An Underutilized Phrase in SEM?

I suspect that "FDA-approved," "FDA-cleared," "approved by the FDA," and similar phrases are not fully appreciated by marketers of prescription products.

There is a tendency of marketers of prescription products to put on their blinders and see themselves and their product's performance solely in the context of other prescription products. Who's one slot above us on the IMS Health Rankings and who's one slot below? Are we gaining or losing ground?

But for consumers (and even HCPs for certain conditions), the decision set (your actual competitors in the marketplace) include many non-prescription, and even non-drug treatments. Dietary supplements, homeopathic remedies, and even home cures are legitimate considerations for treating many conditions, and many consumers don't distinguish between all of these categories as rigidly as people in the pharmaceutical industry.

However, the public in general holds the FDA in high esteem, and though criticism of the FDA certainly exists, most consumers consider the fact that the FDA has reviewed and approved (or cleared) a product as a guarantee of the product's quality and overall safety.

As such, the phrase "FDA-approved" can have significant value in a context (such as search engine marketing results), where the competition includes many products that are not reviewed, approved, or cleared by the FDA.

As part of FDAMA's passage in 1997, the prohibition on using this phrase was removed from the FD&C Act.

Since the implementation of FDAMA, FDA has not taken any actions for including the phrase "FDA-approved" or its variations in what otherwise would qualify as a reminder ad, and although FDA has never explicitly endorsed the phrase as being compatible with the reminder ad format, it certainly seems to qualify.

A reminder ad may not include any "representation or suggestion relating to the advertised drug product." 21 CFR 202.1(e)(2)(i) And the phrase "FDA-approved" certainly does not seem to violate that prohibition.

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