Ad regulators' headache

Overload: U.S. regulators are unable to keep pace with the volume of ads for pharmaceuticals in magazines and newspapers.

January 31, 2004|By Tony Pugh | Tony Pugh,KNIGHT RIDDER/TRIBUNE

WASHINGTON - It's hard to miss the boom in advertisements for prescription drugs in newspapers and magazines these days. It's even harder to know which ads to believe, because the federal government's efforts to police misleading ads haven't kept pace with the growth in drug advertising.

Drug companies spend about $1 billion a year - nearly a third more than they did five years ago - to market prescription drugs in general audience publications, and even more to advertise on television.

Doctors are under pressure from patients asking for drugs they've seen in ads.

Ads that show allergy-free people running through grassy fields and women smiling because their husbands "saw the doctor" about sexual dysfunction are intended to fuel the demand for brand-name drugs. But the ads, although they artfully showcase the drugs' benefits, aren't always as good at informing readers of the risks.

The Food and Drug Administration, which is supposed to protect people from ads that exaggerate the benefits or soft-pedal the risks of prescription drugs, is hobbled by obsolete standards, inadequate staffing and a growing reluctance to get tough with drug companies that produce questionable ads in newspapers and consumer magazines.

Although few people are in a position to weigh knowledgeably the risks and benefits of prescription drugs, let alone combinations of them, the FDA's standards for clarity of print ads date from the 1960s. Back then, drug ads appeared almost exclusively in medical journals, and most of their readers were health care professionals. (The standards of clarity for broadcast drug ads were updated in 1997.)

As a result, the "brief summary" that accompanies each ad to warn readers of possible health risks can run to more than 2,000 words. That's also why many "brief summary" warnings include nearly unintelligible sentences such as: "HMG-CoA reductase inhibitors interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production."

FDA Commissioner Mark McClellan and consumer groups agree that print ads for prescription drugs need to be written more plainly. Next month, the FDA will propose changes intended to do that.

The FDA sent 24 letters last year asking companies to stop misleading promotions of medicines, which is a decline in enforcement, according to a report from a U.S. House committee.

The clarity problem is probably the easiest to fix. Among the others:

Eighteen FDA reviewers were assigned to scrutinize the roughly 37,000 drug ads and promotional materials that drug companies submitted last year. The agency told Rep. Henry A. Waxman, a California Democrat, in 2002 that it would need to double its staff to assure adequate reviews.

Because the FDA is understaffed, drug ad campaigns sometimes end before the agency's watchdogs spot a faulty ad. When the FDA does object, drug companies sometimes respond slowly or incompletely, so consumers are left with misleading impressions of advertised drugs' safety and effectiveness.

Drug companies have little motivation to respond quickly to FDA complaints because the agency isn't using the legal authority it has to seize drugs or take violators to court. Instead, the Bush administration says proposed sanctions must pass a new review by the FDA's general counsel.

The FDA's most common sanction for a problem ad is a "notice of violation" letter that directs a drug company to yank or correct ads that contain false or misleading information or omit material facts about a drug's risks and benefits.

For more serious violations, such as repeated offenses or violations that could harm public health, the FDA sometimes issues a "warning letter," threatening to seize the drugs in question or to seek a court injunction.

Such sanctions are rare and getting rarer.

Between August 1997 and July 2001, the agency issued 44 notice-of-violation letters for prescription-drug print ads aimed at consumers, according to congressional testimony in 2001 by Nancy Ostrove, deputy director of the FDA's Division of Drug Marketing, Advertising and Communications. It also issued two warning letters.

During the next two years - July 2001 through July 2003 - the FDA issued 10 notices of violation and no warning letters, Janet Woodcock, head of the FDA Center for Drug Evaluation and Research, told lawmakers in July.

The FDA issued a warning letter to Aventis Pharmaceuticals Inc. of Bridgewater, N.J., in November after milder notices about ads for its cancer drug Taxotere failed to produce what the agency considered an adequate response.

Drug industry officials said the decline in enforcement letters reflects better compliance with advertising standards. Dr. Sidney Wolfe, a health expert at Public Citizen, a consumer watchdog group in Washington, said the decline reflected less stringent enforcement.

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