Friday, January 23, 2015

Transparency is Good in Theory, But Not in Practice

I attended SMi's Social Media in the Pharmaceutical Industry conference this week and, as usual whenever I attend these conferences in the UK, I meet some very interesting people and get a new perspective on important issues that usually are not discussed in the U.S.

Take ethics, for example. I touched upon that topic in my presentation ("The Sorry State of Pharma Mobile Apps and What to Do About It"). But the presentation by Nick Broughton (@NickBroughton) was 100% devoted to "implementing social media ethics" in the pharmaceutical industry.

One of the principles Broughton espoused was "the first obligation is to act morally, not just compliantly." Pharma's first obligation, said Broughton, is to "act well. There's no defense if you make a mistake, especially in social media. When the rules are not clear -- and often they're not -- you have to rely on moral principles to make decisions that you can justify."

One of the moral principles discussed by several presenters at the conference was "transparency," which is very important for the industry these days. Everyone at the conference, I'm sure, would agree with EFPIA (the European Federation of Pharmaceutical Industries and Associations):  "The pharmaceutical industry recognises that it has a responsibility to show leadership in advancing responsible transparency."

The problem, I soon learned, is that transparency is good in theory, but not in practice when it comes to revealing payments to patient bloggers who "contribute" content to pharma-owned sites.

Friday, January 16, 2015

FDA Says It Will Not Regulate Low-Risk Mobile Health Apps as Medical Devices

"CDRH [FDA's Center for Devices and Radiological Health] does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act," says a new guidance posted today on the FDA website ("General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff").

Recall FDA's "Mobile medical apps Proposed Scope for Oversight" pyramid:

There are three parts of the pyramid:
  1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices. 
  2. The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion 
  3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.
The guidance released today is an attempt to define the boundary between parts 2 and 3 of the pyramid and to clarify what FDA meant in a 2012 guidance when it said this:

Thursday, January 15, 2015

"Innovative" Pharma Marketing Is Not Viral

Several recent articles and blog posts have claimed there is a lack of "Innovation" among pharma marketers who are afraid to "rock the boat."

World of DTC Marketing blogger Rich Meyer, for example, blames pharma’s “conservative” legal/regulatory people for preventing DTC marketers from being more innovative. He would like to see pharma marketers focus more on innovative digital and social media channels. But pharma marketers are afraid to do that because there is less guidance from the FDA and thus more chance that they will inadvertently run afoul of the regulators (read "2014 was a Good Year for FDA & Pharma").

Another consultant - Mark Schnurman, founding partner of Filament - writing in a MM&M article, advises agency people to "try new ideas" and "find a backdoor through which you can let your risky idea see the light of day." Mr. Schnurman cited K-Mart's viral “ship my pants” campaign as an example of a risky idea that saw the light of day and succeeded.

First of all, isn't K-Mart dead in the water? Bad case study, Mark. But there's another reason why the "ship my pants" campaign is a bad example for pharma marketers to follow and it has nothing to do with regulations.

Wednesday, January 14, 2015

LAP-BAND's Social Media Campaign Definitely Violates FDA Guidelines

I heard that a number of participants at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco were "baffled" by LAP-BAND's social media campaign. LAP-BAND, marketed by Apollo Endosurgery, is a medical device that is inserted surgically around the stomach to reduce its capacity and thus aid in weight loss.

LAP-BAND has a limited indication: "for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions." It also has a number of possible adverse events such as "band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur."

It seems that several tweets posted by the @LAPBAND Twitter account violate recent FDA "Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices" (here).

First, here's what the @LAPBAND Twitter page looks like:

Click on image for an enlarged vie.

You can SEE - but you probably can't READ - the Important Safety Information (ISI) in the upper right corner. Technically, I suppose this satisfies FDA requirements that ISI must accompany branded Rx and medical device ads that mention benefits of the product.

But it's the tweets themselves that FDA should be looking out. Let me explain why.

Friday, January 09, 2015

Are Online Peer-to-Peer Physician Discussions Overrated?

Congrats to Thibaud Guymard (@thibaudguymard), Digital Marketing Manager at MSD France, and his Comuniti team for winning the Prix Or de la Communication Médicale & Hospitalière in Paris at the yesterday.

Comuniti is a online community lunched in early 2014. It is part of MSD France's Univadis service exclusively for healthcare professionals.

"Contact your colleagues and talk exclusively with health professionals," says the Comuniti promo. "Work with your colleagues in public or private groups. Ask medical questions and find precise answers."

These capabilities offered by Comuniti are a first for Univadis, which has been around for a long time (listen to this podcast: "What is Univadis?").

Of course, it has to compete with other, similar services offered by independent companies and organizations. But MSD France hopes that Comuniti, coupled with the heaps of content available through Univadis, will be a magnet for French HCPs.

But are HCPs really interested in having discussions with their peers on so-called "peer-to-peer"  physician networks? I discussed this with Jeff Tangney, CEO & Founder, Doximity, and Shona Davies, Global Communications & Programme Leader for Univadis worldwide. You might be surprised at what they have to say about the value of online physician peer-to-peer discussions.

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