Drug Ads and The Learned Intermediary Doctrine

I think it all started with Bob Dole a few years back.

I recall seeing the former senator sitting before a fireplace, describing his most intimate medical problems in a commercial for Viagra on national television.

Since the, we’ve heard about the hormone replacement medication of former Charlie’s Angel Cheryl Ladd, golfer Jack Nicklaus’s endorsed artificial hop, and Olympic skater Dorothy Hamill’s Vioxx-aided struggle with arthritis, before the drug’s recall.

Sen. Edward Kennedy (D-Mass.) And Sen. Michael Enzi ®-Wyo.), the chairman and ranking Republican of the Health Committee, introduced legislation this Feb. 1 that would give the Food and Drug Administration (FDA) new authority to impose safety requirements on the promotion and distribution of medicines once they go on the market, including restrictions on consumer advertising.

Another bill introduced this year by two other senators calls for restructuring the FDA to create a new drug safety center. The House is also studying legislation that would require a two-year moratorium on advertising new drugs, and deny pharmaceutical companies tax deductions for costs associated with direct-to-consumer advertising of prescription drugs.

A recent study published in the Annals of Family Medicine criticized such drug advertising, saying that television commercials of drug companies provide "very little education value" for consumers.

Dominick Frosch, the UCLA researcher who conducted the study, said that the ads "contribute to people believing they need more drugs than they probably need." The study, released in late January, examined ads for popular drugs such as Allegra (for allergies), Ambien (insomnia), Celebrex (arthritis), Cialis (impotence), and Zoloft (depression).

It found that 95 percent of the ads relied on an emotional appeal, 58 percent claimed the drug was a medical breakthrough, and most ads left out important information, such as who is at risk.

A leading trade group, the Pharmaceutical Research and Manufacturers of America, said that new guidelines have been enacted since these commercials were aired, but the guidelines are merely voluntary. Members of Congress still see a problem with the lack of balance in the ads’ failure to explain risks as well as benefits.

A Consumers Union study released earlier this year found that 40 percent of doctors said that advertising directly to consumers did not serve the public interest. Some in the medical profession criticize prescription drug ads aimed directly at the consumer for fear that they create demand for wants instead of needs.

They point to a September 2006 Consumer Reports article that revealed that Sepracor, the manufacturer of the sleep-aid Lunesta, spent $227 million on advertising in 2005 after introducing the drug in April 2005. Prescriptions for Lunestra totaled 98,471 in April 2005; by December, that number more than quadrupled to 477,877.

The FDA does not have the authority to ban ads; it can only demand that a company pull a misleading ad after it has run. Currently, the FDA has minimal staff to police such advertising. The United States and New Zealand are the only two developed countries in the world that allow prescription drug ads, and New Zealand is considering banning such commercials.

In this country, pharmaceutical companies spent $4.2 billion in advertising in 2005. Just in the first nine months of 2006, spending on drug ads rose 8 percent to $3.3 billion, according to TNS Media Intelligence, which tracks such marketing.

Certainly there is something to be said for educating the consumer, but adding billions of dollars to the already soaring health-care bill – in the name of education – appears to be going overboard. Patients already pay too much for prescription drugs, and you can be sure it is the consumers and employers who are picking up a good part of the tab for these television commercials and print ads.

Whatever happened to relying on your doctor to keep up with the latest drugs on the market? Medical devices markers and prescription drug manufacturers once limited their advertising to trade journals targeted to physicians and information sent directly to doctors. Since 1998, the year after the FDA eased restrictions on consumer drug ads, that all changed.

Courts need to be made aware of this phenomenon in light of the learned intermediary doctrine, which relieves drug and medical device manufacturers of a duty to warn a patient when the manufacturer has provided an adequate warning to the medical community.

The more direct-to-consumer advertising that drug manufacturers undertake, arguably, the more this doctrine is eroded. If drug companies insist on reaching out directly to the consumer, they had better he prepared for an erosion of the doctrine, because all of the risks for each patient cannot be conveyed on 30 or 60 seconds.

Federal legislation that would allow the FDA to monitor the ads before they hit the airwaves certainly sounds more reasonable than allowing drug companies to go unchecked in their marketing campaigns.

To head off this legislation, earlier this year the pharmaceutical industry and the FDA unveiled a $393 million proposal that would not only provide a renewal of "user-fee" payment from the drug industry that allows the FDA to fund the agency’s drug review process, but would increase these fees to allow the FDA to screen the direct-to-consumer advertising before it airs.

Congress should pass the FDA user-fee legislation so that the drug industry has a check on its rampant pushing of pills.