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The FDA'S Caution Is Hazardous To Our Health

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  • David Challoner: FDA Device Approval Reduces Mortality

    Clip: Using a grim illustration of what happens when medical devices are not properly regulated Dr. David Challoner of the University of Florida explains why the FDA plays an important role in patient safety.

  • Peter Huber: Onerous FDA Bureaucracy Holds Back Science

    Clip: Manhattan Institute senior fellow Peter Huber describes the FDA as being shortsighted when it comes to using new science in drug approval especially for targeted personalized medicines.

  • Drug Safety and Approval Is About Trusting Government

    Clip: Dr. Scott Gottlieb of the American Enterprise Institute and Dr. Jerry Avorn of Harvard Medical School debate the role the government plays in maintaining public safety and delivering effective medicine.

  • Is the FDA Keeping Good Drugs off the Market?

    Clip: Dr. Jerry Avorn argues against the motion "The FDA's Caution Is Hazardous to Our Health."

  • John Donvan on the FDA

    Clip: Moderator John Donvan describes the purpose of the FDA and introduces the motion "The FDA's Caution Is Hazardous to Our Health."

  • Will Doctors Harm Patients with Fast-tracked Drugs?

    Clip: Peter Huber argues for the motion "The FDA's Caution Is Hazardous to Our Health."

Debate Details

The Food and Drug Administration, the oldest comprehensive consumer protection agency in the U.S. federal government, is charged with protecting the public health.  Under this mandate, it regulates drugs and medical devices for their safety and effectiveness.  But is it a failing mandate?  It’s long been argued that the FDA’s long and costly approval processes stifle innovation and keep life-changing treatments from the market.  But the question remains: when it comes to public health, is it ever okay to sacrifice safety for speed?

The Debaters

For the motion

Dr. Scott Gottlieb

Practicing Physician & Former Deputy Commissioner, FDA

Scott Gottlieb, M.D., is a practicing physician and a resident fellow at the American Enterprise Institute. From 2005 to 2007, he served as the FDA... Read More

Peter Huber

Senior Fellow, Manhattan Institute and Author

Peter Huber is a senior fellow at the Manhattan Institute writing on the issues of drug development, energy, technology, and the law. Before joining... Read More

Against the motion

Dr. Jerry Avorn

Professor of Medicine, Harvard Medical School

Jerry Avorn, M.D., is a professor of Medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in... Read More

Dr. David Challoner

VP for Health Affairs Emeritus, University of Florida

David R. Challoner, M.D. is vice president emeritus for Health Affairs of the University of Florida.  Dr. Challoner has held leadership and health... Read More

Where Do You Stand?

For The Motion
  • Costly and lengthy approval processes for drugs and medical devices discourages investment and stifles innovation.
  • The FDA wants a guarantee of benefits, not proof of risks, which means extended testing and clinical trials that keep potentially beneficial treatments from patients.
  • Drugs are often rejected based on a small risk, despite many proven benefits.
  • Regulations have been too broad, leading to unnecessary facility closures for upgrades and checks that have created dangerous drug shortages.
Against The Motion
  • Accelerated approval for drugs, while making potentially beneficial drugs available quickly to patients, also means that they are available for widespread use before their safety can be determined.
  • The 510(k) approval process, which fast-tracks the approval of medical devices that are _substantially equivalent_ to an existing device, releases unsafe devices into the market.
  • The FDA does very little monitoring of safety and effectiveness once drugs and devices are approved and used by the public.
  • To those that argue that the approval process is too lengthy, in many cases, the FDA gets a drug on the market faster than Europe.

Results

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Pre-Debate
Post-Debate

The Research

The Research

What Does the FDA Regulate?

December 31, 1969

The FDA regulates: foods; dietary supplements; human drugs; vaccines, blood products and other biologics; medical devices; electronic products; cosmetics; veterinary products; and tobacco products.

FDA: This Agency Can Be Dangerous

Marcia Angell
September 30, 2010

There is growing evidence that the Center for Drug Evaluation and Research, the part of the agency that regulates prescription drugs, has become the servant of the industry it regulates. This has resulted in the sale of drugs of uncertain benefits, some with serious side effects, and in the agency’s failure to respond promptly to evidence that a drug is dangerous.

Theory, Evidence and Examples of FDA Harm

Daniel Klein and Alexander Tabarrok
December 31, 1969

Three bodies of evidence suggest that the FDA kills and harms, on net.

FORAGAINSTBackgroundDrugs
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