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Drug ads come, go with little oversight

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 ones 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 now 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 while the ads artfully showcase the drugs' benefits, they 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 benefits or soft-pedal risks of prescription drugs, is hobbled by obsolete standards, inadequate staffing and a growing reluctance to get tough with drug companies.

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

As a result, the so-called "brief summary" 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 read more plainly. The FDA soon will propose changes intended to do that, McClellan said.

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

Only 18 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 Waxman, D-Calif., in 2002 that it would need to double its staff to assure adequate reviews.

Drug ad campaigns are sometimes over before the agency's watchdogs spot a faulty ad. When the FDA does object, drug companies sometimes respond slowly or incompletely, with the same result: Consumers are left with misleading impressions.

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.

These sanctions are rare and getting rarer.

Between August 1997 and July 2001, the agency issued 44 notice of violation letters for print ads aimed at consumers, according to congressional testimony in 2001 by Nancy Ostrove, the 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 notice of violation letters and no warning letters, Janet Woodcock, the head of the FDA Center for Drug Evaluation and Research, told lawmakers in July.

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