FTC SUGGESTS FDA SOFTEN DTC DRUG AD REGULATIONS

Wants Detailed Side Effects Data Dropped From Print Ads

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WASHINGTON (AdAge.com) -- The Federal Trade Commission wants the Federal Drug Administration to drop its requirements that pharmaceutical print ads run detailed
Typical of print pharmaceutical ads is this one for Aricept, an Alzheimer's treatment drug. The second page is dense with information about side effects, including "fecal incontinence," "gestrointestinal bleeding," "dehydration," "delusions" and "vertigo."
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drug side-effects listings. Instead, it wants drug companies to be allowed to use the same kind of "brief summary" risk warnings in print ads that are now used in broadcast commercials.

The FTC has also advised the FDA not to impede direct-to-consumer (DTC) pharmaceutical advertising as it moves forward with its review of rules for DTC marketing programs. Those programs now generate an estimated $2.4 billion annually in pharmaceutical industry ad spending.

Written suggestions
The FTC's written suggestions come in response to an FDA request for comments from the agencies, corporations and lobbying groups with an interest in DTC regulatory matters. The FDA is in the final stages of reviewing its own regulatory approach to DTC ads and is due to issue new guidelines by year-end. The FDA has thus far conducted a survey on DTC and solicited opinions from the pharmaceutical industry, consumer groups and advertising agencies during a two-day hearing in September.

Currently, pharmaceutical companies that elect to place a full-page DTC print ad must, in effect, place two pages because the side effects data most often fills an entire page with very small print.

While the change appears to benefit print publishers, the FTC said it does the opposite. The suggestion is that pharmaceutical companies end up with the choice of making broadcast buys, in which all their ad spending is on message, or print buys, in which half the cost goes for the second page of tiny text.

Magazine publishers
However, Rita Cohen, senior vice president of the Magazine Publishers of America, said publishers do not favor eliminating the requirement for a second page of detailed side effects information. She said publishers wanted language warning of a drug's risk that was easier for consumers to understand.

She said she wasn't sure what the impact on publishers would be if the requirement for detailed warnings was dropped as the FTC suggested.

The FTC suggestion is that the second full page of warnings could be replaced with a small "summary" that would provide consumers with information as to how to obtain further details about product risks.

"The sheer amount of information ... [required to] be disclosed in DTC print ads ... may deter consumers from reading the information or make it difficult for consumers to understand it," the FTC said.

The agency also said the detailed disclosures "are not particularly effective" in conveying information. "Most consumers do not read the brief summary information in print ads. Many who do read it likely do not understand it."

Shift the regulatory focus
In comments filed yesterday but released today, the FTC said, "Truthful, non-misleading DTC advertising benefits consumers." It urged the FDA to concentrate regulation on deceptive or misleading ads. "It can empower consumers to manage their own health care by providing information that will help them."

However, the FTC admitted that some DTC ads "may create misimpressions about drug risks and benefits," but said that because doctors correct the information there is "little, if any evidence" that the advertising increases drug prices or use of inappropriate drugs.

The FTC also urged several other changes.

It asked the FDA to allow drug companies to more easily make price comparisons in advertisements; to issue Internet advertising guidelines; and to require celebrity endorsers to have experience with the advertised drug.

The FTC also urged the FDA clarify a requirement that ads contain "fair balance." By this, the FTC meant that the FDA should make clear that "fair balance" isn't to present numerical parity between positive and negative information in each ad, but to present no impression that overstates a drug's benefits or understates its risk.

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