While drug companies must submit direct-to-consumer advertisements to the U.S. Food and Drug Administration (FDA), the agency’s review of drug ads is often not completed until after the ad has been widely circulated. What does this mean for consumers? Advertised drugs are not necessarily safe, and drug advertisements should be looked at with discretion.

If the FDA finds a drug ad to be false or misleading, it will issue a regulatory letter to the manufacturer. In the late 1990s, the FDA issued more than 100 such letters per year, but as of November 2002, only 24 had been issued for the year. The decrease, thought to be the result of a new legal review of proposed regulatory letters, has raised concerns that potentially misleading drug advertisements may be gaining public exposure.

According to a Consumer Reports analysis of FDA regulatory letters from 1997 to 2002, the FDA charged drug manufacturers with a variety of violations including minimizing or omitting drug risks, exaggerating the effectiveness of the drug, making false claims that one drug is superior to another, promoting unapproved uses for drugs, promoting drugs that are still experimental, using incorrect or inconsistent labeling information, and giving false or misleading information to physicians.

Drug ads that received the most letters citing violations from the FDA since 1997 included:

• Claritin (allergy drug, 11 letters)
• Avapro (blood pressure drug, 7 letters)
• Flonase (allergy drug, 7 letters)
• Flovent (asthma drug, 7 letters)
• Celebrex (arthritis drug, 6 letters)
• Vanceril (asthma drug, 6 letters)
• Xenical (weight-loss drug, 6 letters)
• Zyrtec (allergy drug, 6 letters)
• Allegra (allergy drug, 5 letters)
• Avandia (diabetes drug, 5 letters)
• Ditropan (bladder problems drug, 5 letters)
• Pravachol (cholesterol drug, 5 letters)
  

What is concerning is that consumers tend to believe that drug ads are regulated. According to one recent study, some 43 percent of participants believed, falsely, that only "completely safe" drugs could be advertised.

Moreover, often patients discuss advertised drugs with their doctors, sometimes persuading them to prescribe such drugs. According to recent surveys, 69 percent to 80 percent of the time a patient requested a brand-name prescription doctors issued the medication.

However, drug ads can serve a useful purpose. They may increase awareness about certain health conditions and expose people to different types of treatment options. Drug ads may also help a patient to identify symptoms of a medical problem and bring those symptoms to the attention of their doctor. And, reportedly the drug industry believes that the FDA does an effective job of overseeing and regulating drug ads, the majority of which, manufacturers say, are accurate.

Nonetheless, the U.S. General Accounting Office (GAO) recently reported that FDA regulation of drug ads is limited. As a consumer, it is important to use your own judgment when viewing advertisements.

Consumer Report's issued the following guidelines for consumers:

• If an ad makes you think that the drug would be beneficial to you, find out more about the drug by looking for unbiased information. Then discuss the drug with your doctor.

• Ask your doctor questions such as: Do I have the condition the drug treats? What are the drugs benefits and risks compared with other drugs or treatment options? If the drug is new, do its benefits justify its higher cost and possible side effects?

• Don't pressure your doctor into prescribing a drug unless you have strong evidence from a reputable source that you really need it.

• If you suspect that a drug ad is misleading, report it to the FDA at (888) 463-6332.

Drug ads may also be contributing to the increase of prescription-drug spending, which increased 19 percent in 2000 and another 17 percent in 2001, according to Consumer Reports. While there is no direct evidence of an association between the two, lawmakers are beginning to look into the impact that direct-to-consumer drug ads may be having on such spending.

Consumer Reports February 2003 68:(2)33-37

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