FDA & Health
From food to pharmaceuticals to medical devices, the safety of what is introduced into our bodies is one of our nation’s greatest concerns. The justified importance of food and drug safety to the consumer has led to a vast regulatory framework aimed at protecting Americans from danger, but these regulations often come with a price. What are the benefits and costs of this regulatory system and how can potential improvements better ensure safety while maximizing innovation?
In this paper, James Capretta argues that the current system for regulating the physician workforce is not flexible enough to ensure that enough doctors make it into the field to serve all patients. Mr. Capretta offers a number of reforms that, he argues, would streamline the educational and licensing processes for new and immigrating doctors.Read this paper
In this paper, Christina Sandefur argues that well-intentioned laws designed to limit wasteful spending, known as certificate-of-need laws, no serve mostly to allow market incumbents in healthcare to keep new entrants out of the market. This, she argues, is harmful to the public and stands in violation of state anti-monopoly laws.Read this paper
In this paper, Henry I. Miller argues that overweening regulation has forestalled development in major areas of biotechnology, from pharmaceuticals to agriculture.Read this paper
In this paper, Peter Huber and Roger Klein explore how adaptive clinical trials could transform how medicines are prescribed by doctors, allowing doctors to harness ‘precision medicine’ to develop better and more individualized treatment plans for their patients.Read this paper
The FDA currently bars any speech by the manufacturer of a drug describing or promoting a use of the drug for any use other than an on-label use — even if the information is entirely truthful and non-misleading and could help physicians better treat their patients. Is such a restriction compatible with the First Amendment? Can the FDA modernize and clarify its position on off-label communications? Christina Sandefur delves into these important questions.Read this paper
In this paper, Yevgeniy Feyman examines the effects of the employer-sponsored insurance tax exclusion on health insurance costs and proposes solutions that could lead to “a health insurance market that is accountable to patients, doesn’t push up health care prices unnecessarily, and one that provides a product that follows a person regardless of their employment situation.”Read this paper
In this paper, James Capretta analyzes Medicare’s fee-for-service payment systems, argues these payment systems have led to inefficiencies and fragmented care delivery, discusses the attempt by the Affordable Care Act to address these issues, and suggests other potential solutions.Read this paper
Experts explore the rationales behind telemedicine regulations and examine how reforms and lawsuits might transform how patients receive care.Listen to this podcast
Top experts dive deep into the legal issues surrounding the CDC’s eviction moratorium and the relief sought by both landlords and renters.Listen to this podcast
Professors Gregg Bloche, Larry Gostin, David Hyman, and Timothy Westmoreland discuss the current state of healthcare policy in the United States.Listen to this podcast
In this live podcast, experts debate which legal rules and institutions are best-suited to promote the development and commercialization of new drugs and vaccines.Listen to this podcast
Joel Zinberg joins the podcast to discuss a range of COVID-19 vaccine questions.Listen to this podcast
On November 19, 2020, RTP co-hosted an online event featuring Professor Julia Mahoney and J. Gregory Grisham.Listen to this podcast
An expert panel explores the potential of human ingenuity to solve the problems facing our health and the conditions necessary to make those solutions a reality.Listen to this podcast
On September 22, the Federalist Society’s Villanova Student Chapter co-sponsored a debate on Medicare for All with the Villanova Law Health Law Society.Listen to this podcast
Join us as the U.S. Department of Health and Human Services Deputy Secretary Eric Hargan discusses the role of his agency. Likely topics include COVID-19, as well as the agency’s regulatory reform efforts.Listen to this podcast
In this episode, Jim Capretta and Chris Pope examine the current process for educating, training, and licensing physicians in the US, with a focus on whether the current process is sufficiently flexible to adjust as needed to accommodate changing demand by patients.Listen to this podcast
In this episode, David Hyman, Roger Klein, and Shoshana Weissmann discuss potential regulatory reforms that could allow governments and private actors to be more responsive to public health threats.Listen to this podcast
In this episode, Jeff Stier draws on the experience of Impossible Burger to argue for light touch regulation on harm-reducing technologies.Listen to this podcast
Todd Gaziano (Pacific Legal Foundation) and Michael Edney (Norton Rose Fulbright) discuss the constitutional implications of the FDA’s 2016 rule on cigars and vaping products.Listen to this podcast
In this episode of Fourth Branch, Christina Sandefur (Goldwater Institute) discusses the First Amendment implications of regulating off-label promotion of medicines and medical devices by companies.Listen to this podcast
How do we intelligently allocate medical spending between specialized high tech tools and low tech devices?Watch this video
Professors Gregg Bloche, Larry Gostin, David Hyman, and Timothy Westmoreland discuss the current state of healthcare policy in the United States.Watch this video
Legal experts and business owners affected by COVID-19 restrictions weigh in on the debate over those restrictions.Watch this video
Though the average grocery shopper would never know it, the proliferation of vegan and non-dairy substitute foods has sparked a fierce debate over how food producers label their products.Watch this video
The creators of the award-winning documentary, They Say It Can’t Be Done, in partnership with the Federalist Society’s Regulatory Transparency Project, present It Can Be Done Live – a conversation between entrepreneurs, regulatory experts, and noted academics around creative and bipartisan solutions to global challenges to our shared future. The second of four panel events, It Can Be Done Live: The Future of Our Health, took place on September 17th, 2020.Watch this video
Due to the COVID-19 pandemic, hand sanitizer has been in high demand. The FDA has stringent regulations about the ingredients for hand sanitizer. This guidance was relaxed somewhat to allow more production from a variety of alcohol industries, such as fuel alcohol manufacturers. After these industries invested time and money preparing to produce hand sanitizer, the FDA revoked the initial guidance and dictated that all hand sanitizer must comply with the usual standards. Are the actions of the FDA justified out of a concern for safety, or should some regulations be re-evaluated in times of emergency?
T. Elliot Gaiser is an Associate at Boyden Gray & Associates PLLC.Watch this video
Certificate of need laws are state regulations designed to control medical costs. New medical facilities must be assessed and approved by a state board which determines whether such a facility is needed by the community.
Christina Sandefur of the Goldwater Institute explores whether such laws have successfully controlled costs or if they have hindered the competition required to balance healthcare prices.Watch this video
Did Food and Drug Administration (FDA) regulations hamper the fight against COVID-19 at a critical juncture? In this short video narrated by Roger Klein, we explore the relationship between the FDA and the CDC in regulating and conducting diagnostic tests.
In 2016, in response to the Zika virus, the FDA designated the Center for Disease Control and Prevention (CDC) as the country’s only diagnostic test manufacturer. In early February 2020, the CDC was ordered to distribute tests for COVID-19 which were faulty and had to have results verified by the CDC laboratory. Only in mid-March 2020, did the CDC loosen regulations which then allowed private hospitals and labs to develop and conduct their own tests.
Could more have been known about the disease at an earlier date if private testing and treatment had been allowed and encouraged? Should the COVID-19 emergency force us to reevaluate the purpose and use of public health regulations and policies?Watch this video
In this Fourth Branch video, legal and healthcare experts debate how federal and state agencies should approach the regulation of e-cigarettes. Should vaping be encouraged as a harm-reduction strategy, with the aim of reducing cigarette-related deaths, or should regulators seek to restrict the availability of e-cigarettes, with the aim of preventing nicotine addiction? This video explores these questions and more.Watch this video
The application of EU-style chemical regulation in emerging economies would reduce the number of jobs available and increase the cost of living in already struggling communities. A risk-based approach like that of the United States is the best way for Brazil, India, and other countries to raise standards of living while protecting their citizens.Read this article
Sometimes well-intentioned, restrictive government interventions are backward-looking problem-solving tools. Too often, they fail to deliver on the promises made to justify their costs, both in terms of unintended consequences and their cost to individual freedoms.Read this article