The Food and Drug Administration (FDA) has become a dangerous roadblock to new drugs and medical devices entering the marketplace.

One reason is the expansion of the FDA's role from ensuring the safety of drugs to judging their effectiveness (the 1962 Kefauver-Harris drug amendments). In addition, in 1976 Congress gave the FDA wide authority over medical devices, and required manufacturers to register with the FDA and follow its quality control procedures.

After passage of the Kefauver-Harris amendments, the time it took for a medical product to be approved for use in the U.S. began to lag behind other countries. For example, a study of 46 new drugs approved by the FDA between 1985 and 1986 found that 72 percent were available an average 5.5 years later in the U.S. than in foreign markets.

Although the number of FDA employees increased by 15 percent between 1990 and 1994, the number of applications processed by the FDA has fallen.

• In 1991, the applications for 30 new molecular drugs approved by the FDA took an average of 30 months to process.

• Although the average approval time decreased to approximately 20 months by 1994, the number of applications approved fell to 22, the fewest since 1988.

• The average review time for abbreviated new drug applications skyrocketed from 23 months in 1990 to 38 months in 1993.

• Furthermore, the average time to approve routine medical device applications in 1995 is expected to be 138 days, although the law requires the FDA to process the applications within 90 days.

Requests to approve new medical devices dropped from 79 in fiscal year 1990 to 43 in 1994. While 72 new medical devices per year were approved in the mid-1980s, the number fell to 12 annually by 1992 before increasing somewhat in recent years.

The total time from discovery of a drug to FDA marketing approval increased from an average eight years in the 1960s to 13-15 years today. Due to these delays and the enormous amount of clinical data required by the FDA during clinical testing, the cost of developing and marketing a new drug was estimated to be more than $359 million in 1993.Speeding up the approval process would save lives as well as reduce the cost of developing new drugs. For example, 1,200 Americans died of kidney cancer while waiting for FDA approval of Interleukin-2, a drug that was already in use in nine European countries.