Blaming the FDA for Pharma's Tepid Use of Social Media

A tweet by Paul Tunnah (@pharmaphorum) caught my attention this morning:

"…the FDA social media regulations for pharma marketing are extremely strict…" bit.ly/NaPU7h #pharma #socialmedia

This linked to a blog post "Social media challenges and benefits for pharmaceutical companies" by Rodica Ceslov, president of Wild Frog Studio, "a dynamic full-service firm helping companies create go-to-market strategies and execute product launches for new products, new product line extensions and re-packaging existing products."

The full quote from Ceslov is "the FDA social media regulations for pharma marketing are extremely strict, and at the same time still somewhat ambiguous, lacking clear structural boundaries that are needed to prevent unwarranted issues."

How can FDA social media regulations be "extremely strict" when there are NO such regulations (ambiguous or otherwise)?

What the drug industry is looking for is "guidance" regarding how the FDA will interpret existing regulations, which are media agnostic. Even if FDA does issue such guidance, it is not legally binding. Some pharma companies -- eg, Pfizer -- are looking for new regulations, which would be legally-binding (read "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

So, it's more a matter of how pharma INTERPRETS existing regulations without guidance from the FDA. Some pharma companies are more comfortable than others when it comes to doing this as they launch social media marketing campaigns. Pfizer even claims to have a "Social Media Playbook" (read "Is This Pfizer's Social Media 'Playbook?'")

So far, however, no pharma social media communication/campaign has been cited by the FDA for violating any regulations unless the communication overstates efficacy or understates risks (ie, says things that are against regulations no matter what the medium).

The FDA has come out with guidance on responding to unsolicited requests, which include guidance on how to handle off-label drug information requests via social media such as YouTube and blogs (read "FDA Guidance on Responding to Unsolicited Requests for Off-Label Infnrmation Via Social Media").

This guidance is actually neither very strict nor very ambiguous. So stop blaming the FDA for preventing pharma companies from using social media!

P.S. Ms. Ceslov works for an agency that obviously wants more pharma clients. Her blog post promotes a "3 Step eBook" called "How to Succeed in Social Media." My advice to pharma on how to succeed in social media is this: pick your outside agencies with care. For more on that, read "PR vs Interactive: Agencies Vie for Pharma Social Media Campaign Crumbs."

The 3rd Annual Pharmaguy Social Media Pioneer Award

If you are a regular reader of Pharma Marketing Blog, you know that I generally do not like awards sponsored by pharma trade publications (see “Awards. What Are They Good For?”). Such awards are somewhat suspect because of the inherent conflicts of interests involved -- the winners tend to be the agencies that advertise the most in the sponsoring publication or that purchase big page ads announcing that they won the award.

The Pharmaguy Social Media Pioneer Award
Defenders of pharma “social media” site awards insist that we must reward even the most elementary attempts that pharma is making to have online conversations despite all the regulatory obstacles that they face. I agree. But instead of having awards for the work product, why not give awards to the pioneers who have lead the way to create these sites? We can learn more from how these pioneers overcame the obstacles to launch a social media project than from the end result – even if the end result is flawed or faux.

Sometimes, pioneers work "behind the scenes," making it possible for their colleagues to develop customer-facing social media projects. We must recognize these efforts as well. Marketing campaigns and Web sites come and go, but pioneers move on to new positions and continue to spread their influence far and wide.

To better recognize the value of these pioneers, I launched the Pharmaguy Social Media Pioneer Award in July, 2010. The first award went to Alex Butler (see here) and the second award went to Tony Jewell (see here).

The Pharmaguy Social Media Pioneer Award is meant to recognize pioneers who work (or have recently worked) within regulated drug and device companies. The award recognizes courage in the face of regulatory and corporate culture boundaries!

What's With the Hawaiian Shirt?
Let me explain the Hawaiian shirt motif of the award. Around the time that the FDA announced it would hold a public hearing regarding regulation of pharma’s use of the Internet and social media, I started appearing at conferences in a yellow Hawaiian shirt, which was left over from a Hunter S. Thompson Halloween costume (see “Pharma Social Media Crips vs. Legal/Regulatory Bloods: Call for a ‘Peace’ Conference” for a sighting of me in the shirt at the 3rd Annual Digital Pharma East Conference). I also considered wearing the shirt when I made my presentation to the FDA at the November, 2009 meeting (see “Fear and Loathing in Washington, DC”), but out of respect for the FDA and the audience, I opted for a traditional suit and tie.

Although I didn’t wear my Hawaiian shirt at the FDA hearing, it became an emblem for standing out from the crowd, which is a necessary trait for a social media marketing pioneer. I think a Hawaiian shirt motif befits, therefore, what the Pharmaguy Pharma Social Media Pioneer Award stands for.

The Nominees Are…
I have several people in mind as contenders for this award (see the end of this post), but first let me discuss what I consider to be the qualifications for nominees.

What are the qualifications to be nominated to receive this prestigious award?

First, a nominee must work or have worked within an FDA-regulated pharmaceutical, medical device, or biotech company when he or she pioneered in social media marketing or non-branded communications or was an advocate for such. Although there are many people in agencies that are true social media pioneers and who have been involved in many pharma social media projects, only the insider has the experience and courage I am looking for. The insider has to contend with many stakeholders inside the organization and is ultimately responsible for the project. Consultants and agencies do not have nearly as much skin in the game as do insiders.

Although some pharma social media pioneers have subsequently moved on to other positions in non-pharma companies (see, for example, "Is There an Upward Career Path Within Pharma for Social Media Pioneers?"), they are still eligible for consideration as nominees for the Pharmaguy Social Media Pioneer Award.

Second, a nominee must have been a true social media pioneer. By that I mean someone who has been involved from the early days in marshaling the forces necessary to ultimately build a social media campaign. No matter if the campaign has been a failure. We often learn more from our failures than from our successes. Above all, we want nominees who have learned and who can share their learnings with us.

Third, although it is not necessary that a nominee to have experienced a “Mack Attack” such as that experienced by Novo Nordisk’s Ambre Morley (see “Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!”), it can’t hurt, especially if that person has survived and gone on to be interviewed by me (eg, “Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter”).

The type of social media that a nominee has been involved with is immaterial as long as it is one or more of the following: a blog, a Twitter account, a Facebook page, a network (community), a YouTube channel, etc.

That’s about it for qualifications.

Who Will Nominate Candidates and Determine Who Wins an Award?
Since this award has my Twitter name associated with it, I take ultimate responsibility for who to consider for this award and who wins an award. I already have several candidates in mind (see below).

However, I also depend upon my readers and colleagues to assist me. You can vote for my nominations and write-in other candidates using the online form here (sorry, voting is closed; see a summary of the results here). Not only your vote, but the comments you add will go a long way awards influencing me, especially if you offer details that back up your choices. I especially need help identifying former pharma people who may be working at agencies, but who did a lot of their social media pioneering while employed at a pharmaceutical company.

Ultimately, I will use my best judgment and experience to decide who is qualified to enter the contest and who wins an award. My decision is final.

NOTE: It occurs to me that many pharma marketing initiatives – including social media initiatives – are the result of teamwork within the organization. For example, a SM Pioneer may operate behind the scenes to support a pioneering product manager who makes the decision. Both are pioneers and should be rewarded. It is possible, therefore, that several people may share the same award. I also recognize the fact that outside consultants and agencies may have played a critical role. When appropriate, these pioneers will also receive honorable mention when the awards are announced.

Let me start the process by nominating several people that I know and have interacted with listed in alphabetically by last name. You can click on each name to learn more about this person and add comments. More names will be added as the nominations continue. Please add your nominations and/or votes here.

Nominees
For the most up-to-date list, see Nominees for The Pharmaguy Social Media Award.

NOTE: Every nominee for the Pharmaguy Social Media Pioneer Award is a winner and deserves recognition. But only 1 individual will be awarded the coveted Hawaiian shirt. This is NOT a popularity contest. "Winners" will be chosen solely by Pharmaguy (me) based on my evaluation of merit. Your votes, however, will also count to influence my decision. Also, I need your comments about the people you nominate so that I can profile each and every nominee in recognition of his or her pioneering effort.

Positive or Not, Pediatric Drug Trials Pay Off: Cymbalta and Oxycontin Case Studies

Very few people may know that drug companies can get an additional six months of market exclusivity from FDA as an inducement for them to study the efficacy and safety of drugs in children. Fewer people realize that no matter what the outcome of such tests, FDA will still grant the additional 6 months of exclusivity before generic copies of the tested drug can be introduced.

A case in point is Cymbalta, an antidepressant marketed by Lilly.

As reported in the Wall Street Journal (here), Cymbalta will have an additional six months of U.S. market exclusivity -- through December 2013 -- because the company studied the drug's effects on children. "Lilly said, however, that it won't seek regulatory approval to market Cymbalta for pediatric use because study results were inconclusive regarding Cymbalta's efficacy in children."

Cymbalta is the "duct tape" of drugs; i.e., it has many approved indications for use in adults.

Cymbalta was originally approved in 2004 for adults with major depression. Later the FDA granted Lilly approval to market Cymbalta for treating nerve pain in diabetics, GAD (ie, "generalized anxiety disorder"; see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!") and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain.

With each new indication comes the potential to increase sales significantly. In 2010, for example, Cymbalta was approved for chronic lower back and knee pain, an indication that may have increased sales by $500 Million, a 16% increase over the $3.07 Bn in sales for Cymbalta in 2009 (read, for example, "Cymbalta: A Sweet ROI for Chronic Pain Indication").

But a 16% increase in sales is paltry compared with a 50% increase in sales that is possible when the FDA approves a drug for use in children under the Best Pharmaceuticals for Children Act, a statute that created the incentive for drug makers to test the products in young patients. For Lilly, a 6-month extension of market exclusivity for Cymbalta could give Lilly more than a $2 Billion windfall (in April, 2012, Lilly reported that first-quarter sales of Cymbalta rose 23% to $1.11 billion).

I'm sure the intent of the law was to make it possible for physicians to prescribe drugs for children based on evidence that the drugs worked in children. To offset the cost to drug companies to run trails to prove efficacy, Congress allowed 6 months of additional exclusivity during which those costs could be recouped. In the case of Cymbalta, children do not benefit and Lilly more than recoups the cost of pediatric trials, which involve perhaps only a few hundred subjects.

Purdue Pharma, however, claimed it lacked resources in 2004 when it abandoned a pediatric Oxycontin clinical trial requested by the FDA. Only now -- when Oxycontin is a mere year away from losing market exclusivity -- is Purdue pursing such a trial (see "After Delay, OxyContin’s Use in Young Is Under Study"). Sales of Oxycontin reached $1.7 billion (in the U.S.?) in 2004.

It is too soon to know if the Oxycontin pediatric trial will demonstrate any effectiveness in treating children under 12. One thing that is certain, however, is that street use of Oxycontin by children and young adults is deadly. If extended market exclusivity can help prevent illegal diversion of even cheaper generic versions of Oxycontin, then I am all for it no matter what the clinical trail results!

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