FDA & Health

Does President Trump Have the Authority to Pause and Modify the Medicare Drug Price Negotiation Program?

Since its inception, the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program has been contentiously debated.  For example, several…

Explainer Episode 70 – Food and Drug Administration v. Wages and White Lion Investments, LLC

On July 2, 2024, the US Supreme Court granted certiorari in the case, Food and Drug Administration v. Wages and…

Explainer 67 – Veterans’ Benefits Reforms: How Healthcare Influences Foreign Policy

The Regulatory Transparency Project’s Fourth Branch Podcast presents Explainer Episode 67. In this Fourth Branch Explainer podcast, health policy experts…

Explainer Episode 65 – Reviewing Michael Cannon’s Book “Recovery”

In this RTP explainer episode 65, we are joined by Michael Cannon, Director of Health Policy Studies at the Cato Institute, and Christina Sandefur, Executive Vice President of the Goldwater Institute to discuss Michael Cannon’s new book, Recovery. 

Explainer Episode 62 – FDA’s Regulation of Laboratory Developed Tests

For many years FDA has claimed the authority to regulate Laboratory Developed Tests, that is tests that are designed, produced,…

Explainer Episode 61 – FDA & Flavored E-cigarettes – Discussing Triton v. FDA

The approach the FDA has taken to regulating e-cigarettes and vape products, particularly those that are flavored, has been the…

Litigation Update: Bella Health and Wellness v. Weiser

In Bella Health and Wellness v. Weiser, a Colorado faith-based healthcare provider is challenging a recent Colorado law banning a treatment commonly…

Explainer Episode 55 – 10 Years On: The Impact and Effects of AMP vs. Myriad

On June 13, 2013, the Supreme Court issued its unanimous decision in Association for Molecular Pathology v. Myriad Genetics Inc….

Explainer Episode 53 – Biologics, Biosimilars, and the Two-fold U.S. Approval Framework’s Possible Impact on Prices

Biosimilars, a category of biologic (medicine derived from a living organism), require approval, at least in the U.S. by the…

Deep Dive Episode 263 – Food Safety: When Regulatory Jurisdictional Battles and Public Safety Collide

Food is a necessity for life. It should therefore surprise few that the federal government regulates the production and processing of food before it reaches our dinner tables.

Explainer Episode 52 – What Came Next: FDA’s Response to the Reagan-Udall Foundation’s December Reports on FDA’s Tobacco and Human Foods Program

In late February 2023, the FDA released its responses to the December 2022 Regan-Udall Foundation reports on the FDA’s Human Foods and Tobacco programs.

Explainer Episode 51 – Beyond Medicaid? Potential Paths Forward to Better Healthcare

In this podcast featuring Tom Miller, he lays out a brief summary of how we got to where we are with regards to Medicaid.

Deep Dive Episode 253 – Litigation Update: AHM v. FDA: Challenging the FDA on “Chemical Abortion Drugs”

In November 2022, the Alliance Defending Freedom (ADF) filed a federal lawsuit against the FDA on behalf of the AHM and others, challenging the FDA’s 2000 decision to legalize mifepristone and misoprostol, two drugs often used in conjunction as chemical abortifacients.

Explainer Episode 48 – The FDA & the Practice of Medicine: Possible Regulation of Off-Label Prescriptions

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law. This omnibus law is over 4,100 pages, and, like many omnibus bills, affects a broad range of issues.

Explainer Episode 46 – The Reagan-Udall Foundation’s December Reports on FDA’s Tobacco and Human Foods Programs: What the Reports Mean and What Comes Next

In this podcast, Jeff Stier breaks down some of what the reports say, and what the next steps for both the FDA and Congress may be.

Explainer Episode 45 – Telehealth & COVID-19

Health policy experts join us to discuss telehealth regulation – what it is, what happened to it during COVID-19, and what the opportunities and barriers are for future telehealth innovation.

Explainer Episode 41 – Government Obstacles to Over The Counter Medicines

In this podcast, health policy experts discuss the role that the federal government plays in requiring prescriptions for medicines.

Explainer Episode 39 – Tax Exclusions for Employer-Sponsored Health Insurance

In this episode, Michael F. Cannon explains why he views the federal income tax exclusion of employer-sponsored health insurance as an “accident of history.”

Explainer Episode 35 – Why Was the CDC’s Travel Mask Mandate Struck Down?

Health law and policy expert Joel Zinberg joined the podcast to break down Judge Kathryn Kimball Mizelle’s ruling vacating the CDC’s public transit mask mandate.

Deep Dive Episode 215 – Sundown for the SUNSET Rule?

An expert panel joined us to discuss HHS’s SUNSET rule, the effort to repeal it, and possible future HHS actions.

Deep Dive Episode 209 – Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?

Michael Cannon, Joshua Sharfstein, and moderator Dan Troy debated who should decide which drugs require prescriptions.

Deep Dive Episode 208 – A Debate on COVID-19 Vaccine Mandates

Lawrence Gostin, David Hyman, and Jenin Younes joined the Federalist Society’s Georgetown Law Student Chapter to debate COVID-19 vaccine mandates.

Explainer Episode 31 – The Regulation of E-Cigarettes and Vapes

Health policy expert Jeff Stier joins the podcast to discuss all things concerning the regulation of e-cigarettes and vapes.

Deep Dive Episode 201 – Fixing Food: An FDA Insider Unravels the Myths and the Solutions

Professor David Hyman interviews Dr. Richard Williams about Dr. Williams’ new book, “Fixing Food: An FDA Insider Unravels the Myths and Solutions.”

Explainer Episode 30 – An Update on Telemedicine Laws and Regulations

Experts explore the rationales behind telemedicine regulations and examine how reforms and lawsuits might transform how patients receive care.

Deep Dive Episode 194 – Examining the CDC’s Eviction Moratorium

Top experts dive deep into the legal issues surrounding the CDC’s eviction moratorium and the relief sought by both landlords and renters.

Deep Dive Episode 173 – The State of Healthcare Policy: from COVID-19 to Medicare for All

Professors Gregg Bloche, Larry Gostin, David Hyman, and Timothy Westmoreland discuss the current state of healthcare policy in the United States.

Deep Dive Episode 156 – Incentivizing Drug Development: Patents or Prizes?

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.

Explainer Episode 20 – COVID-19 Vaccine Approval and Distribution

Joel Zinberg joins the podcast to discuss a range of COVID-19 vaccine questions.

Deep Dive Episode 148 – Civil Liberties and COVID-19 Shelter in Place Orders

On November 19, 2020, RTP co-hosted an online event featuring Professor Julia Mahoney and J. Gregory Grisham.

Deep Dive Episode 136 – It Can Be Done Live: The Future of Our Health

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.

Deep Dive Episode 133 – Medicare for All? A National Single-Payer v. Private Payer Insurance Debate

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.

Deep Dive Episode 102 – COVID-19 and Regulatory Reform Efforts at HHS

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.

Deep Dive Episode 99 – Promoting a More Adaptable Physician Pipeline

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.

Deep Dive Episode 98 – Regulatory Reforms and the COVID Pandemic

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.

Deep Dive Episode 97 – Certificate of Need Laws and Healthcare Access

Explainer Episode 12 – A Recipe for A Better World: Nine Parts Innovation, One Part Regulation

In this episode, Jeff Stier draws on the experience of Impossible Burger to argue for light touch regulation on harm-reducing technologies.

Deep Dive Episode 83 – Medicare for All

In this episode, Roger Klein and Adam Broad debate the merits of the increasingly prominent “Medicare for All” proposal for healthcare. The discussion is moderated by Courtney Hughes.

Deep Dive Episode 26 – Is the FDA’s Rule on Cigars & Vaping Products Constitutional?

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.

Deep Dive Episode 17 – Off-Label Promotion and Free Speech in Medicine

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.

Supreme Court to Decide Whether EMTALA Preempts State Abortion Laws: Idaho v. U.S. and Moyle v. U.S.

Abortion is before the Supreme Court once again. This month, the Court granted certiorari in consolidated cases Moyle v. United States and Idaho v. United States.

Implementation of Reagan-Udall’s Recommended Reforms for the Center for Tobacco Products Reforms, A Six Month Status Report

Jeff Stier

About six months ago, the Reagan-Udall Foundation sent the Food and Drug Administration its Operational Evaluation of FDA’s Tobacco Program. this is a report that the FDA itself requested in July of 2022. How is the Center for Tobacco Products (CTP) implementing the recommendations of the report to date?

HHS Proposes Rule Modifying Healthcare Conscience Regulations

Rachel Morrison

On January 5, 2023, the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) titled “Safeguarding the Rights of Conscience as Protected by Federal Statutes.” The 11-page NPRM is open for public comment for 60 days until Monday, March 6.

The Real World Costs of Heavy-Handed Chemical Regulation

Jeff Stier

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.

A Recipe for A Better World; Nine Parts Innovation, One Part Regulation

Jeff Stier

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.

Fixing How FDA Regulates Diagnostic Lab Tests

Roger D. Klein

It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing