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The Fda May Soon Be Able To Back Up Its Snarl


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THE FDA MAY SOON BE ABLE TO BACK UP ITS SNARL

These days, the Food & Drug Administration seems like a pit bull, growling at everything from misleading food labels to questionable drug promotions. But for a watchdog entrusted with guarding the public health, the FDA often has a Chihuahua's bite. In case after case, the agency has been unable to act fast when food and drug marketers flout the law. Despite mounting evidence in 1989 that a diet supplement known as L-tryptophan was killing people, for example, it took many weeks for the FDA to force all distributors to stop selling it.

That's why Congress is moving to give the agency a sharp new set of teeth. On Oct. 10, the House health and environment subcommittee, headed by Representative Henry A. Waxman (D-Calif.), approved a sweeping measure that would give the FDA power to do everything from recalling products on its own to levying huge fines. Despite opposition from the food, drug, and cosmetic industries, not to mention the White House, the legislation is supported by such powerful lawmakers as House Energy & Commerce Committee Chairman John D. Dingell (D-Mich.), a co-sponsor (page 56). Some version of the measure stands a good chance of passage. Industries overseen by the agency are battling the bill at each step. "The agency has all the power it needs," maintains H. Edward Dunkelberger, general counsel for the National Food Processors Assn. If given additional authority to embargo products, subpoena documents, and inspect

company records, foes argue, the FDA could go on fishing expeditions through company files, learn trade secrets, and arbitrarily seize products for tiny violations. "It's using the proverbial stick of dynamite to kill an ant," fumes Jeffrey I. Nedelman of the Grocery Manufacturers of America.

'SKELETONS.' Supporters dismiss such rhetoric as the product of guilty corporate consciences. "Companies all have skeletons in their closets that they don't want the FDA to uncover," says Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, an outfit founded by Ralph Nader.

For their part, FDA officials point to dozens of cases where the agency was powerless to act quickly to protect the public. In 1982, when agency officials suspected that Beech-Nut Nutrition Corp. was selling sweetened, flavored water as "apple juice," they were barred from inspecting production records that could have proved their suspicions. As a result, the baby "juice" remained on the market for the better part of a year before the agency marshalled enough evidence to engineer a recall. The FDA argues it could operate far more efficiently if it didn't have to spend years persuading courts or grand juries to acquire records or seize products. "It's absurd that an FDA inspector can't look at the amounts of raw materials in food being sold to the American public, or even do a silly thing like stop the movement of a product," says Alan L. Hoeting, the agency's chief enforcer.

BEARING FRUIT. Yet industry opposition is having its intended effect. After Waxman introduced the bill early this summer, food and drug company lobbyists found sympathetic ears at the Council on Competitiveness, a White House group headed by Vice-President Dan Quayle. The council aims to cut through regulatory red tape. The night before July 17 hearings on the bill, council officials squelched FDA Commissioner David A. Kessler's prepared testimony, which supported greater enforcement powers. Since then, Quayle and conservative allies have won an internal Administration struggle, inducing Health & Human Services Secretary Dr. Louis W. Sullivan to announce on Oct. 8 that the White House would veto the legislation as written--though Sullivan last June supported a similar bill penned at HHS.

Waxman and Dingell have already softened some of the bill's features, such as a provision that would have authorized the FDA to use electronic snooping devices. And they are prepared to narrow others.

The concessions may be bearing fruit. In a recent letter to Waxman, Upjohn CEO Theodore Cooper said that "with minor amendment and clarification," the drug giant would support the bill. Other concessions may lure more companies. But in the end, even the watered-down version expected to be approved would make the FDA's bite as fearsome as its bark.

A STRONGER FDA Representative Henry Waxman's bill, vigorously opposed by business, would give the Food & Drug Administration the power to:

--Inspect company records if the agency suspects that a food, cosmetic, or over-the-counter drug is bogus or adulterated

--Subpoena documents to assist in investigations

--Seize products without first proving that they have moved in interstate commerce

--Impose civil penalties of up to $250,000 for each case where companies break the law

DATA: BWJohn Carey in Washington


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