Big brother FDA

January 03, 1995|By Mona Charen

LET'S CUT government spending," conservatives used to argue.

"Oh, yeah?" liberals would reply. "We've already cut discretionary spending to the bone. What would you propose to cut, the Occupational Safety and Health Administration? The Food and Drug Administration?"

Thanks to James Bovard and the January issue of the American Spectator, the answer can now be an unflinching "yes."

David Kessler, the commissioner of the FDA, is just the man to bring into disrepute even the most justifiable agency of government. If you think the FDA toils faithfully to ensure that your food and medicine are safe and effective, read on.

Dr. Kessler was hired originally by George Bush, but in 1992, President-elect Bill Clinton could see that Mr. Kessler was his sort of regulator -- power-mad, contemptuous of private business and paternalistic -- and accordingly invited him to stay on. It was this sort of tongue-and-groove connection that prompted National Review's editor John O'Sullivan to remark, in 1992, that "We are not at the end of the Reagan/Bush era, we are at the midpoint of the Bush/Clinton era."

One of Mr. Kessler's first sallies in defense of all that is good and true was against Procter & Gamble, producers of a reconstituted orange juice called Citrus Hill Fresh Choice. The FDA, according to Mr. Bovard, threatened Procter & Gamble because the label was "misleading" to consumers. People might think the juice was fresh-squeezed, when in fact it was made from concentrate.

P&G responded that food manufacturers used the word "fresh" in 79 different ways, noted that the juice carton label also said "made from concentrate" and offered consumer surveys showing that people did not think the word fresh on a label meant fresh-squeezed.

This cavalier disregard for the health of the public was too much for Commissioner Kessler, who promptly ordered U.S. marshals to seize the juice -- 12,000 gallons -- and destroy it. As Mr. Bovard explains, "Federal law declares that a 'misbranded' or 'mislabeled' product is automatically unsafe and provides FDA with the authority to confiscate the merchandise."

But the FDA in the hands of David Kessler is more than a nuisance, it is a menace. On May 6, 1992, as part of the FDA's campaign against over-the-counter vitamin makers, 16 FDA inspectors and a squad of local police smashed in the door of the Tahoma Clinic in Kent, Wash., and confiscated $100,000 worth of office supplies, including address books and diaries. FDA claimed that Dr. Jonathan Wright, the owner, was engaging in dangerous health practices involving injectable B vitamins, yet the agency has never brought charges against Dr. Wright in court.

The FDA has been notoriously slow to approve new drugs, and Mr. Kessler has made it even slower. Mr. Bovard quotes the Competitive Enterprise Institute's estimates that as many as 15,000 people died unnecessarily during the FDA's review of the drug misoprostrol, which alleviates gastric ulcers. Twenty-two thousand heart patients might have lived, but for the FDA's delay in approving streptokinase, which dissolves blood clots.

Even more incomprehensible is the FDA's authoritarian suppression of information about potentially beneficial new uses for drugs already on the market. Aspirin, for example, has been shown in study after study to prevent heart attacks when taken daily. Yet in 1989, the FDA forbade manufacturers from advertising this benefit on the grounds that aspirin was not labeled as heart medicine.

The pharmaceutical company Merck found that its hypertension drug Vasotec was also highly effective against congestive heart disease. But the FDA barred Merck's sales force from informing doctors of this effect. To complete the absurdity, the research on Vasotec that led to the discovery of its effectiveness against heart disease was funded by the National Heart, Lung and Blood Institute, a federal agency. As Mr. Bovard notes, "we have the bizarre spectacle of one federal agency prohibiting the dissemination of another agency's research."

Meanwhile, the folks at FDA take taxpayer time and money to review and approve new products such as new wheelchair cushions.

Do we need an FDA? Sure. But we also need a vigilant Congress to oversee the agency and trim its sails. Save us from those who would save us from reconstituted orange juice, uncomfortable wheelchairs and lifesaving medicines.

Mona Charen is a syndicated columnist.

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