Healthy Skepticism Library item: 20538

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

The FDA comes to life
The Lancet 1991 Jun 22; 337:1533

Abstract:

Not all the news in health politics here is gloomy. The Food and Drug Administration, camatose for a decade, continues to grow more militant in fulfilling its responsibilities. The difference is its new chief, Commissioner David A. Kessler, who arrived in the job late last year with credentials that could only have been fashioned in an administrative Olympus. A physician, lawyer, and specialist in food and drug regulation, he was medical director of the major hospital under the Albert Einstein School of Medicine at the time of his appointment. He also could claim a congenial relationship with one of the chieftains of the antiregulatory political right, Senator Orrin Hatch, Republication of Utah, for whom Dr Kessler was a consultant a decade ago. Kessler was also a member of a Bush administration study committee that looked into FDA and found little to commend in the eviscerated hulk left from the Reagan era.

Nonetheless, few gave much credence to Kessler’s commitment to dragon-slaying. Kessler age 40, is grave in manner, undemonstrative, and lacks the TV-era artifice generally deemed crucial for effectiveness in public affairs. The President who appointed him has shown little interest in domestic matters, and recently admonished the American people to look after themselves rather than rely on government. FDA is an arm of the Department of Health and Human Services, an arthritic colossus on the federal landscape.

Surprise. Confirmed by the Senate last November, Kessler became a kind of can-do rarity in domestic government, announcing crackdowns on ambiguous food labelling, assaults on the promotion of prescription drugs for purposes unapproved by the FDA, and actions against other misdeeds that have long gone unchallenged. He is hiring 100 additional criminal investigators and has proclaimed an ambitious agenda for the agency that, by many measures, is the most important guardian of the bodily well-being of the American people.

Kessler’s announcements of regulatory actions, threatened and delivered, are prominently reported by press and TV, and in a generally approving fashion. Among his strongest supporters is an ancient blood-fuedist of the FDA, Dr Sidney Wolfe, Director of the Public Citizen Health Research Group, medical wing of the Ralph Nadar empire. Over many years, Wolfe’s organisation has repeatedly sued FDA and its officials on charges of neglect of statutory responsibilities, particularly in assuring the safety and efficacy of pharmaceutical drugs. Before Kessler’s arrival at the agency, Wolfe’s contacts with the FDA took place either in courts of law or in surreptitious relations with clandestine allies working inside the agency. Under the new regime, Kessler and Wolfe meet monthly for lengthy private discussions; the protocol of their sessions provides for alternating the meeting sites between their offices.

Some of the regulatory actions recently taken by FDA are peripheral to the promotion of healthfulness but have served as blockbusters for drawing the attention of industry and the public. One of the earliest in Kessler’s tenure concerned the use of the word ‘fresh’ on containers of citrus juice made from concentrated juices. The nutritional difference in probably negligible, if any. But freshness and purity are holy values in American food fetishism. The banishment of “fresh” from inappropriate usage was widely reported.

With fat and cholesterol widely denounced as enemies of health, food manufacturers have responded with barrages of health claims for their products, mostly to the effect that they contain little or nothing of the villainous substances. “Contains No Cholesterol” is proclaimed on products that do not and never have contained cholesterol. The old FDA simply ignored these truthful deceptions. Not so the new FDA, which has unequivocally told manufacturers to clean up their labels. “The FDA”, Kessler announced in a recent address, “will systematically seek out partial truths and misleading statements on the American food label. That’s our job”, he said, “and I have no problem acknowledging it”. Some of the biggest food manufacturers, including Kraft General Foods, announced the elimination of low-fat and fat-free claims on their labels after Kessler denounced the term as misleading. The important information, he said, is fat per serving. Attributing the practices to competitive pressures, industry has promised to go straight.

Of a more serious nature, the FDA has taken off after the wily promotion of drugs for purposes other than those approved by the agency. Industry may not legally advertise or promote drugs for purposes unapproved by the FDA. But, in accord with the great tradition of physician sovereignty, doctors are at liberty to prescribe drugs as they please, regardless of the purpose for which the drugs were approved. One need not be a giant in marketing or jurisprudence to sight the opportunities here. Currently under FDA scrutiny is Johnston & Johnston, whose subsidiary Ortho Pharmaceutical Corporation manufacturers ‘Retin-A’ (tretinon), approved by the FDA only for treatment of acne. Three years ago, Ortho announced that ‘Retin-A’ is an effective wrinkle-reducer, thus alerting American consumers to the availability of a treatment that probably ranks just behind a cancer cure in the prayers of the ageing. Under the old regime, Johnston & Johnston had nothing to fear. Kessler’s FDA, however, has referred the case to the Justice Department, initially with recommendations for a civil suit. It has since been reported that the Justice Department is looking into the possibility of a criminal prosecution.

There’s a good deal of speculation about the motives and durability of the Bush administration’s tolerance of a regulatory official who is so far out of line with the regulatory ideology. As Vice Presidenet in the Reagan administration, Mr Bush chaired a regulatory task force that assured the pharmaceutical industry of cooperation from the FDA, rather than the adversarial stance that is written into the agency’s statutory charter. The effect was to defang FDA without any accompanying improvement in the quality of its decisions or public protection against avaricious drug…