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 years¹.

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 States². 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 flat³. 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 companies⁴. 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. The Life Extension Foundation endorses 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. This issue of Life Extension magazine reveals how the FDA knowingly approved a dangerous drug to be sold to healthy women.

1. Advancing Medical Innovation: Health, Safety and the Role of Government in the 21st Century.
   The Progress and Freedom Foundation, 1996.
2. The Journal of the American Medical Association
   (JAMA), April 15, 1998.
3. Science (1998:May).
4. University of California at San Diego study (1997).

William Faloon
Vice President
Life Extension Foundation