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 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.

Before his appointment to the FDA, FDA's chief legal counsel Daniel Troy represented drug companies that challenged FDA actions. He also represented the Brown and Williamson Tobacco Corp. in the tobacco industry's successful suit against FDA efforts to regulate advertising and promotion of tobacco. A federal appeals court in 1998 upheld Troy's argument that tobacco isn't a drug and the FDA couldn't regulate it under the Food, Drug and Cosmetic Act. The U.S. Supreme Court later agreed. Also in 1998, Troy successfully fought the FDA to allow drug companies to provide doctors with articles that discuss unapproved, or "off-label," uses of their medications.

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 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, 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 care professionals. (The standards of clarity for broadcast drug ads were updated in 1997.)

As a result, the so-called "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 read more plainly. The FDA soon will propose changes intended to do that, McClellan told Knight Ridder in an interview.

The clarity problem is probably the easiest to fix. Among the 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.
  
• Because the FDA is understaffed, 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 of how safe and effective advertised drugs are.
  
• 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. Congressional investigators say that's slowed efforts to crack down on dubious ads.

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 problem prescription-drug 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 last July.

The FDA issued a warning letter to Aventis Pharmaceuticals of Bridgewater, N.J., last 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 liberal consumer watchdog group in Washington, said it reflected less stringent enforcement.

"If you are a drug company, you have little to fear about putting out an ad that overstates the benefits and understates the risks of a drug. You're just not going to get caught, because they're not doing very much enforcement anymore," Wolfe said.

Tom Abrams, the director of the FDA's drug marketing unit, wouldn't comment on "internal processes" that might help explain the decline in enforcement letters from his office.

FDA spokesman Peter Pitts said enforcement letters weren't the sole measure of the agency's effectiveness at policing ads. FDA officials also meet with drug-industry trade groups, law firms and marketing and ad agencies to encourage industry self-compliance, Pitts said.

"The end goal is to ensure that a pharmaceutical company is complying and being truthful in their communications with the public," Pitts said. "If we accomplish that through tougher letters or (using the agency's) bully pulpit - it's the end result, not the means, that need to be measured."

Marc Scheineson, a partner in the Washington law firm of Reed Smith, LLP, and a former FDA associate commissioner, said drug companies often helped FDA enforcers by tipping them off about competitors' ads that they considered misleading. Drug companies also provide doctors with copies of FDA violation letters sent to competitors.

"It has become quite a predatory environment," Scheineson said. "Competitors are doing a lot of (FDA ad reviewers') work for them."

Under the Bush administration, the FDA has been less aggressive about pursuing drug companies that run questionable ads.

In January 2002, the office of the FDA's chief legal counsel, Daniel Troy, began reviewing the evidence behind all proposed enforcement letters, with an eye toward scuttling any that might not hold up in court. Claude Allen, the deputy secretary of the Health and Human Services Department, the FDA's parent agency, ordered the change in policy.

An October 2002 study by the General Accounting Office, the investigative arm of Congress, said that before Troy's reviews began, FDA notices went out within days after a problem ad was spotted. Under the new policy, clearing the letters took 13 to 78 days, the report said. "Some regulatory letters may not be issued until after the advertising campaign has run its course," the GAO found.

The FDA's Abrams wouldn't say whether delays persist. "We have worked together collaboratively (with Troy) to reduce the time it takes," he said. The FDA's goal is to get letters out in 15 days.

Rep. Waxman, a longtime critic of the FDA, is expected to release a new staff study Thursday saying the agency's ad-review system has gotten worse since the GAO report.

Scheineson, who represents drug companies in advertising and promotional matters, said the agency's problems and Troy's influence might be having a "chilling effect" on FDA actions against deceptive drug ads.

FDA managers, Scheineson said, may "figure it's not worth it to spend all of their time and limited resources going after one ad (with) all the kinds of justification and substantiation that the chief counsel's office is going to require."

Before his appointment to the FDA, Troy represented drug companies that challenged FDA actions. He also represented the Brown and Williamson Tobacco Corp. in the tobacco industry's successful suit against FDA efforts to regulate advertising and promotion of tobacco. A federal appeals court in 1998 upheld Troy's argument that tobacco isn't a drug and the FDA couldn't regulate it under the Food, Drug and Cosmetic Act. The U.S. Supreme Court later agreed.

Also in 1998, Troy successfully fought the FDA to allow drug companies to provide doctors with articles that discuss unapproved, or "off-label," uses of their medications.

Troy declined a request to be interviewed.

To review the Food and Drug Administration's enforcement actions against specific prescription drug ads, go to

http://www.fda.gov/cder/warn/warn2003.htm

Copyright 2004 Knight-Ridder

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