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PRESCRIPTION DRUG "REMINDER AD" AND PREAPPROVAL AD POLICIES ARE BEING RE-EVALUATED BY FDA; AGENCY HAS ISSUED 10 TO 15 LETTERS FOR VIOLATIVE REMINDER ADS

Executive Summary

FDA has "just issued maybe 10 or 15 letters" on violative "reminder ads" for prescription drug products, FDA Drug Marketing, Surveillance and Enforcement Branch Chief Kenneth Feather said Feb. 26 at a Food and Drug Law Institute meeting on advertising and promotion regulations. Reminder advertising promotes the availability of products that already have been approved. Reminder ads may discuss pricing information but may not address uses of the drug. Feather said that the agency is rethinking some of its policies on drug reminder advertising, "looking at reminder advertisements from the viewpoint of how [we] defined certain things in the past and how we might want to change that somewhat to tighten up the reminder ads to get them back to...what they were intended to be." The ads should announce only the availability of products and "not [get] into a lot of details," the FDAer noted. "If you looked at magazines and things recently you have noted that the reminder advertisement scene has gotten a little out of hand," Feather said. "They're saying an awful lot of things that reminder advertising should not say." The agency is also evaluating its policy on preapproval promotions, such as ads that preview an upcoming approval. Feather stated that "we are taking a hard look at preapproval advertising, especially that which mentions a particular product name." He added: "That does not mean at this point there's any great change but...there probably will be some modifications to the policies." Feather said that "there is a feeling within the division that some of the preapproval advertising has perhaps gone a little overboard and we need to tighten up on that a little bit." FDA is still working on developing a policy for direct-to- consumer (DTC) advertising of prescription drugs, Feather said. The agency hopes to issue a guidance in "the not-too-distant future." The advertising division is also working on a policy covering broadcast media. The policy will deal with "the brief summary scroll and some of the other requirements for [giving] prescription information," Feather said. FDA will be reconsidering the usefulness of the scroll of prescribing information that appears at end of Lifetime Medical Television's "Doctors' Sunday" programs, the FDAer noted. As part of its policy development, the division will initiate studies to evaluate "major statements" about a drug's side effects or contraindications that appear within or at the end of commercials. The studies may take the form of market testing in which various major statements will be looked at in an effort to make them more useful and more standardized. Feather noted that the major statements of ads on Lifetime may vary in length.
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