Maybe the decluttering guru could clean up America’s messy regulatory code. Read more at InsideSources.Read More »
Articles by Richard Williams
Small businesses are suffering. Government shouldn’t be making it harder for them. Read more at the Pittsburgh Post-Gazette.Read More »
With hand sanitizer in short supply and alcohol distilleries ready to step up, the famously risk-averse FDA’s excessive precautionary standards could put lives in danger. Read more at The Hill.Read More »
During this pandemic, we could all use a beer or two, but the new federal dietary guidelines (based on bad data) tell us to stop at one. Read more at the Star Tribune.Read More »
During this pandemic, we could all use a beer or two, but the new federal dietary guidelines (based on bad data) tell us to stop at one. Read more at Newsday.Read More »
Richard Williams discusses why America is still a great country, even in an age of polarization.
Read more at InsideSources.
Richard Williams evaluates the different ways government agencies can reduce the regulatory burden on small businesses.
Read more at InsideSources.
Richard Williams and Nicolaus Tideman discuss how the FDA gets in the way of innovative treatments and how doctors should have discretion, especially during COVID-19.
Read more in Tribune News Service.
Richard Williams looks at modern comedians and how a comedian like Will Rogers could help in difficult times.
Read more at InsideSources.
Richard Williams discusses the danger of FDA restrictions on the production of hand sanitizer.
Read more at the Hill.
Richard Williams reflects on an important lesson taught by Mr. Rogers: neighborly trust is a good thing.
Read it at Inside Sources.
Richard Williams writes on the need to reform food nutrition labels, much as Canada has recently done.
Read the article on The Hill.
How will society respond to the emergence of lab-grown meat as a substitute for traditional meat? Richard Williams explores the issue in an opinion at the New York Daily News.Read More »
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
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
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?
"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
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
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.
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
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.Read More »
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.Read More »
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.Read More »
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.Read More »
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.Read More »
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.Read More »
Richard Williams talked about his concerns with the Food and Drug Administration’s (FDA) redesign of food nutrition labels. He assisted in the creation of the original label, which he says was not able to change consumers’ eating habits.
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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.Read More »
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.Read More »
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.Read More »