I'm at Doctors 2.0 & You Conference in Paris

Yesterday, I presented a workshop at the Doctors 2.0 & You conference in Paris. Here's a photo taken by my friend Bertalan Mesko (@berci):

You can find a link to my presentation here.

I am Off to Paris and Doctors 2.0 & You Conference!

For the next 2 weeks I will be in Europe speaking at two conferences. The first stop is Paris, France, where I will lead the "Essentials of an External Social Media Policy" workshop this Wednesday (see the meeting agenda here).

I uploaded a slide deck I prepared for that workshop on SlideShare (here). These slides present data from surveys I have done and form just the basis for beginning the discussion at the workshop. I hope the discussion and debate at my workshop helps build a concise and organized set of Fair Social Media Practice Principles that I will publish for comment after the workshop. For background and to input your own suggestions, see "Fair Social Media Practice Principles: Rules for Third-Party Engagement in Patient/Physician Social Networks."

Denise Silber (@health20Paris), Basil Strategies, is the conference organizer. She has put together quite a unique gathering, which includes a MAD (Mobile Applications Demo) Soirée! after my workshop. This party is located at Musée des Art Forains (see my Paris itinerary Google map here and below):

View Paris 2011 in a larger map

I will try and tweet from the conference (follow #doctors20 hash tag) and blog about it while I am in Paris, but I make no promises! I have a busy schedule planned sightseeing and meeting colleagues!

The Twelve Steps of Pharma Social Marketers Anonymous

Welcome to Pharma Social Marketers Anonymous (PSMA)! You are among friends.

Soon, you will take important steps on the path to overcoming your fear of social media. The first step is to admit you are powerless over social media and that your online life has become unmanageable.

Are you ready to take ALL 12 steps toward recovery?

Here are the Twelve Steps of Pharma Social Marketers Anonymous:
  1. I admitted I was powerless over social media—that my online life had become unmanageable.
  2. I came to believe that a Power greater than myself – innovative outside digital ad agencies – could restore me to sanity.
  3. I made a decision to turn my will and my online projects over to the care of the first social media agency that walked through my door and impressed me with their knowledge and experience, even if it all was with packaged goods and other lightly regulated industries.
  4. I made a searching and fearless moral inventory of my marketing practices and found they lacked social media innovation (sigh!).
  5. I admitted to my digital agency, to myself, but certainly NOT to my superiors, the exact nature of my wrong way of thinking about social media.
  6. I am entirely ready to have my digital agency remove all the defects of my character and my social media marketing plan.
  7. I humbly asked the digital agency's creative director to alleviate my social media visionary shortcomings.
  8. I made a list of all persons I had called for social media marketing advice (including Pharmaguy), DM'd them all via Twitter, and said “Nah, nah! I got an expensive agency to help me!” I also included some suggestive photos.
  9. I made these posts to such people whenever possible, and I even did it in public posts when to do so would insult them or others.
  10. I continued to take personal inventory of my social media marketing projects and when I could not prove ROI, I promptly hid that shortcoming from my superiors.
  11. I sought through public hearings at FDA and comments to the Federal Register to improve pharma's lot with the FDA as to social media marketing. I thought I understood that government agency and prayed only for knowledge of FDA’s willingness to help us and that Abrams would finally give his people the power to issue social media guidance.
  12. After having had a spiritual awakening as the result of these Steps, I carried this message to my colleagues at industry conferences, through Twitter, and at PhRMA social media "summits" urging all I met there to practice these principles -- whatever they are (I have no idea) -- in all their social media marketing affairs.
The Twelve Steps of Pharma Social Marketers Anonymous was inspired by this article ("Pharma Needs an Innovation Intervention") in BusinessWeek written by G. Michael Maddock and Raphael Louis Vitón, principals at Maddock Douglas, an ad agency that has no pharma company clients (you can't count Johnson and Johnson because they claim they are not a pharmaceutical company).

The article opens with the following AA type of rhetoric: "Are you struggling to break your addiction to a bad business model, or are you living in denial? Either way, admitting that you have a problem is the first step toward solving the problem."

[This post originally appeared in Pharma Marketing Blog
Make sure you are reading the source to get the latest comments.]

The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting

Once again the Brits have beaten the US in issuing useful guidelines for social media use by the pharmaceutical industry! As I reported back in April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published "informal guidance" providing the drug industry advice on how to use online communications (see here).

I learned today from a tweet by @dawidge (a Pfizer employee) that the ABPI Pharmacovigilance Expert Network (PEN) published GUIDANCE NOTES ON THE MANAGEMENT OF ADVERSE EVENTS AND PRODUCT COMPLAINTS FROM PHARMACEUTICAL COMPANY SPONSORED WEBSITES (find the document here).

The guidance addresses three different ways that pharmaceutical companies may learn of adverse events (AEs) through social media:
  1. "Listening in" -- Monitoring social media sites allows a company to "listen to" or "see" what the public are discussing, saying or sharing about the company itself, diseases, conditions, and treatment options.
  2. "Giving out" -- Many social media sites allow companies to initiate one-way communications to share important messages with the public, where interactive dialogue is not permitted or practical.
  3. "Engaging with" -- Engaging, exchanging and participating in interactive communication with the public. This type of activity is performed in both company and non-company sponsored sites.
I found a couple of interesting suggestions in these guidelines:

Companies Should Declare Involvement and Responsibilities
The guidelines state that "The company’s involvement in the social media site must be transparent to the users." Even when just "listening in," the company "should declare its presence by registering on the site using the company name." The ABPI concedes that "this may not be practicable or possible for buzz-monitoring type activities" that are usually carried out by third parties. "In addition," says ABPI, "it is also recommended that the company disclose the length of time it intends to sponsor the site (if known) and how it intends to screen and use any user-generated content."

ABPI also recommends that regulated companies "ensure that all staff involved in the social media channel are appropriately trained for performing pharmacovigilance related activities." That would include moderators and third-parties hired by the companies.

These are EXACTLY the kinds of disclosures from pharmaceutical companies that I suggested in a previous Pharma Marketing Blog post (see "Fair Social Media Practice Principles: Rules for Third-Party Engagement in Patient/Physician Social Networks" and respond to my survey).

Collecting AEs on Social Media Sites
ABPI recommends that company owned sites "be designed to facilitate the pharmacovigilance process" through use of "free text fields" and access to "internal/external reporting based tools which allow users to report suspected adverse drug reactions." One such tool might be a Adverse Event Reporting Widget (see "Using Social Media in a Crisis: Distribute a Product Safety Widget Is One Idea").

ABPI says that details of ALL AEs "should be collected and document, regardless of:
  • Seriousness of the event
  • Whether there is an identifiable reporter
  • Whether any adverse events are listed in the product’s Summary of Product Characteristics
  • Whether a definite causal relationship or link to the product has been stated
  • Whether the stakeholder or patient has already reported the event to the competent authority or says they have reported it to the company"
That's quite different than what commenters from the US drug industry told the FDA (see "Social Media and the Future of Adverse Event Reporting"). The US industry said such a collection regime would be too onerous.

Regarding the identity of the reporter of an AE, ABPI says an e-mail address would be considered acceptable and even a screen name would be acceptable IF the screen name allowed for contact to be made. ABPI recommends companies implement "a formal site registration process" that can be utilised to obtain information enabling regulated companies  to "identify and contact users in order to validate and follow-up on safety information." During registration, users should give consent for the company to follow-up with a user should they report AEs, says ABPI. "It should also be made clear that personal information may be processed on internal company databases and sent to regulators."

[This post originally appeared in Pharma Marketing Blog
Make sure you are reading the source to get the latest comments.]

Shaw Shtick Redemption: Michael Shaw of GSK North America Wins Title of America's Funniest Compliance Officer

Back in October, 2010, I floated the concept of Pharmaguy's Comedy Improv(e) Club, through which I hoped to highlight the humorous side of the pharmaceutical industry (see here).

Unfortunately, I didn't pursue that half-baked idea and somebody beat me to it!

In today's Wall Street Journal I read that Michael Shaw, Vice President and Chief Compliance Officer, North America Pharmaceuticals at GlaxoSmithKline, won the title of the nation's funniest compliance officer (read more about it here).

Here's a bit of Shaw's Shtick:
"I know what you think when you hear compliance officer," said Mr. Shaw at the beginning of his act. "Dynamic, charismatic, well-dressed, gets into all the clubs, has to beat off women—and men—with a stick."
Then he went into character, as an overwrought guy who sees risk everywhere, until he's pushed near his breaking point.
"But heavy is the head that wears the crown!" he said, his voice rising: "Day in, day out, my job…is to find risk, to understand the problems associated with that risk, and to find solutions."
Mr. Shaw, a tall, clean-cut man, leaned forward, his face reddening, veins in his neck bulging: "Risk, problem, solution! Risk, problem, solution! All day, every day, every situation!" he screamed.
Shaw won his title during a recent competition at New York's Comic Strip comedy club. The competition was  organized by executives at Howard-Sloan, a headhunting firm in New York. The event raised over $11,000 for juvenile diabetes research.

Congratulations to Michael Shaw! You have redeemed the pharmaceutical industry by demonstrating the human side of the business!

[This post originally appeared in Pharma Marketing Blog
Make sure you are reading the source to get the latest comments.]

Academic Physicians Promulgate "Principles of Conservative Prescribing" to Limit Patient Exposure to Drug Risks

A shift toward more conservative medication-prescribing practices would serve patients better and counterbalance prescribing pressures from the drug industry, according to a review article published Online First today by Archives of Internal Medicine, one of the JAMA/Archives journals. The article is part of the journal’s Less Is More series.

The authors argue that physicians -- especially young physicians, "who lack historical knowledge of past drug harms and withdrawals from the market" -- should resist the urge to prescribe the "latest and greatest" drugs, a tendency, say the authors, that is "congruent with the messages and interests of the pharmaceutical industry."

The proposed "Principles of Conservative Prescribing" address practically every tactic the pharmaceutical industry uses to increase prescriptions including, Direct-to-Consumer (DTC) advertising, sales rep distribution of peer-reviewed literature to physicians (which the FDA allows), off-label promotion of drugs (which is illegal, but often done by pharmaceutical companies who are sometimes caught doing it!), pharma-sponsored CME or education from "'experts' with conflicts of interest," using surrogate endpoints rather than outcomes to measure clinical trial success, etc.

With regard to DTC advertising, for example, the authors obviously believe that "with the growth of direct-to-consumer advertising, clinicians are under greater pressure from their patients to prescribe advertised drugs." The authors warn physicians not to take the "path of least resistance." To which I have two comments: (1) the path of least resistance is also the path to profits, whereas the other path leads to bankruptcy, and (2) the authors obviously have not heard that DTC advertising has been proved NOT to influence physician prescribing (see "Advertisers Don't Know How DTC Works. Say wha?").

Here's the abstract that summarizes all the principles:
Judicious prescribing is a prerequisite for safe and appropriate medication use. Based on evidence and lessons from recent studies demonstrating problems with widely prescribed medications, we offer a series of principles as a prescription for more cautious and conservative prescribing. These principles urge clinicians to (1) think beyond drugs (consider nondrug therapy, treatable underlying causes, and prevention); (2) practice more strategic prescribing (defer nonurgent drug treatment; avoid unwarranted drug switching; be circumspect about unproven drug uses; and start treatment with only 1 new drug at a time); (3) maintain heightened vigilance regarding adverse effects (suspect drug reactions; be aware of withdrawal syndromes; and educate patients to anticipate reactions); (4) exercise caution and skepticism regarding new drugs (seek out unbiased information; wait until drugs have sufficient time on the market; be skeptical about surrogate rather than true clinical outcomes; avoid stretching indications; avoid seduction by elegant molecular pharmacology; beware of selective drug trial reporting); (5) work with patients for a shared agenda (do not automatically accede to drug requests; consider nonadherence before adding drugs to regimen; avoid restarting previously unsuccessful drug treatment; discontinue treatment with unneeded medications; and respect patients’ reservations about drugs); and (6) consider long-term, broader impacts (weigh long-term outcomes, and recognize that improved systems may outweigh marginal benefits of new drugs). [Arch Intern Med. 2011;10.1001/archinternmed.2011.256.]
I doubt if a young physician just starting private practice could build a financially successful practice based on these principles, which are specifically designed as tricks for new dogs. These physicians have to compete with the old dogs out there who have been weaned by the drug industry to expect the industry to pay for everything in return for which they will prescribe their drugs -- especially new, unproven in the real world drugs.

The authors, in fact, recommend that physicians obey the "7-year rule" when prescribing; ie, "wait 7 years before using a new drug." Wholly cow! The authors cite a couple of studies purporting to show that "it often takes 5 to 10 years to identify significant adverse effects."

Adverse effects figure large in the Principles. I would go so far as to say that adverse drug effects form the principles' principal target! Maybe it is just a coincidence that recently I came across news reports that adverse drug events are one of the leading causes of death in the U.S. and other developed countries around the world.

At one point, the authors ask "Could 'fibromyalgia' pain be statin-induced myopathy?" [authors' quotes, not mine, around fibromyalgia]. This prompted my own question: Is it just a coincidence that Pfizer, which produces Lipitor, the #1 selling statin, is also aggressively marketing Lyrica for the treatment of fibromyalgia pain? Coincidentally, a few days ago the FDA recommended changes in the Zocor (another statin drug) label (see "FDA approves redesigned labels for some Merck drugs"). The mind boggles!

The authors advise physicians not to ignore any problem that develops while a patient is taking a medication, "no matter how unusual or unlikely a symptom a patient reports... always consider that it might be drug related."

I am sure the drug industry will have something to say about that!

[This post originally appeared in Pharma Marketing Blog. Make sure you are reading the source to get the latest comments.]

Majority of Bad Ad Complaints Submitted by Pharma "Representatives" Deemed Worthy of "Comprehensive Review" by FDA

According to a Bad Ad Program 2010-2011 Year End Report just issued by the FDA (see here), the program is a success despite the fact that ONLY 125 complaints were deemed worthy of "comprehensive review." The remaining 203 Bad Ad complaints were presumably filed away in DDMAC's circular file. Those 125 complaints worthy enough for review lead to 5 enforcement actions.

The agency "does not view the total number of reports, or number of enforcement actions taken as the primary measures for program success," said FDA in the report. "Instead, FDA’s most important measure of success for this program is the heightened sense of awareness of misleading promotion among HCPs throughout the health care community and the likely useful deterrent this awareness has on drug promoters who might run afoul of regulation absent of such messaging."

FDA received complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see chart below; click for enlarged view).

FDA says that the quality of complaints submitted by HCPs "demonstrates a relatively strong level of knowledge in the medical community about what constitutes misleading promotion." Since pharma's complaints were even MORE credible than those from HCPs, FDA should have said it "demonstrates a relatively strong level of knowledge in the PHARMA community about what constitutes misleading promotion."

It's not clear, however, if "representatives of regulated industry" include HCPs employed by pharma companies. At least one recipient of an FDA Bad Ad enforcement letter claimed the complaint came from such as source (see "Competitors Are "Best Source" of Complaints About Promotions Received by FDA").

[This post originally appeared in Pharma Marketing Blog. Make sure you are reading the source to get the latest comments.]

Fair Social Media Practice Principles: Rules for Third-Party Engagement in Patient/Physician Social Networks

Recently, there's been some discussion on Twitter and certain blogs about Sermo, the online physician community based in the U.S. When Sermo representative Thomas Rines (@tomrines) tweeted that "Sermo is an online community for US physicians. We provide our clients the ability to engage with the community" in a recent #MedDevice chat, he caused a "What? Wait!" doubletake (see "The Twitter Chat that Killed Sermo").

It seems that many physicians -- including some who are Sermo members -- are not aware of Sermo's business model, which is “Sermo is free to practicing physicians. Revenue is generated as healthcare institutions, financial services firms and government agencies purchase Sermo products to access this elite group of practitioners.”

Here were some responses to Rines' tweet:
"Sounds like @SermoTeam is willing to host docs for free in order to gather info and push products for $"

"Do docs really know their conversations are being mined?"

"I doubt docs know exactly how Sermo mines their conversations."

"Seems many topics of late come back to transparency & the motives for not being transparent."

"May be a blog post to be had from this."
The last two comments are relevant to why I am writing this blog post.

Before I proceed, you should know that Sermo is a client of mine. I recently helped them promote their services to the subscribers of Pharma Marketing News, most of whom are interested in accessing Sermo's  elite group of practitioners (see the message I sent out to subscribers here: "Get $3,000 of Market Research, FREE"). I've also had a conversation with Daniel Palestrant, Founder and CEO of Sermo, about how pharmaceutical companies can interact with Sermo members (listen to the podcast: "Pharma, Physicians, and Sermo: A Social Media Win-Win-Win!").

I have also wondered how happy Sermo physicians are with its policy and whether or not a majority of them approve of it (see "Pfizer has a Gold Mine in Sermo!").

Given all the publicity and transparency about Sermo's business model, I am surprised to see comments like the ones above and this one by "SteveBMD," author of blog "Thought Broadcast," who said (see "Discussing social media with physicians on Sermo"):
"Sermo is not a physician-only community," says SteveBMD.
"Sermo generates revenue by selling access to its site to “healthcare institutions, financial services firms and government agencies.” See this link on their site: http://sermo.com/client/research/overview
"Unfortunately, this is not made clear to doctors when they sign up or participate. Instead, doctors are led to believe that this is like an “online doctors’ lounge.” A better description would be a doctors lounge with insurance companies, pharma companies, market researchers, and government agencies peeking through the window."
I am not a physician, so I cannot join Sermo and look at exactly what Sermo leads doctors to believe when and after they join. But I do know that Sermo has a 4,278 word "Terms of Use" document that it links to right on the Sign Up page (see below; click for an enlarged view).

This is a typical legal agreement that most of us see on Web sites, but automatically FAIL to read! If you want to become a member, you MUST agree. But what exactly are Sermo members agreeing to?

The Sermo Terms of Use document gets to the point of this blog in ITEM #7, which explains "Hotspots", which are "visual indicators within the Site that enable Sermo and its clients to present opportunities ('Opportunities') for interaction with You." Further down in ITEM #16, Sermo explains that "any material, information or other communication You transmit or post to the Site or third party site will be considered non-confidential and non-proprietary" and "Sermo and its designees will be free to use for any purpose, copy, disclose, sell, distribute, perform, incorporate and otherwise use the Communications and all data, images, sounds, text, and other things embodied therein for any and all commercial or non-commercial purposes to the extent permitted by applicable law."

OK, so Sermo DOES explain its business plan in its Terms of Use.

I question whether this is ENOUGH, considering that most everyone ignores these documents written in legalese -- a language that repulses many of us ordinary folk, including doctors!

Instead, owners and operators of online discussion sites -- whether they be independent corporations such as Sermo, or hospitals, other healthcare organizations, and even pharmaceutical companies (someday) -- should publish SOCIAL MEDIA POLICIES that are separate and different from their Terms of Use agreements.

A Social Media Policy is not just an agreement that users must abide by. More importantly, it is a PROMISE to users from site owners/sponsors concerning how they will protect or attempt to protect user-generated content, personal conversations, interactions, and engagements with third-parties on the site. The policy should also explain how users should "behave" on the site (eg, "rules of engagement").

Fair Social Media Practice Principles
It used to be that privacy policies were written in legalese incorporated into terms of use agreements. Even when separate privacy policies were developed, they varied from site to site owned and run by the same organization. After government (ie, FTC) privacy policy guidelines and laws were enacted, privacy policies were required to comply with standard fair information practice principles that make certain promises about protecting a user's privacy (see, for example, "Pharmaceutical Compliance with Fair Information Practice Principles"). Privacy policies also have become much easier to read and understand.

The same should be true of the social media policies I am talking about. I hope, however, this is done on a voluntary basis by the industry rather than by new laws.

Therefore, in summary, I propose that owners and operators of online discussion sites -- whether they be independent corporations such as Sermo, or hospitals, other healthcare organizations, and even pharmaceutical companies (someday) -- publish SOCIAL MEDIA POLICIES that comply with as-yet-to-be-determined "fair social media practice principles."

But what are the essential elements of "Fair Social Media Practice Principles?"

That's the question I plan to address at a June 22, 2011 workshop in Paris at the Doctor's 2.0 & You conference. Find my workshop on the agenda here.

Some ideas for essential social media good practice principles include:
  • A comment moderation policy that explains how discussions are reviewed before or after publication
  • Qualifications for discussion moderators, if there are moderators
  • How site moderators are trained regarding policies
  • Rules for participation in discussions by site owner employees
  • Rules for participation by third-party sponsors, clients or their agents
  • How "misinformation" is defined and what the policy is for correcting such information
What do you think? Please give me your input on  this by responding to my Rules for Pharma Engagement in Patient/Physician Social Networks survey. It will only take 5 minutes. I promise that when I get back from Paris, I will write up what I learned from this survey and from workshop participants in Pharma Marketing News. Your responses can be confidential (ie, anonymous) or you can opt in to being cited in the article should I publish your comments.

First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information

Yesterday, my post "FDA Drops Social Media from Its 2011 Guidance Agenda" (here) created quite a stir on Twitter. We had a good discussion of this on last nights #socpharm chat.

All the hubbub revolved around the fact that FDA's 2011 guidance agenda did NOT include "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda. What IS included in the 2011 agenda, however, is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet."

I didn't understand what "Responding to Unsolicited Requests" had to do with social media and technically, FDA's 2011 guidance agenda does NOT mention social media, hence the title of my blog post.

Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC, however, seemed to insist that FDA was still committed to develop guidance for social media, but offered no specific details.

Looking back at FDA's Federal Register notice regarding its November, 2009 Public Hearing (see here), I find absolutely no mention of "unsolicited" ANYTHING, including no mention of "unsolicited requests for Prescription Drug and Medical Device Information."

So, why did the FDA put "Responding to Unsolicited Requests" at the TOP of its list of "issues related to Internet/social media promotion of FDA-regulated medical products" for which it promises to issue guidance in 2011? Where did that issue arise? It wasn't mentioned in the Federal Register, as I said.

So, I decided to look in the transcripts of the Public Hearing and found ONLY one mention of "unsolicited" and it was in the November 12, 2009, presentation made by Mark Gaydos, Senior Director of U.S. Regulatory Affairs, Marketed Products at sanofi-aventis. Gaydos spoke on behalf of the Social Media Working Group, which included representatives from Amgen, AstraZeneca, Bristol-Myers Squibb, Millennium Pharmaceuticals, and sanofi-aventis U.S. He spoke specifically about practical approaches for the pharmaceutical industry's "engagement in online communities or social media in a compliant manner."

Gaydos envisioned "specific scenarios where we're talking about unsolicited questions that are posed on a company-sponsored site." One specific scenario involved questions about "off-label" use of a company's drug. Gaydos said, "with off-label questions there is already an accepted way for companies to in a compliant fashion respond to those questions," but "It's difficult to apply the same criteria here with the off-label statements."

Gaydos imagined the following scenario: "You can imagine, for instance, someone visits a company site, and there's a community hosted on that site, and they mention, oh, I'm taking your product for a specific condition, and that happens to be an off-label use of the product. However, it may have been deemed medically appropriate by their physician. Imagine how you would feel if you did something like that, and you were told by a company, that's an inappropriate use of our product, when, in fact, the doctor said it is appropriate." That could harm the patient-physician relationship, said Gaydos.

So here we have a social media scenario put forward by a coalition of pharma companies for which the FDA might issue guidance in 2011. And that's what FDA means by "Responding to Unsolicited Requests" (more accurately, "unsolicited statements").

Listen to my February, 2010, Pharma Marketing Talk interview of members of the Social Media Working Group (click the play button in the widget below):

NOTE: Facebook's NEW comment policy may also be a motivating factor. See "New Facebook Policy "Kind of Hurts" Pharma Marketers"

FDA Drops Social Media from Its 2011 Guidance Agenda

I just downloaded the "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2011" from the FDA site (find it here).

Missing from this agenda is "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda (see here).

However, included in the 2011 agenda under the Advertising Category is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet." Is this supposed to be the promised guidance we've all been waiting for? "Responding to unsolicited requests" is NOT a social media issue nor was it one of the questions FDA asked at the November 2009, public hearing (see all the questions here).

I don't know who/what to believe. In February, 2011, Tom Abrams, Head of DDMAC, said "We want to have these [social media] guidances out as soon as possible" (see here). FDA set the end of the first quarter of 2011 as the deadline goal. It missed that goal and hasn't set a new one. Now I see that the 2011 Guidance Agenda doesn't even include social media guidance.

I don't think the FDA is being very transparent and is sending the industry conflicting signals. What do you think?

P.S. See "Breaking – Its Official – FDA Delaying Social Media Guidance Until at Least Q1 2011" which highlighted email from the FDA that had "Responding to unsolicited requests" at the top of the list of social media issues the FDA is researching for draft guidance.

Although social media and the Internet expose pharma companies to unsolicited requests (ie, when they allow comments on Facebook or follow people on Twitter) it is NOT an issue that was discussed at the November, 2009 Public Hearing nor in the comments submitted to the FDA regarding social media.

[I stand corrected. The issue of how to respond to "unsolicited statements" about off-label use of drugs on pharma-owned social media sites WAS discussed at the hearing. See  see "First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information"]

Writing guidance for handling unsolicited requests is a no-brainer compared to developing guidance on how pharma marketers can comply with FDA regulations when space is limited as in search engine ads and tweets. Why isn't the FDA tackling THAT all-important social media issue first? After all, those infamous 14 NOV letters were all about that and NOT about handling unsolicited requests. For my answer to that mystery, see "FDA, DOJ, & Google: Conspiracy Theory, Part 2."

P.P.S. I called and e-mailed Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC. Here's the response I received from her via e-mail:
Hi John,

Thanks for your voicemail and e-mail messages. You should have received an autoreply e-mail from this account with the current status of our policy and guidance development on Internet/social media promotion, which is an Agency-wide effort that involves an extensive work and review process. While "Responding to unsolicited requests..." is listed by name on the 2011 CDER Guidance Agenda, it is only one of multiple topics for which we plan to issue draft guidances. At this point I cannot provide any specific timeframes due to our GGPs as many parties are involved, not just DDMAC. Please know that we are committed to moving forward with policy development in this important area by issuing well-vetted and meaningful draft guidances!


P.P.P.S. For a follow up, see "First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information".