(Vaccine) Trial by Fire

Here’s what you need to know…

Bringing any new drug treatment to market is an arduous process with the potential for significant public and regulatory scrutiny even in normal times. Now, as pharmaceutical manufacturers prepare to bring hundreds of millions of doses of coronavirus vaccine to market, the stakes are anything but normal. As drug manufacturers tackle the complex science of creating a safe and effective vaccine at warp speed, public scrutiny will be even more aggressive.

In the current age of organized activism and lightning fast (mis)information sharing, no good deed goes without deep and exhaustive scrutiny from a wide range of policymakers, news outlets, competing advocates, and other stakeholders. This new reality means drug firms will need to lean on the expertise of their public affairs professionals to skillfully navigate the likely political and reputational risks as they seek to educate policymakers and the public about the benefits and reliability of their COVID-19 vaccines and their responsible and fair business practices.

The challenge of navigating such public scrutiny has never been more daunting, and if anything, is a sign of what’s to come for future public health challenges. To be successful, they will need to anticipate and prepare for six important questions:

Who gets the vaccine and in what order?

As global leaders prepare to embark on the “largest immunization campaign the world has ever seen,” questions remain about who should be eligible to receive early COVID-19 vaccine doses that will be in limited supply for some time. While pharmaceutical companies will work hard to ensure that billions of regimens are available as quickly as possible, the reality is it could take many months before those can be manufactured and distributed. That expected reality has patient advocates and political leaders debating how governments should prioritize the administration of the vaccination in the short term. Some argue that those in high-risk groups or those with significant co-morbidities should be at the top of the list, while others insist that health care workers and essential employees should go first. Others say that racial and ethnic groups that appear to be more susceptible to the virus, such as African Americans and Native Americans, should be top priority. This debate has global dimensions too, with concerns that first world nations with the ability to develop and pay for its administration will hoard the vaccine while it’s still in short supply, making a country’s ability to pay the chief determinant in whether or not its people are protected. No matter which groups are chosen to receive the first round of vaccinations, there will be those in other groups who wanted it but could not get it, leaving governments, health care organizations, and manufacturers facing an inevitable public backlash for which they must prepare.

Even if there’s a vaccination available, who will take it?

Amid the clamor to be first for the vaccine is another reality that many will be resist being among the first to try it in an uncontrolled setting. In fact, Gallup reported this week that one in three Americans would not receive a COVID-19 vaccination, while another survey showed as few as 50 percent of Americans are prepared to receive it. These individuals aren’t all traditional anti-vaxxers who refuse to vaccinate their children or receive a flu shot, but rather, are simply skeptical of a new vaccine’s efficacy and safety or skeptical of public health directives post-lockdown. Their hesitation is likely to fuel a cycle of public debate similar to that over masks, where the more the media and policymakers demand lockstep compliance, the more some citizens will feel that their concerns, legitimate and otherwise, are being disregarded. Such a debate will increase existing divisions and rancor while undermining needed public health outcomes, particularly if government bodies at various levels attempt to compel people to take the vaccine. For public affairs professionals in the life sciences community, the potentially Sisyphean task will be to ensure science and health facts are not lost amid the debate, particularly if and when reports, whether they are truth or myth, emerge to suggest the vaccine is ineffective or unsafe.

How will leaders address concerns of racial disparities in access and outcomes?

In recent months, the nation’s and, indeed, the world’s attention has turned to the subject of systemic inequality. While the discussion has largely focused on police practices and economic disparities, some say that coronavirus clinical trials do not accurately reflect the full diversity of the population, leaving researchers with a poor study population that may not demonstrate how the vaccine will perform with wide use. Still others fear that America lacks a plan on “how to reach racial and ethnic groups that have not only been devastated by the virus but are also often skeptical about government outreach in their communities,” according to Politico. Every aspect of the vaccine’s distribution, administration, and effects will happen in the context of this heightened scrutiny and social unrest regarding racial disparities. Meanwhile, public health officials and public affairs professionals will have to convince groups already disproportionately harmed by the coronavirus that efforts to distribute a vaccine in their communities are meant to help, not hurt, them.

Can the supply chain meet the demand fast enough?

Securing the supply chain is a crucial step to distributing the forthcoming COVID-19 vaccine. This task will be tough, as coronavirus has already exposed cracks in the worldwide supply chain for pharmaceuticals and medical supplies necessary to create and administer vaccines. Moreover, recent reports about limited quantities of crucial component parts, like hard-to-make vials, make it harder for health care professionals to actually administer the vaccination. Meanwhile, media and Congressional scrutiny on the Trump Administration’s decision to give substantial loan to Kodak after the photography company dedicated a record amount of money to lobbying the Administration for the aid has undermined plans to have the company help fill this supply gap and could dissuade other potential manufacturers from offering aid. Once companies begin sending a COVID-19 vaccine around the globe,  scientists are worried about supply chain viability issues such as counterfeiting and maintaining the necessary conditions to keep the vaccine cold enough for future use. For those representing the life sciences industry, they must be ready for new levels of scrutiny regarding their business practices, assuring the public and policymakers that they are behaving responsibly and competently, even in the midst of the chaos of crisis response. Renewed scrutiny could last long after coronavirus is under control, potentially establishing a new precedent in the oversight and regulation of the pharmaceutical industry.

What ownership does the public have?

For years leading up to the coronavirus pandemic, some advocates have argued that because a lot of basic scientific research is publicly funded via government grants and public universities, the public should have at least partial ownership in scientific discoveries made on their dime, whether the ownership takes the form of patents, data, or the product itself. With governments across the globe making multibillion dollar investments in pharmaceutical companies’ pursuit of COVID-19 vaccinations, some advocates say taxpayers should have ownership or rights to these treatments once they hit the market, an expansive and possible precedent-setting argument heard from activists who have long argued that in pursuit of universal health care, pharmaceuticals should be classified as a global public good. Because of this governmental investment, many argue that it should be totally free to the public, with some suggesting it be free for the entire global community. Pharmaceutical companies are trying to balance protecting their intellectual property with commitments and partnerships to make their product readily available when doses are urgently needed. In the long term, however, innovative life-saving treatments require intellectual property protections if there is going to be an incentive to develop and manufacturer them. Industry representatives will have to continue their efforts to make clear why these protections matter even as their firms contribute institutional knowledge, administrative costs, and corporate investment towards tackling the world’s greatest health care challenge in a century.

Has the immense focus on COVID-19 undermined efforts to develop and distribute treatments for other ailments?

Even as the world has seen nearly 21 million cases of coronavirus and 750,000 deaths associated with it, people all over the world are still dying of more predictable causes – around 150,000 of them each day. Heart disease, Alzheimer’s, diabetes, cancer, autoimmune diseases, and tuberculosis are still some of the most common causes of death, and among those living in low income countries, communicable diseases are 7 out of the 10 most likely ways people die. The life sciences community provides hope for cures and treatments that can extend, improve, and save lives. Leading up to coronavirus, great strides had been made to address a variety of illnesses and disease. Much of this research, including hundreds of vital clinical trials regarding other health challenges, has been stalled or canceled entirely as scientific efforts are directed to solve the immediate crisis of coronavirus. With economic stagnation and university closures to prevent COVID-19 transmission, labs are now empty, too. In the U.S. alone, important life science research on tumors, strokes, anemia, and cancer has come to a halt. As coronavirus becomes better managed, the illnesses and deaths of those not infected by COVID-19 will return to focus, and fairly or unfairly, so, too, will questions about the reversal of medical progress during this critical time.

We know a lot more about coronavirus than we did when it began. Care has improved, and a vaccine will soon be available. For those in the life sciences industry, this is unchartered territory – and for more than just the scientists racing to develop safe and effective vaccines. For public affairs professionals, the coronavirus crisis presents new challenges in policymaking and public relations, and they must be prepared to answer the tough questions about creating and distributing this desperately sought-after vaccine. Their ability to shape the knowledge and opinions of world leaders and the global population will be indispensable in the fight to eradicate this deadly disease and many others.

TL;DR: The Chain Drain: Rethinking Pharmaceuticals After COVID

Here’s What You Need To Know …

As the dust begins to settle from the coronavirus pandemic, the impact on the pharmaceutical industry is becoming clearer. Whether or not American drug manufacturers are ready, policymakers are scrutinizing the industry’s global supply chain and considering what steps to take to derisk it before another pandemic or other disruption hits. This scrutiny on supply chain and related trade issues had been mounting for some time before the pandemic, driven by the broader shift in public sentiment surrounding the benefits of free trade and globalization in the face of U.S. job losses, particularly in the manufacturing sector, that some attribute to unfair trade agreements.

Now policymakers in Congress and the Administration are advancing measures they hope will spur greater pharmaceutical manufacturing in America, protecting our national interests and returning high wage jobs to America. Indeed, some of these policymakers have been sounding the alarm for years about the economic and national security risks associated with keeping critical parts of our strategic industries, including the biomedical sector, overseas. Now the convergence of events and public sentiments has given them an unprecedented opportunity to advance their desired solutions.

Caught in the middle are pharmaceutical companies that must navigate these policy demands that could require enormous investments in new infrastructure amid a shake-up of the international supply chain. Meanwhile, other countries are watching, and their response to America’s policy direction could have its own implications for drug manufacturing and development. To understand how we got here, what policy shifts are underway, and how those shifts could impact the industry, here’s what you need to know.

How Did We Get Here?

Blame Trump And China: Mounting public concerns about free trade and global supply chains were heightened by President Donald Trump’s 2016 campaign, which focused in large part on holding China accountable for its trade practices. His aggressive posture on China, coupled with a slew of events in the past several years that raised awareness of China’s human rights practices, has sent American public opinion about the nation plummeting. Today, a record 66 percent of Americans hold unfavorable views of China, an astonishing 40-point margin reflecting its worst reputation in recent history due in part to the country’s widespread failures in responding to the coronavirus and its refusal to be honest about the virus’s severity.

The New Bipartisan Consensus: Labor unions and progressive voices within the Democratic Party have fought against free trade for decades. They argued that overseas operations eliminated domestic manufacturing jobs that were the bedrock of the American economy. Republicans long resisted these protectionist pleas, insisting that unfettered free markets drove down the cost of goods, making them more affordable to Americans while bringing about economic growth that would buoy the American workforce.

Now, with too many factory towns still empty and growing public sentiment that globalization destroyed higher paying American jobs, some prominent free market-oriented Republicans have shifted their approach to addressing America’s wealth inequality. This new approach connects that gap with economic and security threats associated with unreliable trading partners like China, arguing those threats endanger the American people far more than they would benefit from cheaply-made goods. One example of this approach is Sen. Marco Rubio’s (R-Fla.) extensive China plan, released in February 2019, for a more aggressive U.S. response to China’s strides for global dominance. This plan came amidst a growing bipartisan consensus on the need to protect strategically important industries for both national security and economic interests.

Safety And Supply Concerns Before Coronavirus: U.S. regulators have expressed concerns about the safety and efficacy of Chinese-made pharmaceuticals, cautioning that their quality control and health standards are lower than those at U.S. facilities. Despite governmental warnings that the Chinese government is “inadequately resourced to oversee thousands of Chinese drug manufacturers” and, thus, imperil drug safety, the U.S. still sought its most common and needed drugs from China. Even prior to the coronavirus outbreak in the U.S., experts warned that problems in China could cause severe shortages of approximately 150 drugs upon which Americans rely, and the U.S. Department of Commerce reports that large majorities of over-the-counter and basic prescription drugs come from Chinese manufacturers, including many commonly used, low-cost generics.

However, the challenge is much greater than cost competition. Among the most glaring issues facing the U.S. in biomedical innovation is the significant amount of raw materials necessary to develop vital cell and gene therapies that is produced in China. Despite the FDA requiring these therapies be developed in the U.S., American companies are still relying upon China to provide the raw materials for life-saving treatments and cures. Indeed, as STAT notes, “the number of facilities making [so-called active pharmaceutical ingredients] in China has more than doubled since 2010.”

What Policies Are On The Horizon?

Congressional Action To Stop China From “Weaponiz[ing]” Drug Exports: Lawmakers on both sides of the aisle now fear China’s ability to “weaponize” drug exports, which could leave Americans with diminished access to critical pharmaceuticals. Sen. Tom Cotton (R-Ark.) and Rep. Mike Gallagher (R-Wisc.) introduced the Protecting our Pharmaceutical Supply China from China Act to address this challenge. The bill would “prohibit pharmaceutical purchases from China or products with active pharmaceutical ingredients created in China” and “create transparency in the supply chain by instituting a country of origin label of all imported drugs.” To alleviate some of the new burdens on American manufacturing, the bill would also provide economic incentives for manufacturing drugs and medical equipment in the U.S. Meanwhile, Sen. Marco Rubio (R-Fla.) joined forces with a bipartisan group of senators, including Sen. Elizabeth Warren (D-Mass.), to introduce the Strengthening America’s Supply Chain and National Security Act, which would “combat America’s supply chain risk and dependence on China for pharmaceuticals.”

Trump’s Huge Pharma Deal: In May, the Trump Administration assigned one of the largest-ever government contracts from the Biomedical Advanced Research and Development Authority to Richmond, Va.-based Phlow Corp., now tasked with producing generic medicines and pharmaceutical ingredients necessary to treat COVID-19 but that are currently made overseas, particularly in India and China. The contract, which could total upwards of $812 million over the next decade, is a “historic turning point in America’s efforts to onshore its pharmaceutical production and supply chains,” President Trump’s trade adviser Peter Navarro explained, arguing the project “will not only help bring our essential medicines home but actually do so in a way that is cost competitive with the sweatshops and pollution havens of the world.” 

Buy American Iron And Steel … And Maybe Drugs: The Phlow deal isn’t the Trump Administration’s first effort to return manufacturing to the U.S. In July 2019, President Trump issued an executive order to strengthen “Buy American” laws. According to the American Action Forum, the order declared that “55 percent of the cost of manufactured domestic end goods must be made in the United States (up from 50 percent),” and, “The order further strengthened domestic requirements for iron and steel products.” According to a statement from Trump trade czar Peter Navarro in May 2020, President Trump is considering expanding this policy further to include “medical products and pharmaceuticals.” Navarro says this step would need to be accompanied serious deregulation to make it easier for pharmaceutical companies to do business in the U.S.

“Made In America” Sounds Good, But It Comes With Tradeoffs.

Supply Chain Reliability And Trade Consequences: Some critics of applying the so-called “Buy American” policy to pharmaceuticals say they’re worried that a supply chain that is not diversified could cause shortages and real problems in emergencies. According to a letter from the U.S. Chamber of Commerce and dozens of biomedical and other business groups, efforts to return manufacturing of health-related goods are worthwhile, but, “The United States simply does not produce all of the raw materials or intermediate goods that are essential to drug development,” and the policy “would only exacerbate the supply shortages.” The groups also expressed concern that, “as the world’s most innovative economy, the United States cannot shut itself off from the rest of the world. Turning our backs on trading partners during a crisis could damage our relationships long after this pandemic ends. If we implement localization requirements, many of our trade partners would assuredly follow our lead.”

Costs Passed To Patients: More than 250 economists signed a National Taxpayers Union letter expressing concern that a “Buy American” policy for biomedical products could make vital care more expensive for patients in the U.S. and harm our trading position with partners around the globe. The letter also notes, “A Buy America directive can also hamstring the ability of U.S. pharmaceutical and medical equipment manufacturers to meet our future needs if firms are denied access to essential foreign supplies.”

Meanwhile, the Pharmaceutical Research and Manufacturers of America says that building a single new biopharmaceutical manufacturing facility can take 5 to 10 years and cost as much as $2 billion, meaning increased investments by these companies are passed on to consumers. The American Action Forum has also warned about the economic costs, saying that any executive action would make only a minimal impact on purchasing via federal health care programs while driving up the costs and reducing the accessibility for many more consumers.

Risks to Intellectual Property: A common complaint among critics of a “Buy American” biomedical manufacturing policy is that it could devalue the intellectual property of researchers and companies who invested time and money into developing pharmaceuticals and vaccines. Their fears are well-founded in the context of the current pandemic, as anti-patent groups are already questioning how it will be possible to ensure equitable access to a future coronavirus vaccine if the companies producing the vaccine maintain the intellectual property, and researchers are facing mounting pressure to take the Open COVID Pledge to contribute their findings towards developing coronavirus treatments without maintaining intellectual property claims to their work. Amidst this pressure and scrutiny, actions by U.S. policymakers could force reactions by other countries that further undermines protections for the intellectual property developed by American pharmaceutical manufacturers, even though such protections are critical to creating life-saving treatments for COVID-19 and other illnesses the world faces.

Preparing For The Debate Underway

As support for bringing biomedical manufacturing home increases, so, too, do the challenges facing biomedical innovators. They must be prepared for the reputational risks associated with passing on investment costs to their customers, as well as the potential of losing their intellectual property rights. With threats arising from across the globe and across the political spectrum, pharmaceutical companies must be armed with the competitive intelligence necessary to advocate for their organizations and the patients they serve. Delve is ready to help.

Mitigating risks to international investments in health and life sciences

The Challenge: Local NGOs in key regions around the world were mounting sophisticated efforts to influence government policies and actions in ways that could undermine policies that are crucial to international investment in health and life sciences. The client was seeking to better understand who was funding and supporting these on-the-ground efforts so they could anticipate and mitigate those efforts.

The Solution: We began by producing a network overview report that detailed how international groups and global funders supported and directed the activities of local, seemingly-grassroots organizations. The overview report identified the key groups involved, which countries they were active in, the funding and other technical and legal support they provided, and how the groups at various levels coordinated and collaborated to influence national government and multilateral policies.

We then stood up an ongoing monitoring program informed by the network overview to provide regular analysis on activists messaging and influence efforts, collaboration among the various groups, and communication with national government and multilateral officials.

The Result: The network overview helped the client understand the nature and scope of the challenge they were facing. The monitoring alerted the client to issues before it was too late to mitigate their impacts.

Pharmaceutical company facing inexplicable opposition to a next generation drug

Challenge

A pharmaceutical company had developed a next generation treatment for a significant life-threatening disease. The company’s engagement with patient advocates and other stakeholders had proven mostly successful and won them significant support for the future release of this drug. However, there was one very vocal organization that vociferously opposed this next generation treatment at the FDA and elsewhere.

Solution

We were engaged to help the firm understand the motivations of this opponent and provide a roadmap for overcoming this opposition in order to successfully win approval for this lifesaving drug. Through our research, we exposed this group’s true motivation for breaking from other stakeholders and opposing the drug. We discovered that the main source of revenue for this organization was treatment clinics that used the current generation of drug treatments that aided but did not prevent the disease. The organization had a history of similar controversy and loud objections that could reduce their credibility, as demonstrated by the range of key voices among patient advocates and other stakeholders we were able to identify who were highly critical of this organization.

Results

The materials and insights we provided allowed the pharmaceutical company to build a narrative that marginalized the organization and successfully overcame their objections.

Rx For Lower Drug Prices

TL;DR: RX For Lower Drug Costs, Donation Protestations, And Facts And Credibility

RX For Lower Drug Costs, Donation Protestations, And Facts And Credibility

Rx For Lower Drug Prices

Here’s what you need to know…

President Trump’s rhetoric toward drug companies, which he has accused of “getting away with murder,” has been heated at times. That is why the industry and others in the health care space were watching closely when the Administration’s plan to lower prescription drug prices was unveiled last Friday. The plan, entitled “American Patients First,” would be a step to fulfilling the President’s campaign promise to reduce the costs that U.S. patients pay for their medications, which are the highest in the world. Here is what you need to know about the plan:

  1. What The Plan Does: Despite the President’s past rhetoric and initial industry fears of “biting” action, the plan included few specifics that would immediately impact prices and no large reforms to the way the system currently operates. The plan seeks to“increase competition, improve negotiation and create incentives to lower list prices of prescription drugs and out-of-pocket costs for consumers,” and some of the ways it proposes to do that is by implementing rebate-sharing in Medicare drug plans (an idea supported by the Obama Administration), promoting generic versions of drugs, including drug pricing in trade negotiations with foreign countries, and requiring manufacturers to publish prices in advertisements. After Trump’s plan was criticized for being light on substance, Health and Human Services Secretary (HHS) Alex Azar briefed reporters on concrete actions he can take as HHS Secretary “with [his] pen” to make changes to the pharmaceutical marketplace without Congressional approval, suggesting the Administration’s seriousness about ultimately backing up its rhetoric.
  2. The Industry’s Reaction To The Plan: The gravest concern for the industry was that the proposal would allow the federal government to negotiate lower Medicare drug prices directly with insurance companies. When this did not come to pass, biotech and pharmaceutical stocks went soaring, as well as those of the pharmacy benefit managers like Express Scripts and CVS – “middlemen” previously condemned by the President. While drug companies that engaged in lobbying the executive branch in hopes of helping shape the plan may be relieved in having been spared from drastic changes to the operating landscape at this time, there is a possibility that the President may diverge from his current course, meaning that companies should continue to remain vigilant in monitoring developments in this policy area.
  3. What Remains Unclear Going Forward: The timeline for the implementation of the plan’s policy changes remains uncertain, as is the extent to which the HHS Secretary will use his pen to implement proposed changes in the marketplace. Because of this, parts of the industry are already signaling a more public lobbying campaign in the coming months while the plan is being debated. Particularly in the runup to the midterm elections, the industry may be a prime target for further public shaming, as well as more robust regulatory attention from both the Administration and Congress, that may impact research and development efforts and raise the specter of greater political risk.

There is no “silver bullet” to bring down the costs of drug prices, especially when many Americans have unrealistic expectations regarding the trade-offs that would be required to implement policies to lower them. As long as these expectations persist, actual policy proposals will pale in comparison to the rhetoric used in the public arena and contribute to an operating landscape fraught with political and reputational peril for the industry.

News You Can Use

DONATION PROTESTATIONS

The Bay Area has become one of the wealthiest regions in the country and many tech moguls have already pledged to give away much of their fortunes, yet how some have chosen to donate their wealth has attracted scrutiny due to the potential benefits they receive in doing so. The Atlantic investigated the increasing popularity of a donor-advised fund, which is a certain type of charitable account that allows “donors to receive big tax breaks for giving money or stock” with “little transparency and no requirement that money put into [the account] is actually spent.” The rise in use of these funds has also correlated to a drop in donations to more traditional charities and private foundations in the Bay Area.

However, supporters of donor-advised funds point to the benefits of the accounts, which are better-equipped to accept non-liquid assets like stock, reduce the costs of operation needed by traditional nonprofit organizations, allow wealth to accumulate and grow like a charitable savings account, and incentivize people to get more bang for their philanthropic buck as opposed to giving more money in taxes to the federal government. So, while donor-advised funds may become another front in the public affairs campaign against Silicon Valley or the wealthy, as with all narratives in the public arena, there is more than one side to this story.

ROBOTS, CHINA, OR SOMETHING ELSE?

If you thought you knew the cause of the decimation of manufacturing jobs in the United States, think again. In fact, you would not be alone. Although economists’ popular consensus is that Chinese trade is the leading cause, a key expert disputes this consensus, pointing to research he recently posted that links job loss in manufacturing to the displacement of jobs resulting from automation.

China is blamed for the decline of the manufacturing sector largely based on a body of work that shows China’s 2001 entry into the World Trade Organization coincided with stalled growth in the American manufacturing economy, but Carl Frey – the Oxford economist whose study found that automation still has “a significant impact” while controlling for Chinese trade – disagrees, based off of his findings from examining automation anxiety and the 2016 election. For those trying to highlight the benefits of free trade in an operating landscape where consensus is constantly evolving, and where we all at times have only partial information, a competitive advantage that makes sense of the mass of information flows available is more important than ever in achieving their policy objectives.

FACTS AND CREDIBILITY

Much of the focus on curbing the rise of fake news has been on top-down government regulation of tech companies and their platforms, but to curb fake news in favor of a more elevated, fact-based debate may instead require a grassroots approach. Felicia Cravens is a conservative activist who started the Unfakery Facebook page, which hunts for fake news, fake profiles, baiting spammers from overseas, and other forms of misinformation targeting conservatives online.

Since founding the group, Cravens has attracted like-minded conservatives from across the country who have credibility with their side of the political spectrum – which Snopes, PolitiFact, or Media Matters for America may not – to take a discerning view of the facts and context of articles and news shared online, lead where they may, and push back on misinformation by sharing credibly-sourced links. Besides demonstrating a way to curb fake news online without federal regulation, which ultimately stifles competition and benefits entrenched incumbents, another aspect highlighted by Unfakery’s work is that credibility is an integral aspect of leveraging facts to gain a competitive advantage. 

THE “CUT CUT CUT” LIST

The Executive Office of the President’s (EOP) Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions was recently released, and to help you better prepare for what comes next, here is where you can review by agency the proposed deregulatory measures on deck. The “steady, bit-by-bit” deregulation by the Administration has continued persistently despite all of the noise, confusion, scandals, and unforced errors that undermine The White House’s work on a near-daily basis, and will likely have a profound impact on the regulatory landscape beyond the life of this Administration. While the President was ridiculed when he wanted last year’s tax reform law to be called the “Cut Cut Cut Act,” given the Administration’s continuing work to cut regulations, might we propose a simpler name: the “Cut Cut Cut” List.