DTC Advertising--A Fact Sheet

The Food and Drug Administration (FDA) recently conducted two days of public hearings to review attitudes toward direct-to-consumer (DTC) advertising of prescription drugs. This follows a series of internal surveys, reports and hearings conducted by the agency over the last three years, all with the intention of possibly revamping the rules governing DTC advertising.

Whenever a federal agency opens the door to public comment, it is a good thing. It allows every conceivable stakeholder to go on record with its views--whether supported by data or not--and prescriptions for policy changes. The downside to this open record, however, is that a lot of misinformation becomes permanently indited in the annals of history.

In the interest of setting the record aright, I thought this brief fact sheet on DTC advertising might be helpful.

DTC Advertising Plays an Important Role in Public Health

A number of medical studies and public opinion surveys indicate that millions more Americans are being treated for previously undiagnosed diseases since the FDA expanded the use of advertising for prescription drugs in 1997.

Advertising can provide valuable information that can help save lives. It can lead consumers to identify and find solutions for serious medical conditions by making them aware of previously unrecognized conditions and potential treatments. There is a common sense reason why this information enjoys the protection of commercial speech under the First Amendment.

For example:

Prescription drug advertising has been part of a public health revolution. It informs patients more about their health and it is directly responsible for getting patients to visit their doctors. Surveys by FDA (2002) and Prevention magazine (2004) indicate that DTC advertising prompted between 23 and 30 million Americans to talk to a doctor about a new or previously untreated condition.

Advertising produces new diagnoses of clinically important conditions. Faculty from the Harvard Medical School and Harvard Business School, in a study for Health Affairs, found that DTC ads prompted a sizeable portion (35%) of patients to visit a physician for clinically important conditions. The authors, Dr. Joel Weissman and Alvin J. Silk, noted these conditions are often under diagnosed and under treated, and that approximately 43% of new diagnoses and 51% of existing diagnoses were "high priority" conditions such as high cholesterol, hypertension, diabetes, and depression.

Advertising raises health awareness and can lead to earlier diagnosis and treatment. DTC reaches out to the estimated 6 million Americans who suffer from diabetes but have not been diagnosed. As many as 56 million Americans have high blood pressure, and yet it appears that 18 million are unaware they have this silent killer. Another 8 million Americans know they have high blood pressure but are not taking medication. Advertising also can help the U.S. Public Health Service achieve its goal of increasing from 23% to 50% the treatment rate for the 19 million Americans who suffer from depression.

DTC advertising encourages greater patient compliance. As many as one-third of patients fail to take all of their prescribed medicine. These ads help remind people to properly use their medicines. 33% of respondents to a Prevention magazine study said the ads reminded them to refill their prescriptions, and 22% reported the ads made them more likely to take their medicine regularly.

The physician must write the prescription. Patients cannot go to a pharmacy and request a particular drug – a doctor must write the prescription after examining the patient and recommend the best treatment. FDA nevertheless requires that DTC advertising be accurate and balanced, and FDA has aggressively increased its oversight of these ads.

Insurance companies can safeguard against inappropriate prescribing or overuse of prescription drugs. They determine what drugs to cover under their formularies and the amounts they will reimburse for drugs. Co-payments also are a critical component of patient compliance.

Prescription drug advertising is constitutionally protected commercial speech, and Americans recognize the value that these messages offer them. The U.S. Supreme Court for 29 years has continuously elevated the standard for protecting this and other forms of commercial speech. The Court has held, "As to the particular consumer's interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day's most urgent political debate."

These facts support both the value and legality of DTC advertising. Words to the contrary belie a long and persuasive public record that speaks in favor of allowing more of this kind of information to American consumers, not less.

(c)Adonis Hoffman 2005