Monday, February 17, 2014

2014: The Year for FDA Guidance on Social Media

Many in the pharma industry have been anxiously awaiting social media guidance from FDA. Going all the way back to November 2009, FDA has repeatedly promised to provide more clarity around how it intends to regulate pharmaceutical promotion within dynamic environments such as Web pages and social media.

Folks, if we choose to believe its true, 2014 looks to be the year that FDA will deliver on those promises.

In December 2011, FDA issued draft guidance for responding to unsolicited requests for off-label information. Then this January, they released draft guidance on 2253/2301 submissions of social/user-generated content. The document focused on the protocol for submitting form 2253/2301 for both owned and third-party user-generated or “realtime” content. But it also revealed what the FDA considers its regulatory domain and illuminates what the FDA is most concerned about enforcing in this arena. It also helped explain when manufacturers are responsible or accountable for promotional content, taking into consideration the source of the content and the level of influence/control.

Now we’ve learned from RAPS that CDER has published its guidance agenda for 2014, and on the agenda are three additional social media-related documents:
  • Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
  • Internet/Social Media Platforms: Correcting Independent-Third Party Misinformation About Prescription Drugs and Medical Devices
  • Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links

As a reminder, the five questions to which FDA asked the industry to respond during the November 2009 Part 15 hearing included:
  1. Accountability. For what online communications are manufacturers, packers, or distributors accountable?
  2. Space limitations. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
  3. Correcting 3rd-party information. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
  4. When is the use of links appropriate?
  5. AE reporting. Questions specific to Internet adverse event reporting

Let's look at those questions again and the progress against them:

What happened to guidance on AE reporting? I'm not sure, and it's interesting because -- right or wrong -- AE reporting responsibilities tend to be one of the biggest red flags to pharma companies looking to participate in social media.

AE's aside - according to multiple reports and if we choose to believe it is true – it looks like in 2014 FDA will fulfill the hopes and dreams of pharma marketers everywhere and make participating on social media crystal clear.

Then again, maybe we shouldn’t believe everything we read on the Internet.

Wednesday, January 15, 2014

FDA Draft Guidance Opens Up Social Options for Pharma

In language that you and I can better understand, that means FDA is seeking to answer some of the industry's social media questions such as, "What are the expectations around the frequency of submission of a dynamic page – such as a Twitter account or a blog that hosts commenting – to FDA?” “What triggers a 2253 when it comes to social media?” “How do I report if a representative of my company posted a comment on someone elses’ site? Should that trigger a 2253?”

While the FDA hasn't said a whole lot about it, the industry is already abuzz.

Here's why:  Though it is currently "draft" guidance, it does have implications for how pharma and animal health companies engage in and report their social media promotional activity. So if you are a pharma marketer who is currently using social media for your brand -- or is thinking about doing so soon -- you should be paying attention.

To be clear, the document is not comprehensive “social media guidance,” rather, it is another in a series of guidance documents following the 2009 hearing addressing the ever-changing world of digital and social communications.  According to the FDA web site, FDA is developing a variety of guidance concepts, including:
“… how companies should respond to unsolicited requests for information about off-label use, issues with space limitations, fulfilling post-marketing submission requirements, accountability, use of links on the Internet, and how sponsors should correct misinformation about their products disseminated by third parties.”
Pharmaceutical and animal health companies who are already active in social media will appreciate FDA providing clarity on some topics, such as clarification that FDA won’t hold companies responsible for truly independent user-generated content, even on a company’s own channel. Companies who have been cautious and/or are awaiting guidance will appreciate what is likely just one more in a series of draft guidance documents laying out the FDA’s thinking on the topic.

By way of quick summary, the draft guidance document:

  • Recognizes the challenges of submitting promotional materials that display “real-time” information, such as user-generated content (UGC).
  • Recognizes that there is a difference in interactive, dynamic content vs. static content, and that it may make sense for postmarketing submissions of these types of content to be handled differently.
  • Lays out FDA’s thinking on the difference between company-controlled and independently-generated content, and where these types of content fall within FDA’s regulatory purview.
  •  Provides recommendations for how to properly submit and/or resubmit promotional materials that include UGC using Form 2253 (human health) or 2301 (animal health)  in situations such as:
    • A company-owned product website includes a “real-time” dynamic component such as a blog.
    • An employee or designated agent (agency, KOL, paid blogger) of the company posts on behalf of the company to a third-party Web site.
  • Applies to branded promotional materials regardless of the target audience (consumer, HCP, other).
  •  Provides a number of helpful examples, similar to what was seen in recent mobile guidance.

Intouch Solutions will be publishing our formal POV publicly very soon. [*UPDATE: We published it here.]

I am confident this is just the start of one of the more interesting conversations around regulation of social media for some time!

I, for one, am excited.

Tuesday, December 17, 2013

Let's Give Our Friends at Med Ad News a Proper Send-off

I was shocked and sad to learn that industry publication Med Ad News will no longer exist. The publisher recently sent this email to customers:

December 13, 2013

RE: Closure of MedAdNews/Pharmalive/Pharmalot/eKnowledgeBase/R&D

Dear Valued Customer,
I am writing to inform you that we have taken the decision to cease producing the MedAdNews/Pharmalive/Pharmalot/eKnowledgeBase and R&D Directions brands. This is effective 12/31/13.
We want to express our deep gratitude for your business and support that has played such an important part over the last thirty years.

I am sure you will also join us in thanking the team that has diligently produced the brands. We wish them well in the future.
All products including the December issue of MedAdNews and all digital newsletters will be produced and distributed as normal until 12/31/13. They will be billed as normal. You will not be billed for any commitments you have made beyond 12/31/13.

Until 12/31/13, please contact us as normal. From 1/1/14 onwards, please contact Efrain Garcia with any billing questions. We wish you every success in the future.


Stephen Corrick

So Med Ad News is closing its doors for good. The publication that, for 31 years, has provided balanced, ethical, professional reporting on the pharmaceutical industry. The publication that gave us PharmaLot and PharmaLive. That challenged industry practices by asking tough questions. That provided valuable insights into pharma business and marketing strategies. And also paused to celebrate industry successes with the annual Manny Awards.

Perhaps it's yet another sign of the times of the changing publishing industry. Perhaps it's a big mistake by UBM Canon. Whatever the reason, Med Ad News and the people behind it will be sorely missed. These are smart, talented people. They know the pharma industry better than many of us.

They will all land somewhere solid, possibly better off than they were before.

But it didn’t seem right to just let them fade quietly into the sunset. So I wanted to offer up a forum for giving our friends a proper send-off. Using the comments section below, won’t you join me in wishing them well?

It’s the least we could do for a team that gave us so much for so many years.

Monday, July 1, 2013

What Every Pharma Procurement Group Needs: A "Rogue Agency" Roster

I read with interest the report in the June issue of MM&M, "Healthcare Marketers Trend Report 2013." The report benchmarks and analyzes topics that affect pharma marketers such as budgets, channel mix, perceived challenges, and more. One area that resonated with me was the one on how pharma companies choose their marketing/agency partners. The findings show that the larger the pharma organization, the more likely they are to use procurement services and preferred partner lists.

In my experience, procurement or purchasing organizations limit the number of agencies within their organization and partner up with traditional networks for (perceived) cost savings. In reality, I'm not sure I hear often that those cost savings played out as reality. And the limitations might be hurting those company's ability to partner with more specialized agencies with a mind for innovation.

"I do think the procurement pendulum has swung a little too far in the big companies," one consultant was quoted as saying. "To me, you see a lot of the more innovative stuff in the smaller companies, so you have to ask: 'Is procurement inhibiting innovation?'"

Being on the front lines of the agency side of partner searches, I’ve been hearing a few trends of my own lately:
  • “We have contracts with networks. But we need more innovative thinking. So we’re maintaining a roster of agencies outside of that list.” – Top 10 pharma
  • “We have plenty of holding company agencies we work with. But our sense is there are likely some more interesting and more innovative agencies out there … independent and outside of those networks.” – Agency search consultant on behalf of a top 20 pharma
  • “I’m looking for a pharma-focused digital agency with a strength in social media.” – Top 10 pharm
  • “My more traditional/branding agencies are adding digital capabilities, so lately they’ve been pushing to do our digital work. But what we’re learning is that they don’t know it as well as they say they do. Things are breaking. And they’re still not staying on top of the changing landscape.” – Mid-size pharma
  • "My AOR is handling my digital work. I'm afraid we're missing major opportunities because digital/social/mobile is not their strength." - Top 20 pharma
  • “I need someone to help up our game in social media. My current agencies just aren’t cutting it. And they’re really expensive.” – Mid-size pharma

If you’re a pharma brand manager and these challenges sound familiar, rest assured you’re not alone.

So is procucrement inhibiting innovation? If they are, it doesn't have to be that way.

Pharma procurement departments and the marketers they serve can have the best of both worlds. If they must do contracts with large holding company networks and they feel that works for them, great. But if they then feel they aren't quite getting what they need, or if they fear they are missing out on opportunities to innovate, procurement groups can easily set up a roster of agencies outside of that network. These may be the smaller, independent, more nimble agencies that look at things a little differently. Call it a "rogue roster," an "innovation agency list," or "preferred partner" list ... whatever you call it, it can be a source of new ideas and new ways of looking at things.

This month (July) marks my 10th year in digital marketing, and I’ve certainly seen a lot change. But one thing that hasn’t changed is that there continues to be a need for highly specialized firms that not only understand pharma marketing, they look at it through a digital lens. They understand the importance of the digital channel and all its capabilities. And they have a drive to stay ahead of the technology curve and continue to innovate on behalf of the industry.

Agency relationships can be complicated. To be fair, I also still hear from brand managers who would rather manage just one agency, and they’d rather that agency’s strength be branding. Or they feel that the digital work that their traditional network agency is doing is “good enough” for what they are trying to accomplish. And that’s okay. Sometimes the right agency setup depends on your own comfort level as well as partnerships with long-trusted partners.

I’ve heard some people say “digital marketing will cease to be digital marketing … it will just be 'marketing.'" And same with social. And same with mobile. But I dare to disagree. These channels are more highly specialized and rapidly evolving than any channel before them. They demand a new level of attention, appreciation and understanding. And often, not just any old agency will do.

Tuesday, May 28, 2013

FDA Reprimands First Mobile App

In a first last week, FDA issued a warning to developers of a mobile healthcare app.

In an “It Has Come to Our Attention Letter”* issued to India-based Biosense Technologies, FDA voiced its concerns around the uChek Urine Analyzer app and invited the company to discuss the topic further.

(*It probably “came to their attention” from hype delivered via TED Talk and subsequent Mashable article, “This App Will Test Your Pee,” from February of this year. Also, according to MobiHealthNews, the app was mentioned as an example of one that FDA is failing to regulate during recent congressional hearings.)

The uChek app is designed to help patients read reagent strips (manufactured by Siemens and Bayer) for urinalysis, including, according to the FDA letter, “glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.” In a nutshell, the uChek app allows users to analyze their urinalysis dipsticks at home via mobile phone.

But FDA felt that the app (and in fact the entire system) should be classified as a device because, while Siemens’ and Bayer’s urinalysis dipsticks are cleared by FDA, analyzing them via mobile app is not.

FDA issued draft guidance in 2011 around mobile medical applications. This is the first direct citation of a mobile medical app since then.

Stifling Innovation Through Regulation?

This article from Libertarian publication Reason Magazine felt the citation is an example of FDA stifling innovation through regulation.

But I’m not sure I agree.

I don’t know much about Biosense or their clinical rigors. I expect they made attempts to make the app as safe and as accurate as possible. And according to the uChek website, they’ve been successful in gaining attention from BBC, Wired, TechCruch, CNET, and more.

But does that mean the app is accurate? That there’s little chance for error?

Who knows? And that’s exactly FDA’s point.

I doubt Seimens nor Bayer endorsed the app to be used with their strips. I do know the pharma/healthcare industry has a poor enough reputation without being associated with rogue mobile apps that could cause patients harm. Time will tell if Biosense decides to go through with a 510(k) submission.

Yes, the FDA 510(k) submission approval process adds layers of complexity and cost to development of apps for use by patients or professionals. By design, it is the most stringent type of device marketing application required by FDA.

But if it’s truly an innovative app that fills a need and will be valuable to patients, the effort of 510(k) clearance will be worth it. And if the FDA review process helps ensure patients stay safe while using FDA-cleared mobile apps, bring it on. In fact, they should consider some kind of Good Housekeeping-esuqe FDA seal of approval.

In the words of Myshkin Ingawale, co-founder of Biosense Technologies, "Everybody pees, and everybody carries a cellphone.”

In the words of FDA (not really) …. “Everyone is making mobile apps, and everyone must make sure they are safe.”
Additional background and perspective:

Wednesday, March 13, 2013

Pharma: Where Innovation Comes with an *Asterisk

All the buzz from SXSW Interactive this week -- plus this NPR article about Facebook COO Sheryl Sandberg -- got me thinking about innovation in the pharma industry.

Per the article, apparently there are posters around Facebook's headquarters that encourage employees to get things done. To take risk. To fail:

"Move Fast and Break Things"

"Done Is Better Than Perfect"

"Fail Harder"

"What Would You Do If You Weren't Afraid?"

One may have questions about if these mantras have really worked for Facebook as a company.

But I love the spirit of them, and the idea of them plastered around the walls as motivation. As an agency whose motivation IS innovation, I can see how these daily reminders help drive people to think differently. To ask the tough questions. To steadily, relentlessly seek solutions. Even if it means bucking the status quo.

Which got me thinking about the inherent dichotomy of innovation and the pharma industry.
  • Imagine if, while composing an NDA submission for a major new compound, the submission team took the approach of “done is better than perfect.”
  • What if a rogue marketer decided “to hell with FDA regulations” and instructed his promotional team to “move fast and break things.”
  • Are pharma CEOs – nervous about what healthcare reform could mean to their bottom lines – telling their companies to “fail harder?” I think not.
But we have seen innovation happen in the industry. We have seen changes taking place. Even failures in the industry are a step forward, because from those failures come information and learnings. We live in a modern society, after all, with life-saving medications that would not have come to fruition if not for countless failures in the labs.

I encourage you all to keep moving. To take risk. To fail harder and faster.

Within the pharma industry, for better or worse, these mantras come with an asterisk:
* Innovation must not come at the risk of patient safety.
* Innovation must not come at the risk of corporate responsibility or ethics

Did I miss any?

Facebook is one thing. Human health is another. But I choose to live in a world where I believe  innovation is possible anywhere.