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What is PDUFA?

Intuitive Surgical: Robotic Heart Surgery Has Growing Pains

Intuitive Surgical ( ISRG ) is the unchallenged global leader in the emerging field of minimally invasive robotic surgery. Over the last three years, Intuitive has one of the two best performing stocks of companies listed on the Nasdaq stock exchange with a market capitalization of at least $10 billion. Only the stock of the Chinese search engine Baidu ( BIDU ) has been able to match that performance.

The Gov’t Controls Google’s Search Results for Your Brand. Surprised?

Did you notice that lately, every time you search for a pharma brand on Google, the #1 organic result is always the NIH? Always

Nobody Knows You’re a Fake Patient on the Internet!

Last night I had the honor of hosting the #socpharm “Tweetchat” session, standing in for Eileen O’Brien (@ EileenObrien ; Siren Interactive) who is the founder and regular host of that Twitter discussion stream. One issue discussed in last night’s session was Sara Baker, a “fake” patient created by MedSeek, an eMarketing company that does work for the pharma and healthcare industries. “Meet Sara Baker,” says MedSeek on its website.

Should Google Allow Pharma an Exception to Its Ban on Redirect URLs? (UPDATED)

Back in April 2009, I suggested that FDA might go after pharma marketers for using paid search redirects in Google Adwords (see ” The Next FDA Concern May be the Use of ‘Redirect’ URLs “). Such ads use visible URLs such as “flaccidmember.com” but, when clicked, lead to viagra.com or cialis.com

Is Your Brand a Digital Genius or a Feeble-Minded Idiot?

When it comes to digital IQ, some brands are geniuses and some are feeble-minded idiots, according to the “L2 Digital IQ Index” for pharmaceutical brands, a first-of-its kind measurement of the digital competence of 51 pharma brands across eight therapeutic categories. The index was created by think tank L2 in partnership with media agency PHD Network. They evaluated pharmaceutical brands’ digital presence across four criteria: Platform (40 percent, including site effectiveness and brand translation); Off-Platform Messaging (25 percent, covering digital marketing efforts such as online and mobile advertising); Search Engine Optimization (20 percent, based on visibility on top search engines); and Social Media (15 percent, defined by presence on popular 2.0 platforms)

Pharma: It’s Not About You

I was delighted to co-author the below article on the patient-centric approach for Med Ad News’ DotPharma eNewsletter a few weeks ago. I thought readers here might enjoy it as well: – - – - – - – - – - – - – - – - – - – - – Pharma, it’s not about you anymore Marketing and communications have fundamentally changed forever, and the pharmaceutical industry is no exception to this. Pharma communicators face new channels, new challenges, new rules, and seismic shifts in the way they reach both consumers and healthcare professionals

Consumer Advocates Step Up and Submit Comments to FDA Regarding Regulation of Social Media

The deadline has come and gone for submitting comments to docket FDA-2009-N-0441 regarding “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” You can find ALL of the comments here at Regulations.gov and easily download MOST of them here at fdaSM.com . Unfortunately, the latter does NOT include text comments that were submitted by individuals.

Making Sense Out Pharma DTC Spending Trends

ePharma boosters see the latest direct-to-consumer (DTC) advertising spending numbers as a positive sign that the drug industry is finally increasing its allotment to the Internet in its DTC marketing budget.

Merck Says FDA Should Approve the “One-Click Rule”

Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools ( find it here ). About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads.