Food & Health

Food & Health

Research

Adam Thierer | Jul 12, 2016
Do citizens have the right to determine their own courses of treatment and to use medicines and devices that they believe could improve their health? In other words, do patients have a “right to try” medicines and devices that can help them?
Jayson L. Lusk | Jun 24, 2016
Since its inception more than a century and a half ago, the US Department of Agriculture (USDA) has experienced enormous growth in both size and complexity—as has the industry it seeks to serve. Today the USDA is among the largest federal employers and its 2014 budget exceeded $160 billion. Its spectrum of activities span from the protection of rural farm interests to urban food assistance. Consequently, the department is the target of a wide range of interest groups besides farmers, including food assistance advocates and advocacy groups interested in issues such as obesity, animal welfare, food safety, the environment, and more. The disparate agendas of these groups make it difficult for Congress to assemble a unified policy package each time USDA’s programs are due for reauthorization. The latest reauthorization, the Agricultural Act of 2014, was signed into law two years late in February 2015. In a new study for the Mercatus Center at George Mason University, economist Jayson L. Lusk documents the changes in American agriculture since the USDA’s inception and the expansion of the department’s mission. Much of the USDA’s regulation is outdated, wasteful, and conflicting.
Sherzod Abdukadirov, Scott King, David Wille | May 17, 2016
Over the past few years, the federal government and local governments have increasingly turned to “nudges” as solutions to many problems caused by behavioral biases. Such efforts often run into opposition owing to their paternalistic nature, but nonpaternalistic nudges can be equally effective at improving consumers’ choices. In contrast to paternalistic nudges, nonpaternalistic policies do not impose policymakers’ errors on consumers if policymakers misdiagnose the underlying behavioral bias, and they thus avoid harming consumers by pushing them toward suboptimal choices.
Christopher Koopman, Thomas Stratmann, Scott Eastman | May 17, 2016
Certificate-of-need (CON) programs are state laws that require government permission for healthcare providers to open or expand a practice or to invest in certain devices or technology. These programs have been justified on the basis of achieving several public policy goals, including controlling costs and increasing access to healthcare services in rural areas. Little work has been done, however, to measure what effects CON programs have on access and distribution of healthcare services. Two recent studies that examined the relationship between a state’s CON program and access to care found that these laws failed to achieve their stated goals.
Eric Sun, Kelly Ferguson | Apr 20, 2016
In 2002, Congress passed the Medical Device User Fee and Modernization Act, with the aim of pushing the FDA to speed up the approval process for medical devices. This law levied large user fees on medical device manufacturers in exchange for the promise of shorter review times by the FDA. Whether the act has resulted in shorter review times has been unclear. This study conducted a regression analysis to address this question, using data on FDA review times for devices seeking approval between 1991 and 2012.
Jerry Ellig, James Broughel, Spencer Bell | Mar 09, 2016
For more than three decades, presidents have required executive branch regulatory agencies to identify the systemic problems they wish to solve when issuing major regulatory actions. The first principle in Executive Order 12866, which governs executive branch regulatory review, is that an agency shall “identify the problem that it intends to address (including, where applicable, the failures of private markets or public institutions that warrant new agency action) as well as assess the significance of that problem.” This principle reflects the sensible notion that before proposing regulation, regulators should understand the root cause of the problem the proposed regulation is supposed to solve.

Testimony & Comments

Richard Williams, Michael L. Marlow, Edward Archer | Apr 12, 2016
The case examined here is the package of regulations that met the initial legal requirements provided by the Nutrition Labeling and Education Act of 1990 (NLEA, Public Law 101-535). This act gave the FDA the authority to require nutrition labeling of most foods regulated by the Agency and to require that all nutrient content claims (e.g., “high fiber” or “low fat”) and health claims be consistent with agency regulations.
Todd Nesbit | May 18, 2015
A new public interest comment by economist Todd Nesbit, written for the Mercatus Center at George Mason University, demonstrates that the proposed rule fails to show a need for the rule, fails to properly assess the benefits of the rule, and does not consider alternatives to the rule. The regulatory impact analysis should be improved to account for these failures.
Sean Mulholland | Feb 16, 2015
Under the authority of the Clean Water Act (CWA) of 1972, the Environmental Protection Agency (EPA) is proposing new technology requirements for all new and existing dental practices that use dental amalgam, which is the main source of mercury discharges into publicly owned treatment works (POTWs). The proposed rule would require dental offices to use amalgam separators and best management practices (BMPs) for capturing mercury and other metals before they are discharged into POTWs.
Michael L. Marlow | Jun 27, 2014
This public interest comment estimates the range of annual benefits (costs avoided) associated with e-cigarette use as $15.6 billion to $49.2 billion and that 2.4 million to 6.4 million smokers may potentially become ex-smokers by using e-cigarettes. Estimates are based on a range of quit rates from the current literature and assume all smokers interested in quitting use e-cigarettes. Even a fraction of estimated benefits (costs saved) are substantial. These estimates indicate the FDA is jeopardizing public health by not estimating benefits associated with e-cigarettes using data from readily available studies on their efficacy as harm-reduction tools.
Todd Nesbit | Mar 04, 2014
It is not clear based on the FDA’s analysis whether its proposed rule is in the best interest of society. FDA makes no attempt to estimate the benefits of the regulation, and the analysis of the costs is very likely biased downward due to questionable assumptions and omissions. Further, changes of behavior are only selectively considered—discussing them when logically leading to benefits but dismissing the costs associated with those changes in behavior.
Richard Williams | Jun 20, 2011
This comment analyzes the Food Safety and Inspection Service’s proposed rule concerning mandatory inspection of catfish and catfish products.

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The 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.

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Please join the Mercatus Center at George Mason University for the first of a two-part series reviewing the basic features of the Regulatory Flexibility Act and related amendments and how regulatory flexibility analysis is intended to work in the context of federal rulemaking.

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Keith Hall | Aug 08, 2013
Keith Hall, a researcher at George Mason University’s Mercatus Center, finds that nearly all jobs created in the past few months have been part-time gigs.
Keith Hall | Aug 07, 2013
Moody’s Mark Zandi and the Mercatus Center’s Keith Hall, have suggested that the law’s effects can be seen in recent jobs data, after a few months of high part-time job creation.
Jerry Ellig | Jul 30, 2013
Jerry Ellig discusses White House efforts to shape behavior…
Tyler Cowen, Alexander Tabarrok | Jun 12, 2013
His goal is to put online in the next 5 to 10 years an entire series of courses that cover the basic sweep of his field.
Donald J. Boudreaux | Jun 27, 2012
Don Boudreaux explains how industrial capitalism has been the greatest anti-pollutant.
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