for Only 11% of the Rise in Health Care Costs in 2016

For the past several years, PPI has analyzed the key drivers of health care costs. This year, as the Senate considers repealing the ACA, it’s especially important to correctly attribute the causes of rising health care costs.

Our main result is that rising labor compensation for health care workers accounted for 44% of the increase in personal health care spending in 2016. This preliminary analysis is based on compensation data from the Bureau of Economic Analysis, wage and employment data from the Bureau of Labor Statistics, and projected health care expenditures from the Centers for Medicare and Medicaid Services.  In dollars, estimated labor compensation for health care workers rose by $61,5 billion in 2016, compared to a total increase of $139.1 billion in personal health care spending. (We will update these estimates after the BEA publishes its annual revision in July).

The rise in labor compensation was driven by a 2.5% increase in private and public health care employment in 2016, the biggest increase since 2008, and far in excess of population growth.

What about pharmaceutical costs? According to the latest report from the QuintilesIMS Institute,  spending on ‘medicines’ (pharmaceuticals) rose by $14.8 billion in 2016, net of estimated rebates and other price concessions by manufacturers. Consequently, net spending on pharmaceuticals only accounted for 11% of the increase in personal health care spending in 2016.

All told, the increase in labor compensation for health care workers is 4x the increase in net spending on pharmaceuticals.  To put it another way, any savings on drugs will be very quickly eaten up by increased labor costs. As a result, the only sustainable way to control health care costs is to restrain the growth of health care employment.

 

 

 

 

 

Bledsoe for RCP: The Shared Illusions of Brexit and Obamacare Repeal

“Have your cake and eat it.”  With these six aggressively monosyllabic words, the redoubtable Boris Johnson came clean, almost despite himself, about the contradictions of Brexit, and perhaps those of today’s right-of-center populism altogether.  In time, the phrase may be seen as the defining utterance of the post-truth era in trans-Atlantic politics.

The Washington corollary was minted by an aide to Republican Senate Leader Mitch McConnell regarding Obamacare – “repeal and replace.”  Less elegant, perhaps, but the inherent hubris and contradictions are much the same:  After throwing them off the system, we can then provide more than 20 million Americans health insurance, without patient costs, government expenditure or regulation, since our ideology forbids considering those policies.

Of course, in real life, and even eventually in politics, one must choose to either eat cake or have it.  Britain currently seems to have a slightly stale piece of cake, and a largely hungry populace.  Their American cousins, meanwhile, have a simple homespun saying: “You can’t replace something with nothing.” Yet, for the time being, that is precisely what congressional Republicans plan to do regarding Obamacare.

Continue reading at Real Clear Politics. 

Medicaid patients need options in opioid fight

In the sad geography of America’s opioid-overdose crisis, Ohio is at the center of the map. In 2015, 2,700 of its people died from prescription and illicit opioids, a number far higher than any other state and one that shot up by 28 percent in one year.

In response, Gov. John Kasich signed a bill this month to expand access to the treatment drug naloxone, therapy, and social supports.

Why more than 50,000 Americans died from drug overdoses in 2015, and why Ohio — or Massachusetts, for that matter — has opioid death rates 12 times that of California or Texas are critical questions. But just as critical is preventing and treating the nation’s 2.6 million opioid addicts and other users, reducing the availability of illicit drugs like heroin, reversing the prescription frenzy that now results in about one opioid prescription per year for every adult American, and fighting the lobbying behemoth of pharmaceutical companies making prescription painkillers like OxyContin and fentanyl.

Continue reading at the Toledo Blade

Fighting Poverty with HOPE

Economists often apply the term “opportunity costs” to high and middle-income people, meaning that the time they spend on one task is time not available to perform other, potentially more valuable tasks. But social scientists rarely apply the concept to low-income people, acting as if their time is essentially worthless. Sort of like the spouse who doesn’t count your food shopping, cooking, cleaning, child-rearing, accounting for family finances, shuttling family member to appointments, taking care of your sick parents, etc., as work.

Yet, in addition to lacking money, low-income Americans frequently lack time. Just as many personal relationships collapse when people don’t have “quality time” with each other, a lack of time works mightily against the efforts of lowincome people to have constructive relationships with their families and with the broader society.

 


 

The Value of the Medicare Part D Program for its Beneficiaries and the Medicare System

In the United States and other advanced countries, governments and individuals regularly lament the high and ever-rising costs of healthcare; and the ongoing aging of their populations virtually ensures that these costs will continue to increase — perhaps at substantial rates.

Many analysts identify the development and broad use of new healthcare technologies as primary sources of these cost increases; and, in the public debate over rising costs, new prescription drugs are often singled out as critical cost drivers. This study examines the cost-benefit calculus for prescription drugs in the context of Medicare and overall healthcare in the United States.

 

Medicare_Part_D

 

Rising Labor Costs Accounted for 47 percent of Increased Personal Health Care Spending in 2015

According to PPI estimates, rising labor costs accounted for almost $65 billion in added health care costs in 2015, or 47 percent of the total increase in personal health care spending (as reported by the latest projections from the actuaries at the Centers for Medicare and Medicaid). By contrast, IMS reports that net spending on prescription drugs rose by only $24 billion in 2015, or 18 percent of the rise in personal health care spending.

driving

This result, which updates our previously published data for 2014, fights the prevailing narrative that healthcare spending is primarily driven by rising drug prices.. Instead, the big increase in labor compensation in 2015 is mainly being impelled by the rapid growth of health care employment.  The number of workers in the nation’s hospitals, physician offices, and nursing homes increased by 429,000 in 2015, compared to an annual average of 226,000 for the previous 5 years.

Unfortunately, this trend of rapidly rising healthcare employment driving overall spending appears to have accelerated in 2016. Healthcare employment in the 12 months ending July 2016 was more than 500,000 above its year earlier level, suggesting that healthcare labor costs will surge even more in 2016.

Meanwhile data from the BEA seem to show the pace of pharmaceutical spending slowing in 2016. Consumer spending on prescription drugs in August 2016 was 4.3% over a year earlier, less than half as fast as in 2015. There’s no guarantee that this slower pace will continue for the rest of 2016, but so far it’s a good sign.

healthemp

 

 

 

 

 

 

 

The Productivity Growth Slump and The Case of the (Missing) Contact Lens

Productivity growth in the United States continues to slump.  The latest numbers from the BLS show that multifactor productivity growth was only a tiny 0.2% in 2015.

In particular, gross medical productivity of the US healthcare system fell by 1.2% in 2015, according to PPI’s calculations.* That’s after two years of ticking up slightly.

Falling gross medical productivity implies that healthcare employment is increasing faster than the population, even after adjusting for the changing age mix. That’s not fiscally or economically sustainable over the long run, because it means that healthcare is absorbing more and more of the workforce, and leaving less for other productive activities.

Is this negative productivity trend going to continue? The good news is that innovation in pharma, medical devices, and apps has the potential for reducing the amount of excess labor costs in the healthcare system (see, for example, “The Folly of Targeting Big Pharma,” WSJ, December 10, 2015).

The bad news is that some groups of medical providers are looking to retain or even extend inefficient and costly practices by fighting back against new technologies and online delivery systems. For example, the trade group for optometrists recently filed what they called an “expansive” FDA complaint against a vision-texting app. This app would cut costs and save labor by letting people test their vision at home and send the data to a licensed ophthalmologist for a prescription.  Similarly, the optometrists also support a new bill in the Senate that would make it harder and more expensive for consumers to use valid prescriptions to buy their contact lens online, even at a time when more and more shopping is done via the Internet.**

The U.S. needs to embrace productivity growth in the healthcare sector if overall productivity and living standards are to rise for everyone. Hopefully 2015 will turn out to be a blip rather than a trend.

*Gross medical productivity is defined to be the age-adjusted population, divided by the number of workers in the broad healthcare sector, and benchmarked to 2009=100. The population is adjusted for the relative cost of health care at different ages. The broad healthcare sector includes private and public hospitals, ambulatory care facilities, nursing homes, pharma and medical device manufacturers, biotech companies, and health insurers.

Gross medical productivity is an easy-to-calculate measure of how well the health care system is using labor resources to treat the potential patient population. Labor is important because it accounts for a large share of the cost of health care. We use age-adjusted population as the numerator because any of us—no matter how healthy—can become an involuntary consumer of healthcare at any moment.

** PPI first wrote about this issue in 2001, in a policy paper entitled “The Revenge of the Disintermediated: How the Middleman is Fighting E-Commerce and Hurting the Consumer.”

WSJ: The Folly of Targeting Big Pharma

An unfortunate refrain among Democratic presidential hopefuls is that rapacious pharmaceutical and biotech companies are driving up the cost of essential medications, bankrupting the health-care system, and depriving sick Americans of treatment. Hillary Clinton has honed her message to a nice sound bite: Drug companies that charge excessively high prices “are making a fortune off of people’s misfortune.”

A report released Dec. 2 by the Centers for Medicare and Medicaid Services shows a 12.2% increase in spending on prescription drugs in 2014 after an average 2% increase for the previous six years. As the CMS report clearly states, “the rapid growth in 2014 was due to increased spending for new medications (particularly for specialty drugs such as hepatitis C).” Yet the increase, combined with reports of drug companies attempting to jack up prices on existing drugs, has some calling for full-blown government price controls.

The way we pay for innovative drugs can certainly be improved. But the anger directed at the pharmaceutical and biotech industries overall is misdirected. The single biggest driving force for increased health-care spending in the U.S. is the rising cost of labor, not drugs. According to data from the Bureau of Economic Analysis and estimates by the Progressive Policy Institute, total labor compensation at hospitals, doctors’ offices, ambulatory care facilities and nursing homes has risen by roughly $270 billion since 2007, including the amount paid to doctors and dentists who own their own practices.

Continue reading at the Wall Street Journal.

The Sacramento Bee: Science, not politics, should drive California regs on BPA

As the presidential campaign season gets underway, it reminds us how much we loath the politics of fear mongering. Half-truths and half-baked policy proposals have become staples of modern campaigns. You betcha!

Until recently, there was a difference between campaigning and governing. Governments are supposed to base their decisions on hard facts and real science. In today’s hyperpoliticized culture, though, the regulatory process can also get hijacked by special-interest groups armed with “narratives” that are simple, emotional and deeply misleading.

California, which is widely known for its progressive politics, should shun governing by scare tactics in defining today’s progressive vision for regulation. As Vice President Al Gore did with the National Partnership for Reinventing Government, progressives should grab the pragmatic view that agencies get smart on an issue, develop targeted regulations and use their authority to solve real problems.

California voters back this vision. They recently voted against requiring warnings on genetically modified foods as unwise regulation. The Obama administration has since concluded the fears of GM products are unwarranted. In April, the U.S. trade representative chastised European regulators for allowing “opt-outs” of U.S. imports of GM products as “ignore(ing) science-based safety and environmental determinations.”

Chalk one up for California’s progressive governing.

On the other side of the ledger is California’s decision last month to add bisphenol A, or BPA, to the list of toxicants under Proposition 65. BPA has been used to coat the inside of bottles and cans since the 1960s to keep harmful germs from growing inside them.

Continue reading at The Sacramento Bee.

Read more here: https://www.sacbee.com/opinion/op-ed/article24896143.html#storylink=cpy
Read more here: https://www.sacbee.com/opinion/op-ed/article24896143.html#storylink=cpy

Carew for Republic 3.0: The Case for a Data-Driven FDA

The Food and Drug Administration (FDA) is fast finding itself at the center of the debate over healthcare regulation in the 21st century. At issue: to embrace the power of data-driven innovation, or to stand by the current regulatory paradigm. Fortunately, two major Congressional initiatives may be the push the FDA needs to see the data-driven economy as an opportunity instead of a risk.

Current rulemaking at the FDA follows a rubric laid out in 20th century legislation: safety and efficacy above all else. Medications and devices must be proven to be at least as good as what’s already available, through long and extensive clinical trials. All publicly available information about medications and devices must be deemed truthful and non-misleading, essentially sticking to only what’s “on-label.” The underlying assumption is that all drug and medical device companies are driven by profits, even if at the expense of public health.

The FDA’s current approach imposes strict requirements on drug and device companies that few other industries are subject to. Even the seemingly simple goal of sharing information is highly complicated under the current system. As PPI has documented, drug and device companies face a severely restricted ability to communicate information to the medical community and to consumers. So onerous are the requirements that many drug and device companies have more incentive to block the flow of information than to create it. Patients are hurt most because medical providers lack access to the best resources to treat them.

Such an outmoded approach to rulemaking will likely dampen future innovation and investment in healthcare. We live in a “sharing economy,” defined by the rise of the Internet, social media, and instant communication. Our unprecedented connectedness has facilitated an explosion of medical apps and real world observational data. Imagine how harnessing and sharing this information could help the 117 million Americans living with a chronic disease, or 20 million Americans with cancer, many of whom rely on unapproved uses of approved drugs for treatment.

Yet such potentially valuable information could not be shared under current rules. The FDA requires any sharing of information on unapproved uses of approved drugs be based on “adequate and well-controlled” clinical investigations, documented in peer-reviewed journals. Instead of embracing the power of data, the FDA seems to be scared of it.

Fortunately, two recent initiatives in Congress are addressing this critical need for rethinking the FDA’s approach to regulation. They are both ongoing efforts, driven by the opportunity to modernize our approach to healthcare rulemaking. Notably, both efforts explicitly address the outmoded approach to communications as a core part of 21st century healthcare regulation reform.

The House initiative, dubbed 21st Century Cures, has spent the last year collecting public comments and conducting analysis on how to use data-driven innovation to redesign healthcare. The most recent white paper notes, “as innovative companies know more about their products than anyone, precluding them from responsibly communicating about new scientific and medical developments does not promote the public health.”

In the Senate, Innovation for Healthier Americans similarly seeks to arm the FDA with tools to modernize healthcare regulation. It argues that restrictions on how drug and device companies can communicate could actually harm public health. The report notes that “in today’s online world[,] where doctors can look on the internet and find studies, it may be a disadvantage not to be able to discuss this information with the product developers who know the most about the project.”

The House and Senate efforts to modernize healthcare regulation give the FDA a rare opportunity to shine. By rethinking its approach to rulemaking in the 21st Century, the agency could define the future of U.S. healthcare design and delivery.

Instead of being viewed as bureaucratic, inefficient, opaque, and over-priced, the U.S. healthcare system could be innovative and dynamic. Customized nano-medicine, treatment delivered remotely, and apps that monitor chronic disease could be the envy of other healthcare systems.

Such a large-scale task may seem daunting for one regulatory agency, but the FDA could start small – say, with communications regulation. By allowing drug and medical device companies to better communicate with the medical community and consumers, a data-driven healthcare ecosystem could sprout and flourish. Each part of the diagnosis and treatment chain could work together, employing cost-saving techniques that improve patient outcomes.

The FDA opportunity should not be taken for granted. With the aid of Congress, it is possible for one agency to set the new gold standard for healthcare regulation, ensuring information is truthful and non-misleading, but also embracing the power of data to improve public well-being.

This is cross-posted from Republic 3.0.

Why the Healthcare Job Boom May Be a Bubble, and Why Progressives Should Care

Our recent report on tech employment, authored by myself and Diana Carew,  calculated that women have been getting three times as many healthcare-related bachelors degrees as men. A NYT article from February 2015 lauded women for taking advantage of the stable, middle class jobs in healthcare, observing that

As the job market has shifted, women, in general, have more skillfully negotiated the twists and turns of the new economy, rushing to secure jobs in health care and other industries that demand more education and training. Men, by contrast, have been less successful at keeping up.

And indeed, the number of healthcare jobs have soared, even during the recession, propelled by government spending and the aging of the population. In fact, college administrators, students, and policymakers have encouraged young Americans and mid-career switchers to go into healthcare.

But the healthcare employment boom may actually represent a bubble. College students and administrators may be overestimating the safety and security of healthcare careers, especially in an era where the healthcare sector is under increasing pressure to control costs. And if the bubble bursts, women may bear the brunt. Consider the following chart.

healthprod1
The first bar of the chart shows that total population grew by 3.1% between 2010 and 2014. The second bar adjusts population to account for higher spending on the elderly, by effectively tripling the contribution of 65-and-over Americans. So demographics by itself would argue that healthcare spending and employment would rise by 5.4% between 2010 and 2014.

In fact, healthcare employment rose by 6.6% over the same stretch. The fact that healthcare employment is outpacing adjusted population is the most tangible manifestation of healthcare costs being out of control.

We calculated what we call “gross medical productivity”–adjusted population divided by the number of healthcare workers. We’d like to see gross medical productivity rise, which would mean that fewer healthcare workers are needed per potential patient, adjusted for demographics. In fact, the exact opposite is happening–even after we adjust for demographics, more healthcare workers are needed for each potential patient in the population.

So the healthcare employment boom is being fueled by falling gross medical productivity, or, conversely, rising costs. As we note in the tech employment paper:

Containing healthcare costs therefore means incorporating productivity enhancing—or cost- cutting—technology into the sector…That means that to increase productivity and reduce costs long-term, the rate of increase of healthcare employment needs to slow.

Note that we are not saying that healthcare employment will fall, as manufacturing employment did. Healthcare jobs are still relatively protected from foreign competition, and people value health as much as anything else. Yet given the number of young people and mid-career switchers going into healthcare, we could easily have a situation where the mere slowdown in healthcare employment growth by 1 percentage point could dramatically shift the balance of supply and demand in the field.

Given the strong possibility of such a change, we suggest that progressives should strongly support a diversification of college degrees out of healthcare and into other growing areas such as tech. This is especially important for women, who according to our calculations got more than 20 healthcare-related bachelors degrees for every tech-related degree in 2013.

 

 

 

 

 

 

Why Obamacare is the heart of the new pro-growth, pro-middle class, pro-entrepreneur Democratic Party (sorry, Senator Schumer)

Senator Schumer has made a plausible argument for why Obamacare was a political mistake.  I disagree. Democratic politicians have mainly defended Obamacare on the grounds of access, fairness and cost containment. But in the process, Democrats have missed an opportunity to show how Obamacare is a platform for entrepreneurial growth. Framed correctly, Obamacare could turn out to be the heart of the new pro-growth,  pro-middle class, pro-production Democratic Party.

Consider this. When I left BusinessWeek in 2009, I started my own company, Visible Economy,  making news and education videos (the website and the business, alas, are no longer active).  As a budding not-so-young entrepreneur, the only reason I had that choice was because I could carry over healthcare coverage from my previous employer. If I had no health insurance, I couldn’t have started the business.

Obamacare allows almost anyone who wants to start a business to do so, without fear of being excluded from healthcare coverage because of age or pre-existing conditions. This is a big deal, for two reasons. First, because any sane middle-class person will think twice about starting a new business if they can’t get healthcare coverage (“entrepreneur lock“).

Second, Democrats who embrace a pro-growth, pro-innovation message can go to voters with Obamacare as an opening example of what the party is willing to do for the middle class.  The pro-growth message will increasingly resonate over time, especially if the party backs up Obamacare with additional pro-growth reforms, such as smart regulation and less reliance on onerous and regressive fees and fines on the local level (that turned out to be a big part of the issue in Ferguson).

From a political perspective,  Obamacare can unite the Democratic party. PPI has long strongly supported ACA-like universal healthcare coverage. That goal resonates with the Elizabeth Warren wing of the Democratic party as well. Obamacare brings poor working families into the healthcare system, and at least up to now, appears to be slowing the rate of health care cost increases.

It was inevitable that whichever party initiated healthcare reform was going to take political damage–that’s why it took so long.  Now Democrats need to use Obamacare as a key building block of their pro-growth message.

 

 

 

 

 

 

 

 

Hacking the Regulatory State: The FDA

I am speaking Thursday at a Cato conference on The Future of U.S. Economic Growth, with a politically diverse group of speakers including Martin Baily, Robert Gordon, Brad DeLong and Erik Brynjolfsson. My panel is entitled”What is to be done?,” and focuses on feasible policy solutions.

In preparation for the conference, I put together an essay on “Hacking the Regulatory State.” Part of the essay covers the need for a Regulatory Improvement Commission, but I also laid out some ways that the FDA can be reformed to speed up economic growth. Here’s an excerpt from the essay:

2. Approval Criteria at the FDA

The FDA is one of the fastest growing agencies in the federal government. In 2000, the FDA employed 12 workers for every 1,000 in the pharmaceutical, biotech, and medical equipment industries.  Now the FDA employs 18 workers for every 1000 private-sector pharmaceutical, biotech, and medtech workers.

Not surprisingly, the intensity of FDA regulation has also increased by 40 percent since 2000, according to a recent paper from the Progressive Policy Institute (Carew, 2014). That’s based on a new measure of regulatory intensity that applies a semantic analysis of written rules, looking for such restrictive words as “shall” and “must” (Al-Ubaydli and McLaughlin, 2014).

The same period has also been notable for an extraordinary amount of public and private spending on biosciences R&D. In 2012, for example, U.S. industry, government, and academic institutions spent roughly $100 billion on biosciences-related research and development, second only to the roughly $125 billion invested in computer and information sciences-related R&D. In recent years biosciences R&D has averaged somewhere between one-third and one-quarter of total civilian R&D.

This R&D spending has propelled tremendous scientific advances over this stretch. Yet so far, too few of these scientific advances have been translated into usable innovation. This problem is well-accepted. NIH set up a new National Center for Advancing Translational Science in fiscal year 2012, specifically to “develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients.”

I will argue here that accelerating commercial innovation in biosciences requires “recoding” the criteria by which the FDA approves new drugs and devices. In particular, the sole focus on “safety and efficacy” has the effect of almost guaranteeing that potential disruptive innovations are not approved. What’s more, the pharmaceutical and device companies have a deep understanding of the FDA’s approval process, and therefore they do not pursue such disruptive innovations. Similarly, venture capitalists shy away from funding innovations that are not approvable.

Here I’m using the disruptive innovation in the classic Clayton Christensen sense — a product or service that starts out with somewhat worse performance than what’s on the market right now, but much better economic or other characteristics. So when mobile phones originally were being widely sold, the quality of calls was lower than using wired handsets. Similarly, the early personal computers were far less powerful than mainframes or minis.

The problem is that the FDA interprets the “safety and efficacy” standard as meaning at least as safe and clinically efficacious as anything on the market currently. That immediately rules out an innovation that is safe, much cheaper, but not as efficacious as best medical practice. So if the FDA had been in charge of the phone or computer markets at the time, early mobile phones and personal computers would have not been approved for sale because they provided inferior quality to existing products.

As a result, the FDA approval criteria systematically screen out disruptive innovations. What’s more, the pharmaceutical and device companies, and even the venture capitalist supporting start-ups, are all too aware of the FDA’s decision-making process,  and are therefore unwilling to fund potential disruptive innovations.

What’s the solution? First, don’t weaken the safety requirement at all. The FDA is a key guardian against harmful products.

Second, separate the efficacy requirement into two parts — clinical efficacy, and economic efficacy. Allow innovating companies to present evidence that their potential new product reduces the amount of labor and other resources needed by the healthcare system, as compared to existing products or treatments. A new product needs to show both clinical efficacy and economic efficacy, but needs to be superior to existing products on just one of those measures.

Such a broadening of the FDA approval criteria won’t be easy to put into place, but could have enormous impacts on the incentives for research and development. If we want medical innovation and lower costs, we need to change the rules of the game.

 

 

 

 

Press Release: PPI Releases Policy Memo Revealing FDA Regulations Struggling to Keep Up With the Digital Age

WASHINGTON—The amount of regulation on the pharmaceutical industry has increased 40 percent since 2000, according to a policy memo released today by the Progressive Policy Institute (PPI). Moreover, some new draft regulations proposed by the Food and Drug Administration (FDA) this year fail to embrace data-driven innovation.

In FDA Regulation in the Data-Driven Economy, PPI Economist Diana Carew details new regulations proposed by the FDA designed for a slower, information-poor age. The memo concludes with policy recommendations for how the FDA can improve outcomes while still protecting consumers in a data-driven economy.

“In a data-driven economy, regulators should encourage greater information sharing, instead of pre-emptively regulating information in a way that controls and ultimately restricts it,” Carew writes. “Regulators should take the role of watchful guardians over data and information flows, taking action when there is evidence of harm or injury.”

“We hope that regulators within the FDA and across other regulatory agencies will be able to use this example as a guide for approaching future regulatory questions surrounding data. Embracing the data-driven economy is the best way to promote future prosperity and well-being for all Americans.”

The memo focuses on one draft FDA guidance in particular, issued in February 2014, entitled “Guidance 
for Industry: Distributing Scientific and
 Medical Publications on Unapproved New Uses— Recommended Practices,” which lays out a lengthy list of rules and restrictions for how drug and medical device manufacturers are allowed to communicate with healthcare professionals and “healthcare entities,” such as hospitals, on unapproved new uses. It discusses the draft guidance and explains why it is not adequate for the digital age. Finally, recommendations for the draft guidance are provided, and the memo concludes with an expansion of the discussion to how this case study can serve as an example for regulators struggling with rulemaking in this time of unprecedented economic transformation.

PPI has undertaken extensive research on regulation in the 21st century, aimed at guiding regulators and policymakers through this transition. Our work strives to strike the right balance between protecting consumers and encouraging innovation in an interconnected world.

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