Can a Moratorium-delayed DTC Ad Refer to a Drug as "New"?

Last month, WSJ Health Blog reported that "Drugmakers [Merck, Pfzier, J&J, to name a few] called before Congress to explain their direct-to-consumer [DTC] ads have agreed to wait six months before advertising newly approved drugs to the general public."

But I wonder if marketers in these companies have has asked themselves this question:

Given DDMAC’s policy that a new drug can only be new for six months after marketing launch, does that mean that brands who observe a 6-month or longer DTCA moratorium cannot claim "new" in their consumer ads?

That was a question recently posed by a client to my long-time colleague and Pharma Marketing Roundtable member, Mario Cavallini, Manager of Competitive Intelligence at Rosetta Marketing, who answered:

Interesting question; I don’t know whether anybody’s put those two together before.

The FDA guideline that a prescription med can only be "new" for six months comes (I believe, but could be mistaken on this) not from firm legislation but from "case law" pattern of rulings by DDMAC [Division of Drug Marketing, Advertising and Communications; the FDA division responsible for overseeing drug promotions].

In any event, the “six months for ‘new’ status” rule predates the PhRMA DTC Guiding Principles, which introduced the moratorium. Strictly speaking, the Guiding Principles only call for “an appropriate amount of time to educate health professionals about a new medicine or new therapeutic indication before commencing the first DTC advertising campaign” (by which, the Guiding Principles specifically means broadcast media and print advertising, but not Web sites and online media). How long and how broad the moratorium should be is left to the discretion of the individual company and brand. Six months is typical, but some have a one-year policy, some shorter.

PhRMA offers no guidance on whether the “new” clock starts at FDA approval, brand launch, or campaign launch. However, according to the FAQ page at DDMAC, the clock starts at campaign launch:

DDMAC generally considers that "New" is an accurate description of the marketing phase for six months from the time a product is initially marketed. This should be distinguished from the time the product is cleared by FDA for marketing.

So, on the one hand, it seems clear that the 6-month “new” clock starts at the end of the moratorium. But remember that the PhRMA guidelines only cover so-called mass media. DDMAC does not make such a distinction; if a brand puts up a brand Web site and runs banners within days of FDA approval, and then six months later starts running TV ads with “new” in the creative, I really can’t say whether that will be a problem or not.

Given that the point to the PhRMA moratorium is to allow marketing to HCPs before the messaging to consumers kicks in, my GUESS is that DDMAC would start the "marketing clock" at product launch, not campaign launch. That is, as soon as HCP marketing begins, that product is marketed and the 6-month clock starts.

Will this compel companies that observe a 6-month moratorium to NOT launch a Web site for the drug until the end of the moratorium? I don't think so because the FDA and the industry have always considered brand web sites as labeling, not DTC advertising.

What if they put up a banner ad on consumer sites to draw consumers to the brand site? Does that start the "marketing clock?"

Inquiring minds want to know!