A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

If you think waiting over two years for FDA to issue guidelines it promised for regulation of "Promotion of Prescription Drug Products Using Social Media Tools," then you should take a look at the following timeline and weep.

This timeline documents the major steps in FDA's process of developing guidance for direct to consumer television (DTC) and radio ads; ie, "standards that would be considered in determining whether the major statement in direct-to-consumer television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner":

• 1 November 2005: FDA convenes a 2-day public hearing to discuss the issue (see "FDA DTC Hearings: Snippets from Day 1" and "DTC Pros and Cons Presented at Public Hearing"). Sound familiar?


• 21 August 2007: FDA announces it will conduct a study of "consumer evaluations of variations in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." It opens a 90-day period to submit comments regarding this study. This study used the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. I suggested FDA NOT use Chinese characters because that would be discriminatory, but they did not listen to me (see "FDA at a Mall Near You: The Manchurian Connection"). With regard to social media guidelines, the FDA has also announced it will do some studies before issuing guidance (see "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"). Deja vu all over again!


• 29 March 2010: FDA finally publishes the draft guidance, more than 4 years after the public hearing (see Federal register ref: 75 FR 15376). FDA was goosed along by an act of Congress: the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA was forced into RULEMAKING mode rather than GUIDANCE mode, which is how the pharma industry wants the agency to approach the regulation social media drug promotion as well (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").


• June 2011: FDA published an executive summary of a study of the methodology of the AMP study cited above entitled "A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure" (find it here). Maybe FDA read my comments after all!


• 27 January 2012: FDA announced that it added a document to the docket for the proposed rulemaking concerning a study entitled: "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study; see Docket No. FDA–2009–N–0582). This document reopened the comment period (extending the deadline to February 27, 2012) for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards. Way back during the public hearing in 2005 I was unimpressed by research claiming that TV drug ads were designed to "distract" viewers from reading the fair balance (see op cit and "Ruth Day and the Bees Repeat Performance at House DTC Hearing" for an update on that).


• 23 March 2012: FDA reopens the comment period for a second time "in response to a request for more time to submit comments to the Agency." The new comment period will expire on April 9, 2012. According to the FDA, the "Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a letter dated February 20, 2012, requesting an additional 15 days for interested persons to comment. FDA believes that an additional 15 days to comment on the Distraction Study as it relates to the proposed standards is appropriate."

What strikes me are the similarities between the evolution of these DTC guidelines/rules and the long-awaited social media guidelines.

First, there are the delaying studies and studies of studies. It's well-known that if you wish to halt progress, do a study.

Second, I sense that the drug industry pushed the FDA into RULEMAKING rather than issuing guidelines although it took an act of Congress to do that in this case. The drug industry may use the courts in the case of social media (another example of how an "activist" judiciary can work both sides of the aisle).

If it takes the FDA SEVEN or more years to complete this process for TV ads, I imagine it will take them 10 years to finalize guidance or rules (whatever!) for regulation of the use of social media for drug promotion. While TV has more or less stagnated during the seven years since 2005, social media will look completely different by the time those 10 years are up in 2019!

Taking the "Cool" Way Out of Having Rx Product Convos on Social Media

I have criticized pharma companies for mentioning Rx brand product names via social media. Mostly because they forget to include fair balance or don't educate the public (see, for example, "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!").

That doesn't mean, however, that I don't believe there is a way for pharma to engage in branded product discussions via social media such as Twitter and Facebook (see, for example, "Breaking the 140-character Limit of Twitter Opens the Door to FDA-Compliant Branded Tweets").

It appears that most pharma companies have decided not to engage in these kinds of discussions and are implying that FDA regulations prevent them from doing so.

Take for example a discussion about Paula Deen on the Novo Nordisk Facebook wall (here) . Amidst the criticisms and defenses of Novo was this statement by "Tanya", a representative of Novo Nordisk:

"Hi Darcy, I had to remove your post becuase (sic) you mention a product name, which we are not allowed to have on our page - even if you post it yourself. Can you repost without mentioning the product name? Sorry! -- Tanya"

Unfortunately, I can't see what product was mentioned because the post was deleted. Duh! However, it was probably Victoza -- the diabetes product that pays for the endorsement by Paula Deen.

I infer from Tanya's statement that there is some FDA law or regulation against mentioning product names on the Novo FB page. In fact, there is no such law or regulation. And in other "social media" contexts -- such as my BlogTalkRadio show -- Ambre Morley, Associate Director, Product Communications, Novo Nordisk, didn't seem to have any problem mentioning the product name. In fact, she didn't point out the possible side effects (fair balance). I'm not sure if she broke the law there or not (you can read a summary of that discussion here; use code '1111nvd' to get it free; or listen to the podcast here).

Are pharmaceutical companies missing an opportunity to educate people about their products by "handling" posts as Novo did in the above example?

Some people actually think this policy of removing posts that mention products is a good thing. Idil Cakim, for example, said "the Novo Nordisk community manager 'played it cool' by only reminding the fans of the FDA guidelines" (see "Novo Nordisk Handles Paula Deen Reactions on Facebook").

I should have put a "sic" next to "FDA guidelines" because there are NONE! Tanya only reminded people what Novo Nordisk's POLICY is. [To be more clear, Tanya SHOULD have said "it is our policy not to mention product names."] I guess Idil -- one of "the world's best social media thinkers" featured on socialmediatoday.com -- also inferred from Tanya's statement that there was a LAW or guidelines.

There are, in fact, some new FDA guidelines for dealing with certain branded communications on social media (see "Review of The Social Media Guidelines Nobody Expected!"). These guidelines only apply to "off-label" discussions on social media sites. I don't know if these guidelines were applicable in this case.

Tanya may have "played it cool," but she missed an opportunity to really inform her FB visitors about Victoza, assuming that was the product mentioned in the deleted post.

But without more encompassing FDA social media guidelines, every pharma company will just continue to take the easy "cool" way out and censor any mention of product names on its social media sites.

P.S. Dear Novo Nordisk: Sorry that I seem to be focusing on you these past couple of weeks! But you ARE in the news a lot these days. I'm not sure it's helping or hurting the sales of Victoza because you don't mention the drug much in public statements about Paula Deen or on your Facebook page. That's fine. Just so you know. I'm not picking on you exclusively. I've gone on posting binges against Pfizer, Boehringer-Ingelheim, and practically every other pharma company. So, please don't take it personally.

FDA Social Media Guidelines May Be Moot If This Court Decision Holds Up

Drugmakers dissatisfied with the FDA’s use of guidances as a form of policymaking -- including long-awaited guidance for use of social media by the pharmaceutical industry -- could find legal ammunition against the practice in the case "United States of America v. Franck’s Lab," which is pending appeal in the U.S. Court of Appeals for the Eleventh Circuit.

I noted before that the drug industry may be arraying its legal forces to derail the issuance of social media guideline (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media" and "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing").

The ruling being appealed is that FDA does not have authority to enjoin the "long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances." What can this possibly have to do with social media guidances?

According to a recent Washington Legal Foundation (WLF) "Backgrounder" (see "Court Ruling - If Upheld - Casts Doubt on FDA's Use of Guidance Documents"), "While Franck's case involved pharmacy compounding of bulk pharmaceuticals in non-food producing animals, its implications extend broadly to other areas of FDA law, particularly as it relates to FDA’s increasing use of guidance documents to expand regulatory requirements. In the past year, FDA has issued dozens of important draft guidance documents and final guidance documents, while releasing very few significant regulations. Given FDA’s penchant for issuing guidance documents instead of proceeding through notice and comment rulemaking, the court’s decision may have broad applicability concerning FDA’s ability to regulate or enforce its laws through guidance instead of rules. Indeed, FDA often applies draft guidance documents as if they represented binding obligations. It sometimes even references the contents of the document in communications with industry before the document is finalized."

WLF points out another reason the drug industry prefers rulemaking over guidance: "When FDA issues guidance documents," says WLF, "it tends not to acknowledge the negative comments. The agency typically offers no explanation for why it has opted to stick with its proposed language, rather than making changes to address adverse comments. This failure to respond to comments is not permitted for agencies when they engage in rulemaking [my emphasis]."

This lack of response to comments is a significant factor for social media guidance. The FDA held a public hearing and requested comments on the social media regulatory issues it proposed to write guidance for. Many, many comments were submitted (see "Answers to FDA's Questions Regarding Pharma's Use of Social Media") and so far the FDA has remained mum regarding these comments and may even do so when -- and if -- it publishes more social media guidelines. The recent off-label guidance (see "FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media") also did not refer to any comments the agency may have received.

"If the district court's ruling is upheld," says WLF, "its analysis on FDA’s use of guidance documents is likely to be cited in other FDA proceedings and legal challenges testing the agency’s right to enforce through guidance in lieu of regulations."

P.S. I note that the court case in question involved the death of several ponies due to a compounding error! PONIES! Lucky that it wasn't PEOPLE because I'm sure the court would not be so callous as to strike down FDA's rights in that case.

[Hat Tip to Darshan Kulkarni (see @FDALawyers and website) for providing information about this case.]

FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media

Yesterday, while most of us were still on vacation, the FDA quietly issued without fanfare -- ie, no press release telling us about it or how to submit comments -- "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." You can find the document here.

Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet. While this may not be the "social media" guidance many people were expecting (see "First FDA Social Media Guidance to Address Responding to 'Unsolicited Requests' for Off-label Information"), it does include guidelines for responding to unsolicited requests for off-label information encountered through "emerging electronic media."

As with all guidances, FDA warns "Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use." Some drug companies (eg, Pfizer) would have preferred new legally-binding regulations rather than guidelines (see, for example, "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). The industry might also challenge these guidelines on legal grounds (see, for example, "Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing").

Aside from pressure by the drug industry, FDA felt the need to issue this guidance because it "recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products." I'm not sure I agree with that because there have been a number of surveys that indicate physicians (as well as the general public) have several other preferred sources of drug information (see, for example, "Are Pharma Reps Important to Docs or Not?"). But let's leave that issue aside for now.

Let's take a closer look at how these guidelines apply to social media such as Youtube, Blogs, and Twitter.

The guidelines break out responding to PRIVATE and PUBLIC requests for off-label information. As for handling private requests, the guidelines pretty much reiterate what the drug industry already knows. The section regarding public requests, however, is what will be of most interest to the industry. Social media is in the this category.

Youtube and Solicited Requests
The guidelines have something interesting to say about videos posted on Youtube.  Specifically, it warns about responding to public comments that may be received in response to videos that a pharma company may encourage people to post about about their own uses of the company's product. FDA gives this example:

"A firm asks or otherwise encourages users to post videos about their own uses of its product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s 1encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests."

FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited. If a company responds to such "solicited  requests," it must be careful because such responses  "may be used as evidence of a new intended use. Introducing a product into commerce for such a new intended use without FDA approval or clearance would, under these requirements, generally violate the law."

Is this guidance enough to encourage pharma companies to open up comments on their Youtube pages?

I doubt it. Most pharma companies are still waiting to know how they should respond to potential adverse event reports they may receive via comments before they venture into opening up comments on Youtube. It's not even likely that pharma companies will engage in branded Youtube projects in the first place, although there has been a precedent (see "Novartis Attempts Perfect Execution of Web 2.0 Trick!").

Of more interest to me are the examples FDA gives for how drug companies should respond to "unsolicited" requests via social media.

Blogger Example of "Solicited Request"
FDA cites this example: "If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the product’s off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests."

Although I have never heard of a pharma company ever "encouraging" bloggers to write about off-label uses, I do know that some companies have invited bloggers to vacation sites (see "A Call for Pharma Social Media Transparency Guidelines for Patient Bloggers"). What they discuss behind closed doors is not known to me or to the FDA unless there is a blogger "mole" present.

So, how would FDA prove that the company "encouraged" off-label discussion?

One way is to examine the contents of the "packets of information" sent to the bloggers. If that packet includes off-label information, then FDA can make a case that the company encouraged the blogger to write about it.  (See "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons" for a similar situation involving BI). The guidelines do NOT get into this level of detail, which is unfortunate and supports industry's claim that FDA guidance is often "unclear." I'm sure this will be a topic covered by comments to the FDA regarding this guidance.

Twitter Example of "Solicited Request"
FDA cites this example: "If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited requests."

Many pharma company Twitter accounts have been used to announce results of studies related to unapproved uses of Rx drugs. Some such tweets may have made efficacy claims, but I am not aware of any that claimed the product was "safe." I am not sure from reading the guidelines how FDA would view such tweets.

How should pharma respond to unsolicited requests received via public Internet sites and social media?

FDA puts limits on how to respond to such requests on public sites. FDA is concerned that product information "posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time [and] that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available)."

In general, FDA's position is that "a firm’s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information."

That eliminates a "loop hole" I often worried about; namely, an anonymous agent of a pharmaceutical company can post a request for off-label information and initiate a discussion that includes information posted by the pharmaceutical company itself.

FDA suggests that a drug company handle such public requests through private channels after the requester follows up to the contact provided with a private request that will then be handled "offline."

FDA says:

• The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information. 
• The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

Does It Serve the Public Interest?
Regarding responding to public requests; eg, via social media, FDA says "any substantive communication about off-label uses for the product, in response to the original unsolicited off label question, should occur solely between the firm and the individual who made the request," says FDA. "Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum."

Unfortunately, although this may close the "loop hole" I mentioned above, this method of responding individually has a couple of negative implications:

1. First, private responses may not serve "the best interest of public health" because "public" means a bunch of people, not one person at a time. On the one hand, FDA believes responding to unsolicited requests for information about off label uses of the firm’s products serves the public interest because the firm has "robust and current information about their products." On the other hand, firms cannot distribute this information "publicly."
2. Responding privately requires more resources and expenses. Many people over the course of time may have the same questions. Instead of being able to use the power of the Internet to answer all these questions in a single message, each must be handled separately.

Sales and Marketing May be Seen, but Should NOT Be Heard From!
However the response is made, the FDA believes that "Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments. FDA recommends that medical or scientific personnel have specialized backgrounds in responding to unsolicited requests for information, including important training, such as appropriately narrowing questions, tailoring responses only to the specific questions being asked, providing unbiased responses, and properly documenting responses.

"By contrast," says FDA, "because sales and marketing personnel are focused by training and experience on promoting a firm’s products, FDA recommends that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information."

There are more nuggets of information in this guidance that I haven't covered here. I look forward to the comments form the drug industry itself.

Webicina's "Open Access" Social Media Guidelines for Pharma

Health Social Media advocates abhor a vacuum, especially when the vacuum is caused by the lack of FDA guidelines for use of social media by the pharmaceutical industry. To fill that vacuum, several more or less independent 3rd parties are developing guidelines for the industry in the hopes of spurring the FDA to eventually do the same or to bypass the new for FDA guidelines altogether.

In the U.S., the Digital Health Coalition (DHC) is in the final stages of developing its "Social Guiding Principles," which is being shared with members of PhRMA who have expressed interest in the project. DHC's 7 dwarf-sized principles have been making the rounds to a select group of insiders and will be made public at the ePharma Summit in NYC this February (perhaps on my birthday!). See the PMN Conference Calendar for a link to the summit.

Another 3rd-party (ie. Peter Pitts) version of social media principles for pharma was previously reviewed by me (see "Deconstructing Pitts' Guiding Principles for Pharma Social Media"). Pitts created 11 principles. However, many of these principles may be very similar to the DHC ones if only because Peter Pitts worked with DHC.

Just recently, a third set of 3rd-party social media principles was released by my friend Dr. Bertalan Mesko (better known as @Berci), the founder and managing director of Webicina.com. These "open access" social media guidelines for pharma, which you can find here, were written by an adhoc editorial board of social media advocates with suggestions from "hundreds of collaborators." The authors are @Berci, Dr. Felix Jackson (@felixjackson), Silja Chouquet (@whydotpharma), Andrew Spong (@andrewspong), Denise Silber (@health20paris), and Rob Halkes (@rohal). It is a distinctly European group of experts, who hope their effort will "facilitate the process for the FDA of publishing its own guide."

Unfortunately, I don't think the FDA will be looking to an "open access" document for ideas. Also, in my opinion the "open access" SM guidelines, like the other two 3rd-party documents mentioned above, are much too vague to be of any use to the FDA. Still, I'd like to review the Webicina guidelines and see how they might be used by the pharmaceutical industry.

The Webicina document breaks down the guidelines into the following 8 categories:

1. A Physician’s Rules of Engagement 
2. Pharma’s Rules of Engagement 
3. How pharma should use social media 
4. How pharma should use Wikipedia 
5. How pharma should use Facebook 
6. How pharma should use Twitter 
7. How pharma should write blogs 
8. How pharma should use Youtube

Obviously, a lot of these "How To's" -- such as "speak plainly" and "be helpful" -- are not in FDA's bailiwick or not specific enough for FDA regulatory guidelines. I'll just look at what I think are the most interesting aspects of these guidelines, whether or not they are useful to the FDA.

Can Social Media Replace Face-to-Face Sales Rep and Physician Contact?
Under "Pharma’s Rules of Engagement," is included a few guidelines on how pharma should interact with medical professionals. It states, for example, "A private social media message is often as good as a face to face talk." In this context, I assume "face to face talk" means a visit by a pharmaceutical sales rep. Of course, personal contact between people will never be completely replaced by social media contact, but I can see how social media can save time and money if sales reps could communicate with physicians other than via office visits, which are pretty limited in the EU compared to the U.S.

But should pharma sales reps have their own Twitter accounts and should physicians "follow" these accounts and vice versa so that reps can DM (direct message) their physician clients? Maybe it would work. I'm sure that physicians would prefer short 140-character Twitter DMs over long email blasts! And these days, much commercial email ends up in the spam folder never to be opened!

People to People, Not Company to People Communication
Another suggestion put forward in this document is that when pharma companies use social media, they should "Be human. Ensure that you engage with people as people." I am an advocate of that idea and have been trying to "out" the humans who are working in pharma and who are using Twitter (see "More Pharma Social Media Pioneers Recognized"). But many pharma social media activities are completely non-personal and try to use the brand or company name as something real people will communicate with! It's not always easy to see who is "behind the curtain" and posting tweets or comments on Facebook. Sometimes, phony people are used to make the conversation seem more personal (see, for example, "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). That, of course, violates the main principle mentioned again and again in the Webicina document "Be transparent. Clearly state who you are and what your intent is."

For Facebook, the Webicina guidelines state: "Be clear: Provide information about the company with contact details and clearly state who publishes comments on behalf of the company. People prefer talking with a real person, not a brand or a company."

I see a problem with pharma companies getting too personal and allowing the person behind the curtain to be too visible. First, some companies (eg, Pfizer) claim that they do not have any people (FTEs) dedicated to social media. Several people may share the responsibility of posting tweets, for example. People also leave one company and join another. Nevertheless, I have given my Pharmaguy Social Media Pioneer Award to real people behind the curtain, not the company (see, for example, "AZ's Tony Jewell Receives 2nd Annual Pharmaguy Social Media Pioneer Award"). I just hope that it helps them when they look for a job with a competitor's company :-)!

Enable Comments, Don't Moderate?
The issue of comments on pharma social media sites is very problematic for the industry, which often cites regulations for why comments are turned off on sites like YouTube and until recently on Facebook. We've seen a number of instances where a pharma company has gotten in trouble because of  comments (most notably on Facebook; see, for example, ' "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page").

The Webicina guidelines, however, prefer that comments be enabled "where possible" (whatever that means). Furthermore, this principle of avoiding comment moderation is reiterated several times in the guidelines: "Avoid moderation. If you have to moderate, try not to pre-moderate and clearly state what you will moderate and why. Publish your moderation policy."

Pre-moderation, which the Webicina guidelines say may be OK fo blogs, is probably not something many pharma companies have the resources for managing. It may be something that is outsourced, though. Right now, however, it is an extra-added expense that many companies do not wish to have. Several comments form the industry to FDA's call for answers to its questions about social media favor post-moderation over pre-moderation (see "Answers to FDA's Questions Regarding Pharma's Use of Social Media").

Another, related principle: "Avoid editing comments. Do not edit the comments you moderate as it changes the meaning. People don’t like this. Remove the comment and explain why." This was another topic covered in comments to the FDA (op cit). It took less than 48 hours for Pfizer to explain why it deleted certain comments on its Chapstick FB page (see "Pfizer's Facebook Fiasco: Chapstick Slapstick Ad Uses Woman's Ass as a Prop"). That wasn't fast enough, however, to prevent a social media "death spiral" as reported by AdWeek.

Stop When Finished. Is a Campaign Socially Acceptable?
One interesting principle espoused by the Webicina guidelines is "Stop when finished. Close finished campaigns and redirect people to other places." In some pharma pundit circles, mentioning "campaign" and "social media" in the same sentence is as taboo as saying social media is "just another channel." Recently, I've criticized some pharma companies for abandoning their Facebook "friends" when new rules about comments were put in place (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?").

I can see why pharma marketers prefer a campaign with a beginning and an end. They have specific budgets and must achieve a specific measurable goal (e.g, increased market share) within a certain time frame. There are other patient and physician needs that pharma can meet via social media that are NOT compatible with such a campaign mentality. Needs such as how to find affordable medicines, how to get more information about adhering to the treatment and other support issues. It's not clear who within a pharmaceutical company is charged with meeting such needs or if there is a budget outside control of the brand team for such things.

Wikipedia Editing Rules
On at least one occasion, a pharmaceutical company was caught editing a Wikipedia page about one of its products in order to gloss over some negative studies (see "Web 2.0 Pharma Marketing Tricks for Dummies"). @berci is an expert regarding publishing health information on Wikipedia, so I would take his advice (as it appears in the Webicina guidelines) seriously.

One Wikipedia editing guideline suggested is this: "Do not promote. Do not edit an article to promote your medicine." It may not be so easy to determine if the edit was done to help promote the product or to "correct misinformation." One person's idea of "misinformation" may differ from another person's -- especially if the other person is a marketer. Selectively adding only positive information (eg, positive results from new clinical trials) can be considered promotion -- in fact, it's what PR people (who are the pharma people in charge of social media activities) do all the time to "promote" their products.

Webicina offers a better Wikipedia editing principle for pharma: "Suggest edits. Suggest edits on the Discussion page for other editors to make. But you still need to be transparent about who you are and explain your rationale."

Rules for Twitter
Webicina et al have a couple of interesting rules for how pharma companies should use Twitter.

"Select your audience. Use different accounts for different audiences so that people can follow content which is tailored and appropriate for them. Examples include investors, shareholders, journalists, job seekers, patients and customers."

I haven't seen many pharma companies with multiple Twitter accounts, although I am sure there are a few. Some companies (e.g., Pfizer) may have different Twitter accounts in different countries. But most pharma Twitter accounts are corporate communications accounts that push out information to all the above-mentioned audiences in all countries. I haven't seen any that are just for patients, for example.

"Publish more than 140 chars. Use longer messages with services like Twitlonger to include additional information."

This is a good idea and one that I suggested some time ago (see "Breaking the 140-character Limit of Twitter Opens the Door to FDA-Compliant Branded Tweets"). I pointed out that this technique can allow pharmaceutical companies to make branded Tweets that will pass muster with the FDA. The "additional information" could be used to mention the brand name as well the important side effects as required by the FDA. However, I don't see this technique being widely adopted by any of the people or companies I follow on Twitter. I don't even bother with it myself.

You're Mad if You Don't Use Youtube
That's what the authors of the Webicina social media guidelines think, mostly because Youtube "generates the world's second largest number of searches after Google itself." Of course, that has nothing whatsoever to do with the merits of Youtube as a social media platform/channel or whatever. I have often said that pharma's interest in social media such as Facebook and Youtube has more to do with search engine visibility than with engaging in conversations (see "Drug Companies Are Flocking to Facebook for Eyeballs, Not Conversation").

It doesn't take a genius (or guidelines) to understand the appeal of Facebook, Youtube, and other social media platforms. This is where the "eyeballs" are as demonstrated by this chart from the 2011 PwC Health Research Institute Survey (click on the chart for an enlarged view):

I'm not surprised by the percent of consumers who have used Facebook, Youtube, and blogs to get health information, but I am bewildered by the "fact" that more people have used Google+ than Twitter for this purpose. I thought Google+ was dead in the water as a useful social media alternative to Facebook or Twitter. It could be that people chose Google+ meaning Google search because the latter was not an option in the survey. But I can see it now! There will be a rush to Google+ by pharma marketers in order to get in on the ground floor of another social media eyeball fest! In fact, I have heard that some companies are reserving Google+ account names without yet having any specific plans for how they will use it!

If FDA Published Social Media Guidelines as a Facebook Page, PhRMA Would "Like" It!

PhRMA -- the US pharmaceutical trade association -- just now published an oblique critique of the FDA for fiddling with issuing its promised social media guidelines while pharma Facebook pages burn in response to new commenting policies (see "What We'd "Like": FDA's Social Media Guidance").

"After all," said PhRMA's Kate Connors, "the FDA is quite active online, with Facebook and several Twitter accounts. Our companies aim to be able to be just as engaged in discussions about health and science as the agency that regulates them, because we thoroughly believe that better information can ultimately lead to better health. To that end, we continue to wait for FDA’s guidance, and to hope that it comes soon."

Whoa! FDA you've just been "bitch-slapped" by PhRMA!

FDA Issues Long-Awaited Guidance - for Mobile Medical Apps. Janssen, Look Out!

While one arm of the FDA -- the Division of Drug Marketing, Advertising, and Communications (DDMAC), the arm responsible for regulating drug promotion -- is dragging its feet issuing guidance for social media promotion (first promised for 2010, now completely off the 2011 guidance calendar; see "FDA Drops Social Media from Its 2011 Guidance Agenda"), two other arms -- the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER); responsible for regulating medical devices -- has issued guidance for mobile medical applications (see "FDA outlines oversight of mobile medical applications" where you can download the guidance document).

The guidance focuses only on a select group of applications and goes out of its way to assure the public that the FDA "will not regulate the sale or general consumer use of smartphones or tablets."

As you know, there are probably thousands of consumer-focused health apps available for smartphones. The guidance carves most of these out of its regulatory bailiwick. According to the guidance, the following represents mobile apps that FDA does NOT consider to be mobile medical apps for purposes of the guidance:

"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition [my emphasis]. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."

I highlighted the wording that determines whether or not FDA might consider health apps subject to being regulated as medical devices: "not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition."

The guidance defines what would make an app a mobile medical app subject to regulation as:

"When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device."

"One example," says the FDA, "is a light emitting diode (LED) included on a mobile platform with a mobile app to make that LED operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific device intended use), neither the mobile app nor the mobile platform would be considered medical devices. If, however, through marketing and distribution, the mobile app is promoted by the manufacturer for use as a light source to examine patients, then the mobile app would meet the definition of a device. (In this case, the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.)"

Are there any pharma developed and promoted mobile apps that fit this definition and thereby SHOULD be regulated as a medical mobile app?

YES, THERE IS!

Back in March, I suggested that Janssen's "Psoriasis" app for the iPhone and iPad may be a candidate for regulation as a medical device. You can read all about that in this blog post: "FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It" and in this Pharma Marketing News article: "Pharma SmartPhone/Tablet Apps. Is There a Regulation for That?"

One of the questions I had about Janssen's Psoriasis app concerned the accuracy of the formula used to calculate PASI ("Psoriasis Area and Severity Index"), which is a tool for the measurement of severity of psoriasis. The app is intended for physicians to use in diagnosing their patients. Suppose there was a "bug" in the program that calculated the PASI score? It seems that such software needs to be regulated as a medical device by the FDA.

In fact, I notice that there is an update available for Janssen's Psoriasis app. It was issued on 31 May 2011, about a month and a half after I blogged about the app. The note relating to the update merely states "bug fix." Could there have been a "bug" -- ie, ERROR -- in the formula used?

I updated my iPhone version of Janssen's Psoriasis app, but I do not notice any difference in the app nor the instructions that come with it. The "bug fix," therefore, could actually involve the software that calculates PASI.

Regardless of whether such pharma apps may be regulated by FDA as medical devices, I strongly believe that developers of health-related apps should explain in detail what "bugs" were fixed so that users have an idea of how the "bug" may have affected them. Shame on Janssen for not being more transparent in this regard!

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

PhRMA Statement on FDA Social Media Guidance Delay

By now everyone is aware that the FDA has missed its SECOND deadline for issuing some form of guidance to the drug industry for the promotion of Rx products via the Internet and specifically via social media (see, for example, "No News is No News – DDMAC Fails to Produce Guidance").

Of course, further delay in issuing such guidance is very frustrating for the dozens of stakeholders who the FDA invited in November 2009 to make presentations at a public hearing.

To highlight that frustration, on April 1, 2011 (April Fools Day), I created a bogus PhRMA Statement, which included these memorable lines:

"Due to FDA’s limited resources and an increasing workload, FDA should seek out help developing social media guidance. PhRMA intends to continue to serve as a constructive partner in that regard. So why not give us a call or tweet us? We’ll be happy to draft some guidelines tout de suite."

and

“FDA says it wants the draft guidances ‘well thought out’ when they are issued. I mean, how difficult can it be? PhRMA Intern will be returning after the Spring semester is over and we can assign her to the project."

and

“FDA’s failure to act in this matter is a slap in the face of the pharmaceutical industry, which urgently requires social media guidance. ‘Let's Build Something Together’ is a famous tag line from Lowe’s Home Improvement. That sums up our position with regard to building FDA social media guidance as well."

The joke was successful as far as April Fools go and PhRMA had to act fast to contain the media's confusion. Christian Clymer (@CCatPhRMA), Social Media Lead for PhRMA, tweeted this in response to my post:

"Have you been fooled? See @pharmaguy April Fool's joke and PhRMA's real statement here... http://bit.ly/gEqjyz"

The link in his post leads to another note on PhRMA's blog:

April Facts v. April Fool's

by Kate Connors on 4/1/2011

Perhaps you’ve seen John Mack’s April Fool’s post that says he’s gotten a copy of PhRMA’s “statement” on the Food and Drug Administration’s delayed social media guidelines.

Mack’s post, which presents a fictitious statement, has made the rounds this morning, underscoring the immediacy of social media.

Here is our actual statement, released yesterday.

Go ahead and read PhRMA's ACTUAL statement. I think if PhRMA allowed itself to speak frankly, the real PhRMA Statement would have closely resembled my April Fools version. Now that April Fool's is over, I have removed the fake statement from this blog. See you NEXT April 1!

Scrooge FDA Delays Laying Social Media Guidelines Golden Egg: Why?

FDA's DDMAC is playing Scrooge to the drug industry's Tiny Tim this Christmas season and -- to mix metaphors -- won't be laying the golden goose egg everyone was expecting in 2010. The egg of which I am speaking, of course, is guidance for drug promotion via the Internet and social media.

According to a post over at EyeOnFDA, DDMAC issued this statement:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• On-line communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

I am not sure where this statement was made or to whom exactly, but I'll take it at face value.

This delay does not bode well for all of us expecting action from the FDA. With the new, Republican-controlled Congress coming into session next year, "Lame Duck" (or Cooked Goose) FDA officials are likely to be summoned before Senate and House committees to testify and to be grilled by Republicans. FDA may have to defend a lot of its recent regulatory actions. Obviously, Republicans favor less regulation and not more regulation. This may set the atmosphere within the FDA to be less vigilant regarding the regulation of drug advertising in general and Internet advertising in particular.

Also, political battles are likely to rage during the next Congress regarding recent online privacy initiatives by the FTC and the White House. The FDA may be caught up in these battles and be forced to be more cautious about issuing Internet guidelines. The announced delay may even be the first sign of caution. I note that the Center for Digital Democracy, for example, said FDA was incapable of policing privacy issues related to online health marketing (see "New Media Privacy Issues & Online Health Marketing").

AMA Policy on Use of Social Media Sees the Glass Half Empty

Yesterday, the American Medical Association (AMA) adopted a new policy on "Professionalism in the Use of Social Media" (find the press release here) According to the AMA, this policy aims at "helping physicians to maintain a positive online presence and preserve the integrity of the patient-physician relationship."

Looking over the AMA guidelines,  I find that this policy, like all such policies -- including the policies of pharma companies regarding employee use of social media -- (1) was developed after the cow has left the barn (ie, many physicians are already using social media; see, for example, this recent Pharma Marketing News article: "Physician-Generated Content on Social Media Sites") and (2) has an underlying negative view of social media and physician-generated content.

The last principle, for example, states:

"Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession."

A recent survey of physicians (see here) using social networks performed by DocCheck -- a major European physician portal and social network -- asked "Have you ever read and learned important medical information from content posted by other healthcare professionals on DocCheck, or on a similar online healthcare professional network?" Sixty-three percent (63%) said "Yes" (see chart below). Obviously, the majority of physicians learn from “physician-generated content” posted on social networks like DocCheck.

Another AMA social media principle states:

"When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities."

What "authorities" does the AMA have in mind? The AMA? I see this as a slippery slope.

Its interesting that "dialogue" is not mentioned in the AMA policy. It's always been a tenet of social media that open discussion among users will self-regulate user-generated content and that no "official" sanctions need to be applied except in the most extreme cases.

The issue of correcting mis-information on social networks also came up as one of the questions FDA asked about pharma's use of social media (see "Should Pharma Companies Correct Drug Misinformation Posted on 3rd-Party Social Media Sites?" and "Are There Special Cases for Correcting Misinformation on Social Media Sites?"). The consensus seems to be that the correction of misinformation by pharma should not be mandated by FDA regulators. Also, people who responded to my FDA survey generally felt that information aimed at healthcare professional audiences required even less need for corrective action because of the presumed ability of these audiences to appropriately assess and filter the information.

One commenter said this about information posted by physicians:

"Health care professionals should have the correct information as determined by consensus and should be reminded to not misrepresent the information. They have more influence if it is known that they are professionals so they can cause greater damage from misinformation. Some people calling themselves health professionals are misrepresenting their real qualifications. Again, as an example, the scienceblogs will review the qualifications of an individual calling themselves a 'health expert' while also commenting on the distortions of the information."