When Health and Human Services Secretary Louis W. Sullivan testifies before Congress Wednesday, he almost certainly will be asked one uncomfortable question: Would the Food and Drug Administration be better off outside his department?

Until recently, this notion would have been unthinkable. The FDA, after all, with regulatory authority over close to one-third of the nation's GNP, is the prize jewel of the HHS mandate, giving the secretary his greatest public visibility and authority.

But in the wake of growing concern over the politicization of the FDA and rising frustration over regulatory delays at the agency, thinking the unthinkable about the FDA is suddenly in vogue.

The issue of making the FDA more independent has come up repeatedly at hearings of the House Energy and Commerce oversight and investigations subcommittee over the past year. It also has been an almost constant theme at hearings during the past few weeks of the special Blue Ribbon Panel on the FDA, which Sullivan authorized last year to study the agency after the generic drug scandal.

Under consideration are a wide variety of proposals. Members of the Blue Ribbon Panel, which includes several former FDA senior officials and some of the country's most prominent food and drug law experts, seem most inclined toward altering the relationship between the agency and its HHS masters, removing the department's authority to review the bulk of FDA regulations.

Others, including some members of Congress and consumer and industry groups, go further, arguing that for the FDA to exercise its full authority, it should be removed from HHS and reconstituted as an independent agency. Legislation to do just that is expected to be introduced in Congress next year.

But the motivation of all parties is the same.

"The {House oversight} subcommittee has had a number of inquiries into FDA's activities: generic drug approvals, medical devices, food imports, the safety of the blood supply," said Chairman John D. Dingell (D-Mich.), whose panel called Sullivan to testify Wednesday. "In virtually every instance it is abundantly clear that the FDA lacks both the resources and the authority it needs to do its job, and that HHS has shown no inclination to correct the very serious consequences of a decade of neglect. If making FDA an independent agency will solve those problems, then we ought to look at it."

"The crux of the issue," said Sherwin Gardner, vice president of the Grocery Manufacturers Association and a Blue Ribbon Panel member, "is independence and authority."

Behind the push to reform the FDA is concern over the time it takes the agency to issue regulations. For example, the agency still has not issued rules for the Orphan Drug Act, which Congress passed seven years ago. And the Generic Drug Act, which Congress passed in 1984 and asked the FDA to write rules for within a year, did not even get draft regulations until 1989.

"The FDA should have had health labels out eight years ago," said Peter Barton Hutt, a former FDA general counsel now with Covington & Burling here. "But they couldn't do it. They are not out front of problems. They are only able to react to them."

According to many members of the Blue Ribbon Panel, the problem lies with FDA's position in the HHS bureaucracy. For much of its history, the agency was given full responsibility by the secretary to issue regulations. But in 1981, then-HHS Secretary Richard Schweiker rescinded that delegation of authority, adding two and sometimes three decision layers to the everyday functioning of the agency.

Also in the early 1980s, the Office of Management of Budget began reviewing FDA regulations, leaving the agency in what critics describe as a bureaucratic maw.

"In terms of regulations I cannot think . . . of an instance where HHS or OMB review has ever improved a regulation in a substantive way," William Schultz, a former Public Citizen attorney now with Rep. Henry A. Waxman (D-Calif.), told the Blue Ribbon Panel last Friday. "There are many times when it has seriously delayed regulations and there are a number of significant occasions where it has really harmed {a regulation.}" Schultz said he was not speaking on behalf of Waxman.

"The situation leads to delay and it leads to demoralization," said Mark Novitch, a former FDA deputy commissioner now with Upjohn Co. "It's a very inefficient system with little gain."

"There has to be some attempt to increase the stature and authority of the agency if it is going to attract the leadership it needs," said James Grant, a former FDA deputy commissioner and now chairman of T-Cell Sciences.

But if there is widespread agreement on the problems at FDA, there is no clear consensus on how to solve them. One solution, favored by many members of the Blue Panel Panel, is simply to ask Sullivan to reverse the position taken a decade ago by Schweiker and give the FDA control of its rulemaking.

In Congress, Dingell and Rep. Thomas J. Bliley Jr. (R-Va.) are seriously considering proposing an independently chartered FDA. This proposal, according to congressional sources, would foster more aggressive enforcement at FDA. Dingell has been concerned that the effect of HHS overview has been to frustrate the FDA's ability to investigate and prosecute offenders.

One option would be to make the FDA like the Environmental Protection Agency, an independent body within the executive branch. Congress also could set up the FDA like the Federal Trade Commission, operating outside the executive branch as an agency under the direct overview of Congress. The chief advantage here is that, under those circumstances, its regulations would no longer be subject to OMB review.

"You can achieve independence inside or outside the department in a number of different ways," said Gardner. "Breaking it out and making it independent . . . would clearly enable the agency to function in a more vigorous way than it is now functioning."