Male Lifestyle Drug Marketers Think FDA's Proposed Study on Spousal DTC Influence is Bogus!

Back in December, 2014, I reported in Pharma Marketing News that the FDA was planning to study "Spousal Influence On Consumer Understanding Of And Response To Direct-To-Consumer Prescription Drug Advertisements" (see "Does Your Spouse Influence Your DTC Viewing Experience?").

At about the same time, the new ad for Viagra, which featured a sexy woman (no man), aired on TV (read "Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!").

Of course, I thought the FDA should study how wives (or significant other spousal equivalents) might influence their spouses' (i.e., husbands') response to THAT ad.

But, no, the FDA will be using asthma drug ads in their study. Huh?!

It appears that the FDA is using a benign drug category to get results that it may use against Viagra and other male/female enhancement drug ads. AbbVie and Eli Lilly -- two marketers of lifestyle-enhancing drugs for men -- recognize this ploy and have submitted comments to the FDA in an attempt to shoot down the study.

What's their beef?

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In a Major Turnaround, FDA Now Requires "Low-T" Drug Label Changes & Safety Studies: Warns of Stroke & Heart Attack, Inappropriate Prescribing

FDA characterizes today's Safety Announcement requiring label changes for drugs that treat "low testosterone" merely "an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014." But it is obviously much more.

According to today's announcement,

1. FDA is "requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone."


2. "[FDA is] also requiring manufacturers [ of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products."

This is worlds apart from what the FDA said on January 31, 2014 regarding this issue. It is also worlds apart from what Public Citizen petitioned the FDA to do in February, 2014.

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