
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: THURSDAY, April 11, 1991                   TAG: 9104110261
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-5   EDITION: METRO 
SOURCE: The New York Times
DATELINE: WASHINGTON                                LENGTH: Medium

PANEL: FDA UNABLE TO COPE WITH DUTIES

A federal advisory committee appointed to study the Food and Drug Administration says the agency is overwhelmed and incapable of coping with vastly increased duties caused by the AIDS epidemic, a flood of food imports and advances in medical science and technology.

In a draft of its final report, the panel of 15 experts says that FDA laboratories and equipment are in abysmal condition, that some food factories are inspected only once every eight years and that the agency no longer has adequate scientific ability to evaluate new drugs, much less to keep up with "revolutionary advances occurring in the biological and medical sciences."

The report says many of the FDA's problems can be traced to its relatively lowly status in the federal hierarchy: It is one of many agencies in the Public Health Service, all of which report to an assistant secretary at the Department of Health and Human Services.

The commission is urging that the FDA be granted independent status within the Department of Health and Human Services, a move that would allow the FDA commissioner greater authority to issue regulations and enforce them.

The draft report says the agency needs additional staff and equipment to perform its mission properly, but the report does not specify the cost. Nor does it say whether the government should levy a fee on food and drug companies to augment the agency's budget, as the Bush administration has proposed.

The administration supports efforts to increase the agency's law-enforcement powers but opposes removal of the agency from the Public Health Service, saying that would hinder its cooperation with other units of the service, like the Centers for Disease Control.

Dr. Louis Sullivan, secretary of the Department of Health and Human Services, has publicly denounced proposals to remove the FDA from his department, and he reportedly is also cool to the idea of removing it from the Public Health Service.

The agency is charged with regulating products that account for 25 cents of every dollar spent by American consumers - everything from soup to nuts, from suntan lotion to tomatoes and ice cream, from eyedrops and hearing aids to artificial heart valves, AIDS drugs and shampoo.

by CNB