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.

This ever-growing role for the FDA has resulted in a "drug lag" in the introduction of new pharmaceutical products compared to other industrialized 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 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 drugs eligible to use the FDA's "abbreviated" application process skyrocketed from 23 months in 1990 to 38 months in 1993.

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.

Source: Jeffrey J. Pierce, "Dangerous Excesses: A Look at the Food and Drug Administration," Issue Analysis No. 13, November 9, 1995, Citizens for a Sound Economy Foundation, 1250 H Street, NW, Suite 700, Washington, DC 20005, (202) 783-3870.