Almost one-half of Wyeth’s new Pristiq print DTC ad creative, which I cut out from this week’s Newsweek magazine (see left), is devoted to presenting risk information, including a black box warning about suicide risk that FDA now requires for all antidepressant drugs (see here ). The TV ad debuted last night during the depressing show Earth 2100 on ABC (see here ). I would estimate that 30 seconds of the 60-second TV ad is also devoted to presenting risk information (find the TV ad on the Pristiq website here )

DDMAC’s (FDA) recently-released “Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion” ( pdf file here ) focuses almost exclusively on print and broadcast promotional ads. It mentions the Internet — where patients most often go first to find information on health (see, for example, “The Empowered Patient: What It Means for Pharma Marketers”; PMN Reprint #84-02 ) — only once by way of example, as in: “Example 13: If a Web site for a product approved to treat high blood pressure presents information about a product’s benefits in postmenopausal women, any risks specific to postmenopausal women are particularly material.” To illustrate how non-specific this is with regard to the Internet, all you have to do is substitute “Print ad” for “Web site.” Perhaps this is FDA’s way of saying that the same rules apply to the Internet as to print ads. I agree, but only so far as a Web page or display ad on the Internet is just another static piece of text/graphic.

This morning I woke up to the news in an email alert that one of my client companies, sanofi-aventis , has been busy on the licensing front again after their recent deal with BiPar.  This time they have licensed two compounds from Exelixis , which are PI3-kinase inhibitors, XL-147 and XL-765.  You can read more about the deal itself on Mike Huckman's CNBC blog .  Regular readers of this blog will recall some previous posts on PI3-kinase inhibition such as here and here .  It's an interesting and relatively 'hot' pathway with the advent of mTOR inhibitors and the role of AKT-PI3-Kinase pathway in potentially reducing drug resistance and limiting the feedback loop seen with mTOR. The deal with a big Pharma suitor was inevitable after Exelixis signalled their intentions last December during the end of year pipeline update, according to my notes made at the time.  The slight development lead in this area turned into  a profitable deal for Exelixis.  At the recent AACR meeting in Denver, I noticed there were several others not far behind and some phase I data is expected to be presented next week at ASCO by Semafore on their PI3-kinase inhibitor, SF1126.  According to one of the abstracts : "SF1126 is composed of the pan PI3K inhibitor LY294002 conjugated to an RGD targeting peptide

FDA has just released a new draft guidance document: “Presenting Risk Information in Prescription Drug and Medical Device Promotion” (find the pdf file here ). I haven’t read the guidance yet, but according to a Reuters report, the guidance has some specific to TV ads: “Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers’ comprehension of potential side effects, U.S.

Consumer Reports, a publication I have long respected, has been very critical of DTC for years.