According to Brandweek (“Advertising: FDA Floats, Then Sinks, Drug Ad Coupon Study” – subscription required), FDA “yanked” its Federal Register notice to conduct studies on the effect of coupons in print drug ads on February 9 — one day after I commented on this study (see “FDA, Coupons, and Sleep Aid DTC Ads“).

I don’t know how you “yank” notices from a public record, but Brandweek quoted Crystal Rice, an FDA representative as saying: “The agency withdrew the notice because the matter required additional internal consideration.”

There was no further comment from the FDA, nor do I find any entry in the Federal Register about “yanking” the previous notice. [I only assume there has to be another notice if just to prevent people from wasting their time commenting on the first notice!] You can still find the original notice in the FR, but if you can’t, click here. (There are some interesting studies cited there for those of you wishing to do some research on this topic).

In my previous post I basically accused the FDA of using the study design to engineer a “pre-emptive strike” on sleep aid drug advertising practices. As reported by Brandweek: “The focus on sleep aids appears to be a reaction to a run-up in activity in that category, some of which has been unusually bold. For instance, Ambien CR was launched with ads that screamed ‘Free Ambien CR,’ and had tear-off strip coupons like those on neighborhood handbills stuck to lampposts by people advertising rooms for rent.”

Smoking Coupon Path
Other experts thought the FDA was heading down a broader, more ominous path. Harry Sweeney, member of the PHARMA-MKTING online discussion group and Pharma Marketing Roundtable, for example, was quite outspoken about how the FDA would be going too far and his comments exemplifies what most industry people are thinking:

FDA better be careful going down the “smoking coupon” path to misleading consumers or they’ll find themselves being forced to conform to the more commonly accepted FTC burden of proof which requires the agency not only to assert that something is “misleading” (what FDA has been getting away with for years) but requires proof in a court of law that consumers actually have been misled. That would be quite a comeuppance for FDA.

Our government is caught up in its shorts right now over the whole cost of drugs issue and its anti-industry bias is showing.

When the HHS-OIG writes an opinion criminalizing charity (i.e. industry-sponsored indigent patient programs), and bureaucrats attack industry plans to help patients cover the “donut hole” in Medicare Part D by threatening to use “anti-kickback” statues against companies participating in donut-hole discount programs, you know we’re entering another Alice-in-Wonderland period. FDA’s participation in this farce is lamentable. They’re a better agency than that.

Well, Harry, you’ll be happy to know that the agency has backed down — it seems. I called the FDA and despite of — or because of — mentioning the dreaded “blog” word, I was unable to tease any more information out of FDA “spokespeople,” who obviously were not willing to do any “spoking” on this subject. They did offer, however, to get back to me if “any further information becomes available.” Oh yeah, I’m on their list baby!