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FDA Looks To Make Drug Ads More Understandable, But Its Proposed Rules Offer Few Specifics.

The Food and Drug Administration is looking to make ads heard on radio or seen on television easier to understand by consumers. In a proposed update to its rules, the FDA says it aims to make sure that the side effects of advertised prescription drugs are “presented in a clear, conspicuous, and neutral manner.”

Under the FDA's current prescription drug advertising regulations, broadcast ads must disclose the major side effects related to the representations made in the commercial. The proposal would update that to require the spot include all the major side effects regardless of what claims are included in the ad. The proposal says the purpose of the rule change is simply geared to ensuring consumer-directed prescription drug ads give “a fair and accurate impression” of the drug being promoted.

In a set of four proposed standards, the FDA proposes that the side information be “readily understandable by consumers” and that audio information is “understandable in terms of the volume, articulation, and pacing used.” That means while doctors can understand medical terms, the ads should use “everyday words or terms that are understandable to consumers.” For instance, rather using the risk of “syncope” in a spot, the ad should mention a risk of “fainting” instead. The FDA says vague terms should also be avoided.

Although the proposal does not spell out any specific rules for volume, articulation, and pacing of the voiceover, it does say the commercial would violate the spirit of the rules if an “inarticulate” delivery hurts the audience’s comprehension of the risks being represented.

Television would face even stricter rules governing things like how the disclosures appear on-screen, but it again stops short of offering specific guidelines.

“The agency does not intend to prescribe a set formula for ‘clear, conspicuous, and neutral’ major statements because there is more than one way to achieve these standards in a television or radio ad,” the FDA proposal says. Instead, the FDA says it intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey risk information in prescription drug ads. “Sponsors have the flexibility to be creative in designing their ads as long as all of the standards listed here are complied with -- and the overall message that the advertisement conveys to consumers is accurate and non-misleading,” the proposal says (Docket No. FDA-2009-N-0582).

The rules would be in addition to regulations that the Federal Trade Commission puts on over-the-counter drug advertising. For radio, that has meant that volume, speed of the announcer’s delivery and placement of the disclosure has already mattered. The FTC says a “slow and deliberate manner and in a reasonably understandable volume” are required to ensure that the spot meets its “clear and conspicuous'' standards. The FTC also requires that no other sounds, including music, should appear in an audio ad during the side effect disclosure portion of the commercial. The FTC also says that the disclosures should immediately follow the ad’s claims.

The FDA says the rules laid out by the FTC offer a good place to start and says that whatever rules it adopts should be consistent with what broadcasters are already facing.

How big of a problem are things on radio? The FDA’s Division of Drug, Marketing, Advertising, and Communications did a review of five drug ads that aired on radio, and it found that two violated the existing fair balance regulations and also violated the rules that side effect disclosures be clear and conspicuous.

One of the more complicated issues it will face is how to define whether an ad is delivered in a “neutral manner.” The FDA says it is conducting empirical studies on the topic, but it is not yet ready to release the results. Depending on what the study’s conclusions are, it says it may open an additional comment window.

Given that the FDA has required radio and television ads to present the risks in a clear, conspicuous, and neutral manner since 2008, the FDA says if its proposal is adopted it plans to put the changes into effect in 90 days. It says that is enough time for drug companies and broadcasters to comply.

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