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Going Backwards: Bush's FDA Action on Drugs Ads Declining
Published on Saturday, October 19, 2002 by the Boston Globe
Going Backwards
Bush's FDA Action on Drugs Ads Declining
by Alice Dembner

As drug companies blanket patients and doctors with ads touting their newest prescription drugs, the federal agency charged with keeping them honest and protecting the public appears to be backing off from policing those promotions.

The Food and Drug Administration demanded that companies fix distortions in ads only 18 times this year through September, down from 64 times for all of last year, despite rapid growth in the number of ads and leaflets promoting drugs. In addition, the FDA is actively considering whether it should loosen rules governing ad content.

Together, critics say, these actions could put the public's health at risk and help push drug spending - now at $154 billion - even higher as patients buy drugs they don't need.

''There's been a dramatic drop in enforcement actions,'' said US Representative Henry A. Waxman, a California Democrat who has protested to the Bush administration about the trend.

''The FDA seems to be siding with the industry to give them special treatment at the expense of the public. The public is going to be misled,'' Waxman said. ''People may end up paying higher prices for drugs that will do them less good.''

The FDA's chief counsel, however, said the agency remains committed to stopping false or misleading advertising. Daniel Troy said advertising oversight is focusing on fewer, more complicated cases, although he could not offer a specific example. Troy also said he is trying to ensure that every FDA action can stand up in court.

''We are not backing off the regulation of advertising any more than the courts compel us to,'' he said. ''Counting numbers is not in my judgment a very good way of assessing how credible and how strong an agency is in enforcing the law.''

Some critics suggest that Troy himself is behind the decline since his office became the gatekeeper for enforcement letters only recently and since he had challenged the FDA's authority over some aspects of drug promotion while he was a lawyer in private practice. Troy is also overseeing the agency's public examination of whether the FDA's regulation of drug promotions violates manufacturers' free speech rights. But Troy calls those criticisms ''politically motivated.''

The approximately 63 percent fall-off in FDA enforcement letters is occurring amid a public debate over the impact of drug advertising. Drug companies spent more than $19 billion last year to promote their drugs to consumers as well as doctors, nearly double the amount spent just four years earlier when the FDA eased rules on ads targeting consumers, according to IMS Health, which tracks the drug industry.

Ads directed at consumers represented an estimated $2.7 billion last year, and this year, the FDA is expected to review the content of a record 300 consumer ads and more than 35,000 pieces of promotional literature. Complaints to the agency about the content of the ads - typically from doctors, consumer advocates, or competitors - appear fairly stable, suggesting there has been no dramatic change in the accuracy or fairness of those ads.

At the same time, there has been a 60 percent decline since last year in the number of all FDA warning letters for various types of infractions, from clinical trials to marketing. These letters represent the first step in FDA policing. The decline coincides with an order from the administration last December requiring that Troy's office review all enforcement letters before they are sent to ensure they consistently apply FDA rules and are legally sound. Critics say the policy, combined with Troy's background, has had a chilling effect on FDA staff members who monitor drug company actions.

''The FDA is supposed to be a watchdog for patients, not a lapdog for special interests,'' said Senator Edward M. Kennedy, the Massachusetts Democrat who chairs the Senate's health committee. ''The precipitous drop in warning letters is an early warning signal that the administration may be planning to weaken an agency that is vital to the health of every American family.''

Troy said his oversight is not to blame for the decrease, because his office has rejected just 6 percent of the letters reviewed from February through September, including only two letters on advertising.

He said he couldn't fully explain the drop-off, but contended the agency is focusing on quality instead of quantity. ''We want to make sure what we do is credible and legally supportable and that everyone knows we can back it up by court action,'' he said.

However, Troy said that companies have generally responded quickly to enforcement letters on advertising by changing the content and that they have not challenged the letters in court. And he acknowledged that some FDA staff may be ''self-censoring.''

Protecting consumers from dishonest advertising is one of the FDA's main responsibilities under the federal Food, Drug, and Cosmetic Act. Rules require ads to contain balanced information about the risks and the benefits, although television and radio ads may greatly summarize the discussion of side effects.

FDA staff members review the material, focusing particularly on ads that are the subject of complaints, and send ''letters of notification'' or ''warning letters'' if they find problems.

One ad the FDA recently challenged promoted Lipitor, a top-selling cholesterol-lowering drug. The FDA said Pfizer Inc.'s ad in Time and Reader's Digest falsely implied that Lipitor was safer than its competitors. A company spokeswoman said Pfizer revised the ad immediately.

Waxman, however, said the FDA lets some misleading claims continue, such as a television ad that promotes the popular sleeping pill Ambien as ''working like a dream.'' Waxman said, ''The ad underplayed the risk of addiction. '' While the announcer says ''patients who abuse prescription sleep aids may become dependent,'' specialists who reviewed the ad for Waxman said the drug's labeling says even those who don't abuse it may become addicted.

FDA officials declined comment on the ad, and officials at the drug company, Sanofi-Synthelabo, did not respond to phone calls.

Dr. Peter Lurie, associate director of Public Citizen's Health Research Group, said the drop-off in warning letters ''acts as a signal to industry that the FDA is largely turning a blind eye to this issue,'' and he suggested that the public ''can expect a rash of more misleading advertising.''

But drug industry officials, who have long chafed under FDA ad restrictions, say they're not trying to mislead the public or take advantage of changes at the FDA.

''Any reduction in the number of letters hasn't decreased our focus on FDA enforcement,'' said Arnold Friede, senior corporate counsel for Pfizer.

Jeffrey Trewhitt, a spokesman for Pharmaceutical Research and Manufacturers of America, said that lobbying group had ''not seen any decline in the effectiveness of FDA regulation.''

Recent research has found that ads directed at consumers spur visits to the doctor and that most patients who ask their doctors for advertised products get them.

Trewhitt says ''direct-to-consumer ads empower patients by enabling them to learn about different treatment options,'' but 59 percent of the patients surveyed by the FDA in 1999 said the ads didn't talk enough about the risks.

Meanwhile, some are concerned the Bush administration will use free speech arguments to limit further the FDA's oversight of advertising. After a Supreme Court ruling shot down FDA rules barring pharmacies from publicizing custom combinations of drugs, the agency asked for public comment on its other advertising rules. Thousands of pages of comment include a Pfizer suggestion that the agency drop rules requiring mention of side effects in favor of a statement that all drugs have risks and that patients should consult their doctors.

On the other side of the spectrum, Health Law Advocates of Boston argued for rules that risks be presented in clearer voice-overs and larger type, and the American Medical Association said the FDA should maintain strict oversight to protect public health.

Troy said any policy changes will rest with Mark McClellan, the new commissioner.

© Copyright 2002 Globe Newspaper Company


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