Consumers Against High Drug Prices
Exposing The FDA's Regulatory Quagmire
CoQ10 Wars
Assembly Line Medicine
Collapsing Within Itself
Intolerable Delays!
"Unsustainable" Cancer Drug Prices
How Government Treated Those For Whom We Now Celebrate Holidays
Horrific Conditions Inside Drug Factories
When "Rules" Are Broken
Federal Death Panels
Science by Ambush
The Looming Doctor Shortage
Former FDA Commissioner Admits Risk of Bureaucratic Delay
FDA Says Walnuts Are Illegal Drugs
The FDA's Most Heinous Drug Approval
No Real Healthcare Cost Crisis
FDA Delay of One Drug Causes 82,000 Lost Life-Years
Deadly FDA Neglect
How Much More FDA Abuse Can Americans Tolerate?
Drug Company Pleads Guilty to Health Fraud
Why American Healthcare is Headed for Collapse
The Generic Drug Rip-off
Ending the Atrocities
Millions of Needless Deaths
Would You Tolerate This Abuse?
The FDA Indicts Itself
The FDA's Cruel Hoax
Fish Oil Now Available by Prescription!
FDA Threatens to Raid Cherry Orchards
Inside the FDA's Brain
FDA Fails to Protect Domestic Drug Supply
FDA Permits New Fish Oil Health Claim
FDA Approves Deadly Drugs, Delays Lifesaving Therapies
The $50.00 Toll Bridge
Dangerous Medicine
Cardiologists Overlook Lifesaving Discovery
What You Don’t Know About Blood Sugar
Jerry Falwell Attacks Life Extension Foundation
Life Extension Achieves "Impossible" Victory in the U.S. House of Representatives
Fighting the FDA
Patient Advocates Sue FDA Over Drug Access
FDA's Lethal Impediment
Don't Blame the Doctors
One Man's Ten-Year Ordeal With Prostate Cancer
A New Day At FDA?
The FDA Versus the American Consumer
Supreme Court Roundup
The Lethal Information Gap
Consumer Rape
Dying From Deficiency
Are Offshore Drugs Dangerous?
Drugs the FDA Says You Can't Have
Does Cholesterol Cause Artery Disease?
What's Wrong with the FDA
FDA Suffers Second Massive Legal Defeat in Pearson v. Shalala
FDA Loses Case Against Compounding Pharmacies on First Amendment Grounds
Ending The Cancer Bureaucracy
Victory in the House and Senate
Life Extension Wins in the House and Senate
Congress Recognizes The Prescription Drug Problem
Americans are getting Healthier... But the FDA Remains a Major Impediment
Are We to Become Serfs of the Drug Monopoly?
A Glorious Victory Over FDA Tyranny
The Great American Rip-Off
The Plague Of FDA Regulation
Health Costs to Double Is there a free-market solution?
The FDA versus Folic Acid
They Want You Brain Dead
Life Extension vs. the FDA a Hollow Victory: Why the Agency's Approval of Ribavirin is Inadequate

The Plague Of FDA Regulation

Few people realize how long it takes before a scientific breakthrough turns into a life-saving therapy. The bureaucratic process is so burdensome that the total time from discovery to market approval has more than doubled since 1964, from 6.5 years to 14.8 years[1].

FDA Regulation One might think that this delay is at least providing Americans with safe medicines. The facts tell otherwise. This month's issue exposes a drug-approval system riddled with incompetence and corruption that results in the death of over 125,000 Americans every year from drugs the FDA says are safe. The current system provides a protected market for pharmaceutical giants who can afford to pay top dollar to get their drugs legalized in this country. As in any market that is artificially protected, innovation is stifled and the consumer pays a grossly inflated price for the final product.

The United States government officially endorses unfettered competition in the marketplace, yet when it comes to medicines, there is no free market. The revolving door between the FDA and multi-national drug companies creates a system that excludes outsiders, and virtually ensures that Americans only have access to drugs guaranteed to make billions for large companies. The recent trend is for companies to develop "life-enhancing" drugs, such as Viagra, at the expense of life-saving drugs that may return less profit. The FDA takes extraordinary steps to keep out foreign competition, even if the offshore drug is safer, cheaper, and more effective than its American counterpart. The net result is that Americans pay the highest prices in the world for pharmaceuticals. At the same time, we suffer the highest rate of drug-induced adverse reactions, in as much as deaths from prescription drugs are the fifth or sixth leading cause of death in the United States[2]. Inflated prices for bad products reflect a system that is corrupt and must be changed if Americans are to live healthier and longer.

Drug manufacturers criticize the FDA for the delay and high cost of getting new drugs through the system. One statistic drug companies point to is that from 1977 to 1996, they increased spending on new pharmaceutical compounds 15-fold, yet FDA approval of new drugs remained relatively flat[3]. Additional problems cited by the drug industry include turnover of FDA personnel, limitations of drug reviewers' technical knowledge and communication problems between the FDA and the drug companies[4]. Yet, as readers of this issue are about to learn, large pharmaceutical companies are by no means innocent victims of FDA red tape.

All of this points to a bureaucratic quagmire that enables large drug companies to dominate the market, making it far too expensive for smaller companies to compete. We endorse a deregulated market, where economic success is predicated on a company developing effective products at a fair price. In a free market, companies that make unsafe or ineffective products would be driven out of business, and Americans would soon gain access to more advanced medicines to prevent and treat the degenerative diseases of aging.

The problem is that virtually no one understands the decision making process at the FDA. That's about to change.

1. Advancing Medical Innovation: Health, Safety and the Role of Government in the 21st Century. The Progress and Freedom Foundation, 1996.

3. Science (1998:May).

4. University of California at San Diego study (1997).