Segments in this Video

Intro: FDA Debate (03:40)


Intelligence Squared U.S. Debate Forum Chairman Robert Rosenkranz and moderator John Donvan discuss controversy around the drug approval process and welcome debaters to the stage.

FDA Debate "Housekeeping" (05:54)

Donvan states the motion, explains the debate format, introduces panelists, and instructs audience members to vote.

For the Motion: Dr. Scott Gottlieb (07:03)

American Enterprise Institute fellow Dr. Scott Gottlieb argues that FDA statistical trials are outdated and cites a case where Hunter's Syndrome patients suffered due to review inefficiency.

Against the Motion: Dr. Jerry Avorn (06:40)

Harvard Medical School professor Dr. Jerry Avorn argues that the FDA has relatively short drug review times, and that its public safety role should be upheld.

For the Motion: Peter Hubert (07:49)

Manhattan Institute fellow and author Peter Huber argues that the FDA's one size fits all approach is ineffective for disease complexity, and explains the advantages of the accelerated approval rule.

Against the Motion: Dr. David Challoner (07:49)

University of Florida VP for Health Affairs Emeritus Dr. David Challoner cites FDA approved medical devices causing patient harm and explains loopholes causing safety flaws in the approval process.

Understanding FDA Drug Trials (04:27)

Scott Gottlieb (for) explains how the drug development process works using three phases of clinical trials and increasing numbers of subjects.

FDA Fast Track (03:57)

Jerry Avorn (against) argues that accelerating approval for all drugs would stretch FDA resources; Peter Hubert (for) argues that outdated protocols are inhibiting precision medicine.

Accelerated Approval and Public Safety (02:06)

David Challoner (against) argues that the FDA's fast track process requires post-market studies; Peter Huber (for) argues that Bayesian trials allow for constant refinement.

FDA Uncertainty (03:10)

Jerry Avorn (against) cites a fast tracked TB drug increasing mortality rates. Scott Gottlieb (for) argues that long term clinical trials using statistics are inefficient.

FDA's Role (04:03)

David Challoner (against) argues that drug industry salaried staff have a conflict of interest; Scott Gottlieb (for) cites medical devices approved in Europe that the FDA won't clear.

FDA Approval Rates (03:10)

Jerry Avorn (against) argues that clinical trials during drug development are necessary for public safety.

Accelerated Drug Approval Ethics (04:57)

Jerry Avorn (against) argues that untested drugs shouldn't be given to terminally ill patients. Panelists debate whether the FDA supports using molecular medicine to develop custom treatments.

FDA Conflict of Interest (02:21)

Jerry Avorn (against) argues that health regulation is necessary for public safety; Scott Gottlieb (for) argues for reducing evidence requirements and trusting doctor judgment.

QA: Unsafe Drug Approval (03:44)

Peter Huber (for) argues that the FDA and medical community should learn from past mistakes and develop safety biomarkers.

QA: Public vs. Individual Health (03:09)

Jerry Avorn (against) argues that FDA regulation is necessary for society's benefit. Scott Gottlieb (for) argues that companies aren't developing drugs due to inefficient clinical trials.

QA: Side Effect Uncertainty (03:23)

Scott Gottlieb (for) argues that neither fast tracked nor clinically trialed FDA drugs can guarantee 100% patient safety.

QA: Prescribing Drug Cocktails (01:53)

Peter Huber (for) argues that oncology requires doctors to develop individual molecular treatments—a practice the FDA allows.

QA: Bayesian Statistical Model (02:27)

Peter Huber (for) argues that medical technology advances are allowing doctors to customize drugs; Jerry Avorn (against) argues that randomized clinical trials are best for evaluating uncertainty.

QA: Drug Industry Financing FDA (03:02)

Scott Gottlieb (for) argues that user fees aren't causing a regulatory conflict of interest; David Challoner (against) is concerned that 50% of commissioner's salary is funded by the industry.

QA: Promoting Drug Development (01:32)

Jerry Avorn (against) says the FDA allows surrogate measures to expedite the approval process in some cases.

QA: FDA Precautionary Principle (04:46)

Jerry Avorn (against) argues for upholding scientifically rigorous testing; Scott Gottlieb (for) argues for taking more risks with drug development and approval.

Closing Statement Against: Jerry Avorn (02:29)

Avorn uses the thalidomide case to argue that drug companies should be regulated by government.

Closing Statement For: Scott Gottlieb (01:42)

Gottlieb cites Hunter's Disease patients whose symptoms worsened after taking placebos as an argument for reforming the FDA's clinical trial model and regulatory approach.

Closing Statement Against: David Challoner (01:56)

Challoner argues that the industry hides drug failure data from the FDA, and the FDA is therefore responsible for maintaining public health safety.

Closing Statement For: Peter Huber (02:30)

Huber argues that the FDA's failure to incorporate molecular and customized medicine is hurting public health.

Audience Vote Results (01:42)

Predebate For: 24% - Against: 32% - Undecided: 44% Post-debate For: 53% - Against: 38% - Undecided: 9%

Credits: The FDA’s Caution Is Hazardous to Our Health: A Debate (00:44)

Credits: The FDA’s Caution Is Hazardous to Our Health: A Debate

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The FDA’s Caution Is Hazardous to Our Health: A Debate

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Established in 1906, the U.S. Food and Drug Administration (FDA) is charged with protecting public health. Under this mandate, the federal agency regulates drugs and medical devices to ensure their safety and effectiveness. But is the FDA failing this mandate? Some argue that the FDA’s long and costly approval process stifles innovation and keeps life-changing treatments from the market, but defenders contend that the process is essential to ensure safety and protect public health. Is the FDA too cautious in approving new drugs and medical devices? Is it ever appropriate to sacrifice safety for speed?

Length: 103 minutes

Item#: BVL58349

ISBN: 978-0-81609-928-3

Copyright date: ©2013

Closed Captioned

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