There is a consensus that the drug approval-process in the United States is too slow, expensive and inefficient. The U.S. now lags behind Great Britain and Western Europe in introducing new medical technologies, and patients are denied access to therapies they need to live healthy lives or even to survive.

• The average time from chemical synthesis to marketing a new drug has more than doubled since the mid-1960s, from six years to almost 15 years.

• Of the drugs approved for use from 1987 to 1993, 73 percent had already been approved in other countries.

• During the 1960s, more anticancer agents were available to patients in the U.S. than in Great Britain, Germany, France or Japan; now U.S. patients have fewer anticancer agents available than patients in any of these countries.

• Medical devices that take four years to bring to market in Europe frequently require six years in the U.S.

• The cost of bringing a new drug to market now averages more than $350 million.

The Food and Drug Administration (FDA) regulates the testing, manufacturing and marketing of drugs and medical devices. In Europe, however, several countries use private "notifying" bodies to approve medical devices, and they accept the drug approvals of agencies in other countries. Many experts believe their system is just as safe as the FDA's.

A recent study recommends privatizing much of the FDA, based on experience in Europe. Under a privatized system, drug companies would hire private laboratories to certify the results of testing for safety and effectiveness. The FDA would regulate the certifying labs, and could reject their approvals.

In addition, the FDA would treat drug approvals in countries with comparable standards the same as certification by domestic labs.

Competition among private laboratories -- nonprofit and commercial -- and international competition of certifying agencies for drug approval business has encouraged the development of faster and less costly procedures overseas.