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FDA Panel Wants Closer Scrutiny of Drug Ads

Many of the ads are misleading, doctors complain

May 16, 2008

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The U.S. Food and Drug Administration (FDA) is taking a closer look at prescription drug ads, after an FDA advisory panel called for more extensive study of the effects the ads have on consumer behavior, particularly among the elderly and minorities.

The American Medical Association last week said many of the ads contain misleading information and need tighter controls.

Legislation that became effective this year authorizes the FDA to review ads before the public sees them and to impose fines if an ad is misleading. It also empowered the FDA to study the effect of such advertising on the public.

The panel's research found that drug ads do prompt consumers to see their doctors, but it is not clear if consumers understand the potential benefits and risks of the drugs being advertised.

The FDA is preparing a report for Congress about how ads impact consumers, especially older people and children, blacks, Hispanics and other minorities.

Drug companies spent nearly $29.9 billion in 2005 on advertising and promotion to hawk brand name products, according to a study funded by the National Institutes of Health published last year. More than $4 billion of that was spent on consumer ads compared to $429 million for ads directed at doctors.

Rep. Bart Stupak, the Michigan Democrat overseeing the House Energy and Commerce subcommittee investigation, wants drug companies to make commercials that are more clear or face tougher regulations and possible restrictions.

AMA's position

Doctors have long expressed alarm about the ads. Last week, AMA President-elect Dr. Nancy Nielsen expressed her organizations concerns in testimony before the House Energy and Commerce Committee Subcommittee on Oversight and Investigations.

"Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Nielsen. "Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs."

Critics have long pointed out that consumers are in no position to purchase prescription drugs without their doctor. The sole point of advertising to consumers, they claim, is to prompt consumers to specifically request a particular prescription drug.

At the hearing, the AMA discussed the need for FDA regulation over DTCA and shared guidelines for DTCA that address advertising content, disclosures, and audiences targeted.

"The AMA guidelines for DTCA can help ensure that patients receive information about prescription drugs that is accurate, educational, well-balanced and encourages patient-physician communication," Nielsen said.

"We look forward to working with Congress to achieve our shared goal - that direct-to-consumer advertisements focus on truly helping patients rather than maximizing pharmaceutical companies' bottom line," she added.

The ads work

A study last year bolsters the doctors' argument. A poll of Pennsylvania adults, taken 10 years after the first direct-to-consumer pharmaceutical television advertisement ran, suggests that nearly half of the participants have asked their doctor about a specific prescription drug or medical procedure they saw advertised.

According to The Patient Poll, conducted by the Pennsylvania Medical Society’s Institute for Good Medicine, 45 percent of Pennsylvania adults participating in the summer 2007 poll indicated that they have talked to their doctor about a specific drug and/or procedure that they saw advertised on television or in a magazine.

Critics of the ads say they lead to more prescriptions being written, often when it's not in the best interest of the patient. But there’s also a flip side: instead of getting upset about this situation, one physician says it’s better for his colleagues to be prepared for questions.

“Most physicians are divided about whether or not pharmaceutical advertisements directed towards patients are good,” said Dr. Peter Lund, founder of the Pennsylvania Medical Society’s Institute for Good Medicine.

“Some say it’s good to have patients informed, while others say it’s bad because of induced demand and incorrect self-diagnosing. Our advice to Pennsylvania physicians is to be alert to what’s being advertised and be prepared to answer questions since there’s a good chance they’ll be asked.”

A study published in the August 16, 2007, edition of The New England Journal of Medicine tracks a rise in total spending on pharmaceutical promotion from $11.4 billion in 1996 to $29.9 billion in 2005. Real spending on direct-to-consumer advertising increased by 330 percent during those years.

“There’s clear evidence that the pharmaceutical industry is spending more to promote medications,” Lund, an Erie, Pennsylvania urologist and incoming president of the Pennsylvania Medical Society, said. “If it wasn’t working for them, they wouldn’t be pumping more money into that budget area.”

While direct-to-consumer pharmaceutical advertisements can be traced back to 1981, the debate on advertising directly to patients accelerated within the medical community 10 years ago when the Food and Drug Administration changed policy to allow television advertisements directed towards patients.

“I don’t know a physician who hasn’t been asked by at least one patient about a specific drug they saw advertised,” Lund said.

Viagra ads

Some drug ads are more controversial than others. The AIDS Healthcare Foundation (AHF) last year filed a lawsuit against Pfizer Inc., the world's largest pharmaceutical company and manufacturer of impotence drug Viagra, over its marketing tactics and advertising.

AHF claims that Pfizer's Viagra advertising "has caused an increase in the spread of sexually transmitted diseases including but not limited to HIV/AIDS."

"Pfizer has engaged in and continues to engage in this conduct despite clear evidence of its illegality and harmful effects," the foundation charged. The lawsuit was filed in Los Angeles Superior Court.

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