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The FDA'S Caution Is Hazardous To Our Health

The BriefGet Up To Speed

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?


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

Wednesday, December 31, 1969
Daniel Klein and Alexander Tabarrok

Elimination of the efficacy requirement—and requiring only a safety standard—would lower costs and raise the number of therapeutic compounds available.

Tuesday, March 1, 2016
Gary Becker

Though the United States urgently needs new treatments for common illnesses such as heart disease, stroke, and diabetes, the nation’s system for drug approval discourages innovation and investment, especially for our most pressing public health challenges.

Sunday, April 1, 2012
Avik Roy

Who should decide what drugs to use? Patients. They need advice, not diktats. Congress should strip the FDA of its regulatory monopoly over pharmaceuticals and medical devices.

Monday, June 11, 2012
Doug Bandow

This study argues that the cost of protracted regulatory drug review to patients who stand to benefit is not only considerable, in terms of the monetary value to patients of earlier treatment, but exceeds the costs to prescription-drug developers.

Tuesday, June 1, 2010
Tomas Philipson and Eric Sun

Today the medical-device industry flourishes overseas, even as it struggles under unnecessary regulatory burdens in the U.S.

Sunday, June 17, 2012
Andrew von Eschenbach

Although the regulation of devices has not been as well studied as the regulation of drugs, it is clear that FDA control of such devices has led to similar costs, especially device lag and device loss.

Wednesday, December 31, 1969
Daniel Klein and Alexander Tabarrok

Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the U.S. and overseas is being jeopardized by a heightened regulatory scrutiny.

Wednesday, February 9, 2011
Andrew Pollack

This survey, funded in party by the Medical Device Manufacturers Association, found that unpredictable, inefficient, and expensive regulatory processes put the U.S. at risk of losing its global leadership position in medtech innovation.

Monday, November 1, 2010
Josh Makower

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.

Thursday, September 30, 2010
Marcia Angell

The U.S. system for identifying drug risks before approval is flawed—and the one for spotting them afterward is even worse.

Sunday, November 1, 2009

The FDA’s current approach to drug oversight in the postmarketing setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over a drug’s life cycle.

Tuesday, May 1, 2012
Institute of Medicine

Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk they were exempt from review.

Monday, June 13, 2011
Diana Zuckerman

How did we get to a point where we can't trust the equipment doctors use for—and in—our bodies?

Monday, August 23, 2010
Shannon Brownlee and Jeanne Lenzer

A UCSF-led commentary is calling attention to a little-known regulatory loophole that allows unsafe and untested medical devices to reach the marketplace and harm patients.

Monday, January 28, 2013
Leland Kim

GAO recommended that all class III devices—implantable, life sustaining, posing significant risk to the patient—go through the more stringent Premarket Approval (PMA) process and not the Premarket Notification 510(k) process.

Thursday, January 1, 2009
U.S. Government Accountability Office

Congressman Markey and Senator Merkley’s request that the FDA overhaul and streamline its Recalls and 510(k) Premarket Notification databases, pointing out a flaw in the 510(k) process.

Wednesday, August 15, 2012
Edward Markey and Jeff Merkley

Food and Drug Administration (FDA) officials bowed to political lobbying and circumvented normal process to approve Menaflex, a knee implant made of cow collagen, over staff scientists' objections. Other FDA scientists have called public attention to systemic political interference in the approval of medical devices.

Tuesday, November 10, 2009
Union of Concerned Scientists

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

Wednesday, December 31, 1969

The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness. It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs.

Wednesday, December 31, 1969

The FDA has three approaches to making drugs that treat serious diseases available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track.

Wednesday, December 31, 1969

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

Wednesday, December 31, 1969

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval.

Wednesday, December 31, 1969

An overview of FDA regulation of medical devices, which includes two paths that manufacturers can use to bring devices to market—premarket approval (PMA) and 510(k) notification.

Monday, June 25, 2012
Judith Johnson

The FDA’s slow and secretive response to drug approvals based on fraudulent studies by Cetero Research was not an anomaly.

Wednesday, April 17, 2013
Rob Garver and Charles Seife

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

Wednesday, October 10, 2012
David Maris

Merck yanked Vioxx on Sept. 30 because a new study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo. But the new Vioxx study was not the first to raise concerns about heart attack and stroke risk.

Tuesday, October 12, 2004
Rita Rubin

Daniel Carpenter discusses the implications of the FDA advisory panel decision to uphold an earlier agency decision to yank the breast cancer indication for Avastin.

Thursday, June 30, 2011
Ed Silverman

A year before recalling an artificial hip, an executive at Johnson & Johnson reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in “significant” numbers, requiring repeat surgeries for patients.

Tuesday, February 21, 2012
Barry Meier

The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.

Tuesday, December 4, 2012

Rethinking the streamlined approval process for radiotherapy equipment.

Thursday, April 8, 2010
Walt Bogdanich

A new study found that for new oncology drugs between 2003 and 2010, the median time for FDA approval was six months, compared to nearly as long for the EMA.

Thursday, June 16, 2011
Chris Fleming

A host of interrelated factors complicate the FDA’s ability to determine the risk/benefit profile of medical devices. But does the FDA do any worse than comparable agencies abroad?

Saturday, September 1, 2012
Barbara Fant

A review of the data suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the U.S. as it does in the four largest European markets (Germany, France, Italy, and Britain) — largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.

Thursday, August 9, 2012
Saptarshi Basu and John C. Hassenplug

FDA often hears claims that the U.S. approves new drugs less quickly than other regulatory agencies, particularly the European Medicines Agency. This is not true; in many cases, FDA gets a drug on the market faster than does Europe.

Wednesday, December 31, 1969

One year on from a breast implant scandal that shook confidence in Europe’s light-touch system for regulating medical devices, lawmakers and manufacturers are at loggerheads on ways to protect patients from shoddy products.

Wednesday, February 20, 2013
Ben Hirschler
Related Articles

In 2011 the FDA released a first draft of guidelines that require mobile apps developers making medical claims to apply for FDA approval for those applications, the same way that new medical devices must be proven safe and effective before they can be sold.

Wednesday, June 6, 2012
Jenny Gold