Tuesday, September 30, 2014

Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations?

Dale Cooke (@PhillyCooke on Twitter) live tweeted from the FDLI's Advertising and Promotion Conference yesterday and asked the question:

"Do # of violation letters (low) reflect incr compliance or diff emphasis? #AdPromoFDLI"

In other words, is the number of warning letters low because pharmaceutical marketers have learned to be more compliant with FDA regulations or is there some other reason? I suggested it was due to the dearth of newly-approved drugs, but Cooke reminded me that so far this year the FDA has approved as many drugs as it did for all of 2013.

Anyway, to test my hypothesis, I plotted the number of letters vs. the number of newly approved drugs from 1997 through 2014 (to date):


Is there a correlation?

Monday, September 29, 2014

FDA's Jean-ah Kang Says Google Black Box Ad Format is OK. But Is It "Patient-Centric?"

Jean-ah Kang, Special Assitant to the Director Tom Abrams), Office of Prescription Drug Promotion (OPDP), FDA, has "officially" said that Google's Black Box Ad Format was "OK" as long as it was one click away from the package insert (PI). She gave her blessing at FDLI's Advertising and Promotion Conference today in Washington, D.C.

First, let's look at a mockup of the ad format we are talking about:

Google's Black Box Ad Format. Click on image for an enlarged view.
"Black Box" refers to the special warning about major side effects -- often death -- that certain drug package inserts are required to display prominently in a black box. Learn more about the Black Box Warning in the Pharma Marketing Glossary (here).

Recall that Google presented this format to the FDA at the November, 2009 public hearings (see here) and at least one pharma company -- Bayer -- actually ran an ad using this format (see here).

This format is only "OK" for reminder ads, which do not mention product benefits. Hence, in this case, a version of the "one-click rule" is sanctioned (the PI is just one click away).

There are few things I don't like about this format.

Correcting Misinformation: Eliminate the "Influence Prong," Says Pharma Industry

"It is difficult to envision a scenario in which a manufacturer’s participation in an interactive online or social media forum would not meet the low bar established by the Draft Guidance," says the Medical Information Working Group (MIWG) -- a consortium of medical product manufacturers -- in comments submitted to the FDA regarding the Agency's recent guidance on correcting misinformation about drugs and devices on 3rd-party social media sites. The "bar" MIWG is talking about is the bar that determines when a drug company has "influence" over the content of the site.

PhRMA, the drug industry trade group, refers to the "nebulousness" of the term, suggests that FDA "eliminate the 'influence' test," and adds this recommendation for ensuring an adequate "safe harbor" for correcting misinformation:
"PhRMA recommends that FDA will provide an adequate safe harbor for companies to correct misinformation about medicines online by expanding the scope of the Draft Guidance through elimination of the 'influenced' prong of FDA‘s definition of applicable communication. As discussed below, the term 'influenced,' when used to limit the proposed safe harbor for the correction of misinformation, is both vague and over broad."
Yep, PhRMA used the word "prong!" The devil is in the details.

Sunday, September 28, 2014

"Wikipedia is an Insane Place" - Pharma Should Be Wary About Correcting "Misinformation"

I've just finished reading the comments submitted to the docket regarding FDA's recent draft guidelines for correcting third-party "misinformation" on Internet/social media platforms such as Wikipedia.

The comment submitted by Eric Barbour, a moderator of Wikipediocracy (wikipediocracy.com), a website dedicated to criticizing Wikipedia, immediately grabbed my attention. Barbour did not mince his words of condemnation of Wikipedia:

"Wikipedia is an insane place, and it cannot be handled or used as if sane people administer it."

As evidence of that, I offer the image above left of Wikipedian Kevin Gorman, formerly known as "Wiki-Gnome."

I learned of Gorman from a presentation by Siva Nadarajah, General Manager – Social Media @IMSHealth, who spoke at CBI's recent "Social Media Compliance Strategies & Benchmarking Summit," which I chaired in Philadelphia. His slide presentation linked to a Youtube interview of Gorman (here).

But I digress. Aside from belittling the sanity of Wikipedians, Barbour had this piece of advice for the pharmaceutical industry:

"Any drug or medical company that openly follows the proposed FDA guideline will quickly find their accounts banned and their changes reverted. And the FDA will ultimately look foolish."

That's because of Wikipedia's "Bright Line" rule, which is taken as "gospel" by many Wikipedians. What is the "Bright Line" rule?

Thursday, September 25, 2014

Drug Industry Slams FDA's Social Media Guidelines: Part 1 (Social Media Platforms with Character Space Limitations)

Ever since the epic #FAIL of FDA's webinar that was meant to explain its recent social media guidelines, the agency has been the butt of jokes here on Pharma Marketing Blog and also behind pharma industry closed doors.

In particular, the agency was criticized for not being technically savvy enough to understand the nuances of social media and search engine advertising (read, for example, "Don't Follow FDA Guidance on Use of Google Adword Site Links").

Now, the industry's door is open thanks to comments recently submitted to the docket by industry groups and made public by the FDA. It's always interesting and educational to read these comments.

In this and subsequent posts, I will  summarize some of the main points made by PhRMA, Washington Legal Foundation (WLF), BIO, Medical Information Working Group (MIWG), the Patient, Consumer, and Public Health Coalition, and several pharmaceutical companies.

Let's begin with PhRMA's comments regarding FDA's guidelines for promotion via social media with character space limitations.

In its comments (here), PhRMA implies that FDA is hypocritical, or more accurately, "inconsistent:"

Tuesday, September 23, 2014

Don't Follow FDA Guidance on Use of Google Adword Site Links

In case you haven't realized it yet, the FDA is not very well-versed in the intricacies of new media, which may be why it took the agency so long to deliver guidelines for pharma's use of social media (see the PharmaGuy Social Media Timeline for details).

A good example of FDA's lack of digital expertise is its recommendation for the use of Google Adword site links. "Ad site links," says Google, "add value to your existing AdWords ads by providing additional links to specific, relevant content deeper within your site map."

FDA suggested that drug adwords -- even adwords for drugs with black box warnings -- can use site links to "convey the most serious risks associated with [the drug], including the boxed warning and additional warnings about fatal and life-threatening risks."

The guidance document includes this example of ad for the hypothetical drug Headhurtz:

FDA example of Google ad with site links. Numbers are FDA's counts of characters used/maximum characters allowed. Click on the image for an enlarged view.
"FDA would not intend to object to this sponsored link format," notes the Agency in its guidance document. Unfortunately, if a real drug ad followed this advice, the FDA might renege on its promise and "object."

Why is that?

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