Truth in Drug Advertising : Guidance and Violations

by Food and Drug Administration (FDA)

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There has been a great deal of discussion about the brief summary that accompanies DTC print ads. The typical brief summary is not brief and uses technical language. This is because it reprints all of the risk information from the physician labeling. People have complained that the brief summary cannot be understood by consumers. Aikin says, "Patients do not typically read the brief summary in DTC print ads unless they're interested in the product." Even then, she says, much information is likely glanced at, rather than fully read.

Public input and the FDA's own experiences with DTC promotion prompted the agency to publish two new draft guidances in February 2004: one on the brief summary, and one on help-seeking ads. These guidances are designed to encourage more informative, understandable ads.

Advertising Guidance

The draft guidance on the brief summary encourages companies to use consumer-friendly language and formats to convey prescription drug risk information — through a "less is more" approach. This approach focuses on the most serious and the most common risks of a drug, rather than listing every risk from the physician labeling. "Even though the information currently in the brief summary is complete, accurate, and in compliance," says Pitts, "it does not mean that patients are deriving the maximum benefit from it."

Sometimes marketers combine help-seeking ads with perceptually similar reminder ads in a way that causes the audience to perceive the two pieces as one advertisement. Appearing individually, these ads are exempted by regulation from the risk disclosure requirement. Combined, however, both ads can, in some cases, make a product-claim advertisement that requires risk disclosure.

The agency's recent draft guidance on help-seeking ads explains that help-seeking and reminder ads must appear distinct to avoid coming under the regulations for a product-claim ad. The draft guidance also addresses the separation needed between the two types of ads — in space for print ads, and in time for TV ads.

Those in Violation

For companies that don't follow the rules, DDMAC's possible actions include two types of letters — "untitled" and "warning." These letters address advertisements that make misleading claims about a drug's effectiveness — violations such as overstating the effectiveness of the drug, suggesting a broader range of indicated uses than the drug has been approved for, and lack of risk information. In both types of letters, DDMAC asks that the advertisement be withdrawn.

Warning letters, which are sent to companies that have violated the law repeatedly or that have committed serious regulatory violations in their advertising, typically request corrective advertisements to assure that the audience that received the original false or misleading information also receives truthful and accurate information.

Untitled letters are usually, but not always, sent to companies for first-time offenses or for less serious violations.

For example, the 60-second DTC broadcast television ad featuring "Digger," the well-known animated dermatophyte microorganism touting Lamisil (terbinafine), a treatment for nail fungus, was initially found to be false or misleading. The FDA sent an untitled letter to the makers of Lamisil for overstating the drug's effectiveness, minimizing its risk information, and making an unsubstantiated superiority claim. As a result, the manufacturer, Novartis Pharmaceuticals Corp., stopped running that ad.

DDMAC recently sent a warning letter to Bristol-Myers Squibb Co. about false or misleading promotional materials for Pravachol (pravastatin sodium), a drug approved to lower cholesterol in people with high cholesterol, to help prevent heart attacks in people with high cholesterol or heart disease, and to help prevent stroke in people with heart disease. One of the company's ads misleadingly suggested that the drug had been proven to help prevent stroke in all people worried about having a stroke, regardless of whether or not they had heart disease.

Another ad, directed at diabetes patients, misleadingly suggested that Pravachol had been proven to help prevent heart attacks and stroke in people with diabetes. Following the warning letter, the company created a corrective ad campaign acknowledging that Pravachol had not been approved for these indications.

Assessing DTC advertising is an ongoing process for the FDA. As more research surfaces, the agency will continue to evaluate DTC drug promotion and will take additional measures as appropriate to protect the public health.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.