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Richard Williams

Richard Williams

Richard Williams is vice president for policy research, director of the Regulatory Studies Program, and a senior research fellow at the Mercatus Center at George Mason University. He is an expert in benefit-cost analysis and risk analysis, particularly associated with food safety and nutrition.

Articles by Richard Williams

The ‘I’ Factor

September 4, 2018

A provocative new study projects more car wrecks and worse food safety in the future because of climate change. According to the authors, higher temperatures are more hospitable to food-borne pathogens (like salmonella) and lead to poor driving. In addition, “exposure to hotter temperatures reduces the activity of two groups of regulators — police officers and food-safety inspectors — at times that the risks they are tasked with overseeing are highest…
Continue reading: The ‘I’ Factor

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How to Make Science Trustworthy Again

July 24, 2018

The academic literature on the topic is clear: a lot of academic literature is wrong. Scientific studies routinely struggle with bad modeling, faulty data, and bias. So how do we fix that? Richard Williams has some ideas, which he outlines in RealClearPolicy. 
Read it here: How to Make Science Trustworthy Again

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Will Food Labeling Protect Us?

June 27, 2018

The dairy and meat industries are anxious to protect themselves from vegetarian competitors that are increasingly approximating their taste. Are food identity laws the answer? Richard Williams writes that the application of these regulations is a dubious approach. 
Read more: When it comes to food, what’s in a name?

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On Year-End Government Waste and What It Points To

December 12, 2017

"We have a lot of year-end money left and we need your help to spend it." I had been at the Food and Drug Administration for just two months, in September 1980, when that request came to me from an office manager. If we didn’t spend it, I was told, the money would be turned back in to the Treasury and we would end up getting our budget cut.
Given our nation’s fiscal situation 37 years later, you would think this kind of wasteful spending would be a thing of the past — and you’d be wrong. It only accounts for a small part of our annual deficit, but every member of Congress who is concerned about our mounting debt ought to be outraged.
"What should I spend it on?" I asked at the time.
"Anything really, as long as it is somehow work-related." Texas Instruments had a fancy new calculator, so

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Helping Small Businesses Comply with Federal Regulations

July 7, 2017

All people who have ever dreamed of being their own bosses, opening their own businesses, or creating new kinds of businesses but who haven’t yet acted on those dreams are potential small business owners. But because these businesses do not yet exist, their owners don’t belong to any recognizable group. There is no guardian ad litem who protects their opportunities to be their own bosses.
Although the Regulatory Flexibility Act and the Small Business Regulatory Enforcement and Fairness Act (SBREFA) protect small businesses that “bear a disproportionate share of regulatory costs and burdens,” there is no law, and, in fact, no constituency, to protect potential entrants. After all, they don’t even know they are potential entrants until they try, like Senator McGovern, to open their own

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Putting Faith in Improved Nutrition Labels Still Misguided

June 28, 2017

On June 13, the FDA indefinitely delayed several sugar and calorie labeling requirements made famous by Michelle Obama during the previous administration. In response, labelling advocates have accused the Trump administration of, as the Center for Science in the Public Interest’s Jim O’Hara put it, “denying consumers critical information they need to make decisions.”
Yet in fact, while many Americans need to cut back on sugar and calories, these food label changes will not help consumers one bit.
Former FDA Commissioner David Kessler once held a news conference to announce 21 proposed labeling regulations over the following year, and one concerned reporter asked, “What are we supposed to do before that?” To his credit, Dr. Kessler suggested they eat more fruits and vegetables.
Regardless,

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Gottlieb's FDA Should Focus on Food Safety Policy

June 7, 2017

Some observers have expressed concern about the recent appointment of Scott Gottlieb as head of the Food and Drug Administration because of his past work with pharmaceutical companies. However, it’s important to remember that the FDA handles a lot more than drugs and biologics. In fact, addressing the Food Safety Modernization Act (FSMA) regulations will be a critical issue for Dr. Gottlieb. 
A review of economic analyses written by the FDA to support many of its regulatory decisions in implementing FSMA shows that there were much better options on the table than those selected — options that would have lowered the cost of these regulations. To take just one example, the FDA chose to target all produce with a food safety rule using FSMA. Had FDA regulators focused instead on only those

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Federal Regulation of Food Safety

August 17, 2016

Publication

Chairman Johnson, Ranking Member Carper, and members of the committee, thank you for inviting me to testify on the impact of federal regulations on America’s food and agriculture. Federal regulations affecting food are intended primarily to protect public health by ensuring that food is safe. These regulations affect both the cost of growing and manufacturing food and the ever-changing makeup of the food supply. According to President Clinton’s Executive Order 12866, food safety regulations (like all regulations) must be based on “the best reasonably obtainable scientific, technical, economic and other information concerning the need for, and consequences of, the intended regulation.” Agencies are also legally responsible for ensuring that the science and analysis within these regulations satisfies quality, objectivity, utility, and integrity requirements. Yet far too often, federal food regulations conform to none of these requirements. As a result, food regulations cost far too much and accomplish far too little, far too often. My testimony today will touch on these problems with our current food regulation system. I will provide several examples of failed food safety regulations and explain why there are better approaches to solve food safety problems than regulations that try to anticipate every conceivable problem.

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Get Bureaucrats out of Medical Decisions

July 27, 2016

Expert Commentary

The stories are heartbreaking and horrifying. People who are dying and just want to live go before the Food and Drug Administration in hopes that the FDA will listen to them and approve a drug that may give them a chance to live.But as a former FDA medical officer recently revealed, when the FDA holds a public speaking session where these desperate people come to make their case at advisory committee meetings, “It is all for show. I can recall my FDA supervisors and colleagues checking their emails, doodling, texting, and the like to avoid listening to individuals who would often travel great distances to pour out their hearts to the advisory committee and FDA reviewers, literally begging them to approve a new drug.”Yet Right to Try legislation, which allows terminally ill patients to access drugs that have only passed the safety tests required by FDA, is now the law in 28 states (and introduced in 15 more). As the former FDA official said, “It makes sense for people who don’t understand the complexities of the drug development process.”By making sense of course, he was referring to the pleading for the chance to save a life.

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Does FDA Funding Increase Drug and Medical Device Innovation?

July 15, 2016

Publication

INTRODUCTIONThe US FDA receives funding through the general fund and user fees. Additional funding comes from the regulated industries. Specifically, the drug industry funds FDA through the Prescription Drug User Fee Act (PDUFA), and the medical device industry funds FDA through the Medical Device User Fee Act (MDUFDA). Both acts are considered a success for requiring FDA to improve approval time for drugs and devices. However, decreased approval times have not resulted in more drug and device innovation.  In fact, the same number of products are still submitted for approval to FDA. They are just approved more quickly. FDA does not have an incentive to actually increase innovation—its only incentive is to meet its MDUFA and PDUFA approval times to keep its funding flowing. The expense of putting drugs and devices through this system is almost unimaginable. The cost of bringing low- to medium-risk 510(k) medical devices to market averages $31 million, $24 million (75 percent) of which is dedicated solely to attaining FDA approval within an average of about six months. Any significant improvement to the device requires reapplication. For higher-risk medical devices where there may be significant health gains, the costs are about $94 million, $75 million (80 percent) of which is dedicated to attaining FDA approval.

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Time to Celebrate Red, White, Blue — Not Red Tape

July 1, 2016

Expert Commentary

The Fourth of July is marked by Americans all across the country celebrating our nation’s independence with firework displays and backyard barbecues. And yet, in the 240 years since we declared our independence from Great Britain, we have slowly built up a government bureaucracy that limits the very freedom we celebrate each year. As Thomas Jefferson once wrote, reminding Americans to be just as wary of our own government as we were of the British crown, from which we gave up so much to be separate: “When all government, domestic and foreign, in little as in great things, shall be drawn to Washington as the center of all power, it will render powerless the checks provided of one government on another and will become as venal and oppressive as the government from which we separated.” The absence of self-governance was precisely what ignited a revolution in the American colonies. It wasn’t the taxation of tea that caused Colonial outrage; it was the fact that the favored British company, the East India Company, got a tax break. Americans feel disconnected from the decisions made within the confines of the Washington, D.C., beltway. Most people (three out of four) express this fragmentation by responding negatively to the question of whether the government is on “the right track.

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The Brexit Vote is a Referendum on the European Union’s Thousands of Stifling Regulations

June 23, 2016

Expert Commentary

How many people does it take to change a lightbulb in England? Depends on what the European Union (EU) says. A priest in Suffolk, England used to hire a man to climb a ladder to change his lightbulbs. That was fine until the European Union Working at Heights Directive banned this activity so that now the priest must spend1,700 pounds (about $2,000). In the next seven years, they added an additional 12,000 regulations (about 1,700 per year). The vast majority of them (only about 1 in 200) have no analysis of the likely impacts. This is problematic as the costs of EU regulations are estimated to be above 70 percent of the costs of all regulation.  But relative to the pace of regulations put out by the U.S. federal government, the EU could be viewed as highly restrained. In 2015 alone,  the United States put out 3,378 rules (with another 2,234 under consideration). How do we end up with so many regulations, including the ones that may cause a church to close down? The standard answer in economics is "concentrated benefits and dispersed costs." What that means is that there are always groups—whether they are industry groups or activists groups—who gain a lot from an individual regulation, meaning they get the concentrated benefits.

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Overregulated Britain

June 22, 2016

Expert Commentary

Is the "Brexit" – the possible departure of the U.K. from the European Union – a major sign of a populist revolt against bureaucracy? It would seem so, and the warnings of potential consequences seem dire. Some argue that if the United Kingdom leaves the EU, then there will be a bureaucratic regulation-fest to make sure that no area currently regulated goes unregulated. But that would be nothing new for those long suffering under the weight of British regulations as ably chronicled in the humorous yet depressing book, "How to Label a Goat: The Silly Rules and Regulations That Are Strangling Britain." Many argue that Britain would be fiscally at risk, yet a recent paper from the Mercatus Center at George Mason University shows that, if we had frozen regulations in the United States at the 1980 level, each person in the nation would be $13,000 richer today. The British government believes that the cost of just the top 100 EU regulations is about $47 billion. If Britain were to leave, someone would actually have to ensure that there wouldn’t be a free-for-all for those who favor regulating everything imaginable.

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Why the New Nutrition Labels Won’t Work

May 26, 2016

Expert Commentary

The Food and Drug Administration’s Office of Nutrition has a tendency to cling to bad policies and reject any new ideas. So it was back in the 1990s, and so it is now—a couple of decades later. The latest evidence came Friday when it released a long-awaited proposal to fix the nutrition label. The proposal received widespread praise, including by the first lady and the FDA commissioner who touted it as a “valuable resource.” Just one problem: The idea of a label makes much more sense on paper than it does in real life. Consumers don’t really use nutrition labels to eat healthier because it’s too complicated to try and combine all of the information into one decision. Perhaps even worse, what we know about the relationship between diet and disease is almost entirely based on data that come from people trying to remember what and how much they ate. Their memories are terrible, and subsequent study has shown that the data are flat wrong. The FDA needs to give up on this failed policy and try other ideas that help consumers make healthier choices. How am I so sure that the nutrition facts panel has been a failure? Because I made all of the upbeat predictions about how helpful it would be when, in 1993, we implemented the Nutrition Labeling and Education Act of 1990.

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Should the Government Have a Monopoly on Public Health?

April 1, 2016

Expert Commentary

Why is it that we confuse “public health” with “public health agencies?” According to the Centers for Disease Control (CDC) “Public health is the science of protecting and improving the health of families and communities through promotion of healthy lifestyles, research for disease and injury prevention and detection and control of infectious diseases.” Under that definition, we may all be in the business of public health. Each of us, by examining our own lifestyles, tries to determine the healthiest way to live. Mothers and fathers try to improve the health of their families. However, we also have public health agencies, including the CDC, the U.S. Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration (FDA). Too often, we look to agencies to solve all public health problems rather than just the problems for which they have the mandate—and possess the necessary information—to solve. Obesity is a prime example of this. Another example, likely just as important as diet, is the government defining the “safety” and “effectiveness” for drugs and medical devices. While this may seem like the job for an impartial scientific agency, a deeper look at this issue reveals some serious problems with granting the FDA a monopoly on these definitions. Let’s start with effectiveness.

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David vs. Godzilla, OIRA and the Federal Agencies

March 15, 2016

Publication

Chairman Meadows, Ranking Member Connolly, and members of the committee, thank you for inviting me to testify on ways to improve transparency and accountability at the Office of Information and Regulatory Affairs (OIRA).  This small agency, established in 1980 by President Carter to “regulate the regulators” and to give “OMB final word on many of the regulations issued by our government,” has largely failed to achieve either goal. The myth persists that OIRA is a “little-known but extraordinarily powerful” agency that has been a “bottleneck” for protective regulations. The data, however, simply do not support this notion. There are three main issues that I will cover in my testimony: Other federal agencies, and their associated rulemaking, have grown manyfold in the last four decades, but OIRA staffing has shrunk in the same time period, rendering oversight by OIRA spotty, at best. OIRA cannot perform its duties effectively in this imbalanced state.  OIRA also lacks necessary expertise in one key area. Recommendations for reform can help rebalance the relationship between OIRA, stakeholders, and federal agencies, while improving government accountability and transparency in rulemaking.

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The Food and Drug Administration Needs to Change After 110 Years

February 5, 2016

Expert Commentary

A supercentenarian is a person who has lived passed their 110th birthday. We celebrate that for people, but it’s not clear that we should celebrate it for a federal agency like the Food and Drug Administration , which turns 110 this year.  It’s certainly time to re-evaluate precisely what such an agency ought to be doing, not to mention what it should not be doing. Two things that federal agencies like the FDA should avoid in particular are scandals and poor outcomes. Typically the scandals are what dominate the news, but what may be most damaging to the country are the poor outcomes from these agencies. Some, such as the chronically poor care at veteran’s hospitals, are easy to see and document. These sorts of highly visible scandals and outcomes outrage the public and Congress – and action usually follows – but there’s no parallel outrage for poor outcomes that are widely distributed and difficult to attribute.

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Seat Belts Won’t Keep Kids Safer on School Buses

December 29, 2015

Expert Commentary

As the snowy season descends upon us, it’s important to make sure our vehicles are as safe as possible, including our school buses. For many people, that means considering adding seat belts to school buses. But would that really make children safer? In November, child safety on school buses was discussed again by the Department of Transportation at a meeting of the National Association of Pupil Transportation. The association is responsible for the 500,000 school buses that ferry our children to and from school 240 days a year, including summer school. The issue of seat belts on buses has been debated for 40 years. Like a lot of issues, on the surface the answer seems not just obvious but morally justified. Seat belts save lives, so why wouldn’t we put them on school buses? But before relying on moral arguments to drive public health policies, we owe it to the people we’re trying to protect to study whether or not the proposed policy will actually work. As it turns out, the National Highway Traffic Safety Administration has done just that.

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Congress and the FDA Are Blocking Medical Innovation

December 1, 2015

Expert Commentary

Where does innovation come from? The new devices for sale on Black Friday and Cyber Monday? It’s certainly not driven by the government. Rather, it’s all about tinkerers who ultimately drive scientific discoveries. No matter how smart our leaders are, they are never going to outperform the vast power of the millions of dabblers and dreamers in each of their individual pursuits. Tinkerers often don’t start with dreams of riches; they just see a better way. They are, as my Mercatus Center colleague Bob Graboyes describes it, on the frontier, not in the fortress. But lately, these tinkerers face too many obstacles to truly generate economic growth. Want to invent a medical device? The time, money and complexity of going through the Food and Drug Administration’s process is bound to discourage most. That’s why it’s so depressing to read about attempts to improve innovation with more central funding, guidance and big meetings. Is that really what we need to take advantage of the fantastic new sciences of robotics, nanotechnology, genetic manipulation and more to enhance our health? Certainly from Washington’s limited vision, all solutions must start and end within the 61 square miles of the District of Columbia.

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The Martian vs. The FDA on How to Science Stuff

November 11, 2015

Expert Commentary

“I’m gonna science the s#!t out of this planet.” So says the fictional character Mark Watney in the new sci-fi thriller, “The Martian,” which has now grossed a half-billion dollars worldwide. For every conceivable thing that goes wrong on the Red Planet, the botanist astronaut comes up with an answer. It’s a good thing Watney was on Mars, because he would find “sciencing” much more difficult on his home planet. Some of America’s most famous inventors felt like they also could overcome any odds. Benjamin Franklin invented bifocal glasses and the flexible urinary catheter. Jonas Salk invented the vaccine for Polio, a disease that put President Franklin Roosevelt in a wheelchair. Salk tested it on his own wife and three sons before testing it on the nation in 1954. Then there was Marion Donovan, the daughter of an inventor who grew up with her father’s can-do spirit of solving problems. She invented disposable diapers in 1950. Yet today, they might be classified as class 1 medical devices, like reusable menstrual pads, so she would have to pay a registration fee of $3,313. We celebrate inventors in this country and even have museums dedicated to them like the National Air and Space Museum and the American History Museum.

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GMO Labels Won’t Make Foods Safer, Only More Expensive

October 29, 2015

Expert Commentary

It’s been estimated that 70 to 80 percent of foods eaten in the United States contain ingredients that have been genetically modified. But labeling these foods is certainly not a food safety issue; there has never been a case of harm to people from GM products – ever. And it’s also not something that the FDA can legally do right now, because there is no scientific difference between GM foods and conventional foods. By the year 2025, the World Wildlife Fund estimates that two thirds of the world’s population will confront a water shortage and ecosystems will also suffer. One way to help mitigate this scenario is to promote the use of GM foods, which reduces the need for ploughing. This allows the soil to trap moisture and helps plants retain water. In some cases, this will make the difference between a harvest or crop failure. Some results show crop yields increasing by 4 to 8 percent in arid conditions with others suggesting gains as much as 21 percent. With nearly one person in every nine not having enough to eat on this planet, that’s a promising start. Another way that GM foods help us is that they use less pesticide. One study found that it reduced the quantity of pesticides by 37 percent and the cost by 39 percent.

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