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The FDA's Caution Is Hazardous to Our Health

From the Panel

  • For: Dr. Scott Gottlieb

  • A Compounding Fracture at the FDA
    Scott Gottlieb and Sheldon Bradshaw, Wall Street Journal, November 13, 2012The FDA has failed for decades to clearly establish enforcement policies related to pharmacy compounders because the agency doesn't want to concede that it was never supposed to have jurisdiction over the legitimate, local practices of pharmacy and medicine.
  • Changing the FDA's Culture
    Scott Gottlieb, National Affairs, Summer, 2012The FDA’s excessive desire for certainty is primarily driven not by fear of unforeseen dangerous side effects caused by drugs under review, but by a deepening mistrust of the doctors who prescribe such medicines and the companies that market them.
  • Compounding a Crisis
    Scott Gottlieb, The American, October 16, 2012FDA regulation of the development and manufacture of drugs is a costly endeavor. It adds to the price of drugs. Politicians cannot simultaneously support increased regulation of drugs and then undermine safety goals when the same rules drive out cost competition, leaving only the more expensive versions available.
  • The FDA Wants to Regulate Your Cells
    Scott Gottlieb and Coleen Klasmeier, Wall Street Journal, August 7, 2012A recent decision by a federal trial court gave the Food and Drug Administration the latitude that the agency has long sought to regulate our cells as drugs. It could put the brakes on one of the most promising areas of medical research.
  • There’s a Medical App for That—Or Not
    Scott Gottlieb and J.D. Kleinke, Wall Street Journal, May 29, 2012The FDA wants to regulate software used to support the decisions made by patients and health-care providers in the same way it regulates the software embedded in medical hardware such as X-ray machines and infusion pumps.
  • Solving the Growing Drug Shortages
    Scott Gottlieb, Wall Street Journal, November 4, 2011Until government price controls are lifted, the makers of generics will be unable to cover their production costs.
  • How the FDA Could Cost You Your Life
    Scott Gottlieb, Wall Street Journal, October 3, 2011An aortic valve approved in Europe four years ago will soon be approved in the U.S. Meanwhile, thousands who may have benefited from the device have died.
  • The FDA Should Not Mandate Comparative-Effectiveness Trials
    Scott Gottlieb, AEI Health Policy Outlook, June 15, 2011We need to develop better models for doing clinical trials that are specifically geared toward generating comparative data.
  • Feds to Biotech Firms: Shut Up
    Scott Gottlieb, Wall Street Journal, June 6, 2011Medicine will suffer if Washington controls the flow of scientific information.
  • The FDA Is Evading the Law
    Scott Gottlieb, Wall Street Journal, December 23, 2010Europeans are approving important new drugs more rapidly than we are.

  • For: Peter Huber

  • The FDA and Methuselah
    Peter Huber, Forbes, April 12, 2011Cellular intervention to slow aging is a science in its infancy. Will regulators keep it there forever?
  • Anthraxing New York
    Peter Huber, City Journal, Autumn 2009Government-controlled vaccine development has left us scarily vulnerable.
  • Curing Diversity
    Peter Huber, City Journal, Autumn 2008The new medicine shows that we’re biochemically separate and unequal—and regulators are starting to catch on.
  • Conflicted Doctors
    Peter Huber, Forbes, March 13, 2008Brilliant doctors often work closely with big drug companies, and they seem to like their corporate partners just fine.
  • Cherry Garcia and the End of Socialized Medicine
    Peter W. Huber, City Journal, Autumn 2007The new pharmacopoeia offers people too much knowledge and control for one-size-fits-all health care to cope with.
  • The Patient’s Right to Know
    Peter Huber, Forbes, July 24, 2006Diagnostic technology is on a collision course with the FDA.
  • Of Pills and Profits: In Defense of Big Pharma
    Peter Huber, Commentary, July 1, 2006Big drug companies shun some drugs and embrace others because, collectively, the FDA, doctors, patients, insurers, and juries push costs higher, and prices lower, on some categories of drugs and not on others, to the point where some make economic sense and some do not.
  • Biotechnology and the Regulation HYDRA
    Peter Huber, MIT Technology Review, November/December 1987No regulatory system will ever be "right" about every issue clouded in scientific doubt. But an industry should be able to ask for a process that will be reasonably quick and definitive.
  • Against: Dr. Jerry Avorn

  • Conversation with a Harvard Expert
    Interview with Dr. Jerry Avorn, September 2011, Harvard Health LetterA critic of the pharmaceutical industry, Avorn believes companies are now somewhat more cautious, primarily because the FDA has become more vigilant.
  • Will Health-Care Reform Save Medical Innovation? An Interview with Dr. Jerry Avorn
    Ezra Klein, Washington Post, August 3, 2009Innovation in the pharmaceutical industry is not coming from inside large companies, but from the purchase of biotech start-ups.
  • The Sting of Ignorance
    Jerry Avorn, New York Times, September 16, 2006Even when good clinical trial data on a regimen or medicine exist, no coherent system ensures that the message gets out to doctors and patients. As a result, many treatment choices are driven by habit, old information or glitzy promotional campaigns.
  • Letter to House Committee on Government Reform
    Jerry Avorn, May 25, 2006A letter to Congressman Henry Waxman expressing concerns regarding FDA enforcement.
  • FDA Standards—Good Enough for Government Work?
    Jerry Avorn, New England Journal of Medicine, September 8, 2005There is one area of biomedicine in which the government allows — even defends — a minimal standard that would be unacceptable anywhere else in research. It is the set of evidentiary requirements maintained by the FDA for the approval of new drugs.
  • Interview with Dr. Jerry Avorn
    Rachel Gotbaum, New England Journal of Medicine, September 8, 2005Interview with Dr. Jerry Avorn on the FDA’s standards for approving new drugs.
  • An Interview with Jerry Avorn
    Amos Esty, American Scientist, December 2004There are a few areas in which the government is indispensable. First is its public health role in making sure that all drugs on the market are safe and effective. The second crucial role for government is to make sure that every citizen has the capacity to pay for needed medical care, and that includes drugs.
  • FDA Drug Screening Measures Under Intense Scrutiny
    PBS NewsHour , November 23, 2004Report on the state of the FDA's drug testing policies.
  • Excerpt from Powerful Medicines
    Jerry Avorn, August 2004, Random HouseVigilance disappears when it comes to requiring and analyzing the data that we need to be able to learn about the safety of the drugs once they're in widespread use.

  • Against: David Challoner

  • Public Health Effectiveness of the FDA 510(k) Clearance Process at 35 Years
    David Challoner, Committee Chair, Institute of Medicine, July 29, 2011The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.
  • Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years
    David R. Challoner, Written Statement before the Committee on Health, Education, Labor, and Pensions, US Senate, November 15, 2011Testimony for the record based on the IOM’s report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 years.
  • The IOM Report on the FDA’s 510(k) Process
    Interview with David Challoner, CurrentMedicine.TV, August 11, 2011The next steps and whether the FDA, pressured by congress and the White House to be pro-medical devices and keep the 510(k) process, will listen to the report or ignore it.


  • FOR

  • Theory, Evidence and Examples of FDA Harm
    Daniel Klein and Alexander Tabarrok, FDAReview.org, The Independent InstituteThree bodies of evidence suggest that the FDA kills and harms, on net.
  • Big Ideas
    Gary Becker, Milken Institute, 2004Elimination of the efficacy requirement—and requiring only a safety standard—would lower costs and raise the number of therapeutic compounds available.
  • Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials
    Avik Roy, Manhattan Institute, April 2012Though 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.
  • End the FDA Drug Monopoly: Let Patients Choose Their Medicines
    Doug Bandow, Cato Institute, June 11, 2012Who 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.
  • Cost of Caution: The Impact on Patients of Delayed Drug Approvals
    Tomas Philipson and Eric Sun, Project FDA Report, Manhattan Institute, June 2010This 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.
  • FDA Approvals Are a Matter of Life and Death
    Andrew von Eschenbach, Wall Street Journal, June 17, 2012Today the medical-device industry flourishes overseas, even as it struggles under unnecessary regulatory burdens in the U.S.
  • Some Remarks About Medical Devices
    Daniel Klein and Alexander Tabarrok, FDAReview.org, The Independent InstituteAlthough 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.
  • Medical Treatment, Out of Reach
    Andrew Pollack, New York Times, February 9, 2011Medical 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.
  • FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies
    Josh Makower, Aabed Meer and Lyn Denend, November 2010This 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.

  • FDA: This Agency Can Be Dangerous
    Marcia Angell, New York Review of Books, September 30, 2010There 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.
  • Are Prescription Drugs Safe? Not Necessarily
    ConsumerReports, last updated November 2009The U.S. system for identifying drug risks before approval is flawed—and the one for spotting them afterward is even worse.
  • Ethical and Scientific Issues in Studying the Safety of Approved Drugs
    Institute of Medicine, May 1, 2012The 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.
  • Medical Device Recalls and the FDA Approval Process
    Diana Zuckerman, Paul Brown and Steven Nissen, Archives of Internal Medicine, June 13, 2011Most 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.
  • Medical Devices That Can Kill
    Shannon Brownlee and Jeanne Lenzer, Reader’s Digest, August 23, 2010How did we get to a point where we can't trust the equipment doctors use for—and in—our bodies?
  • A Call to Prevent Unsafe, High-Risk Medical Devices From Reaching Patients
    Leland Kim, UCSF, January 28, 2013A 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.
  • FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process
    U.S. Government Accountability Office, January 2009GAO 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.
  • Letter to Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA
    Edward Markey and Jeff Merkley, August 15, 2012Congressman 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.
  • FDA Medical Device Approval Based on Politics, Not Science
    Union of Concerned Scientists, last revised November 10, 2009Food 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.