Will FDASIA Get FDA Off Its Butt to Finally Issue Social Media Guidance?

I noted with interest the headline in today's FDA News email: "OPDP: Social Media Guidance Will Be High Priority in 2013"." Here's the teaser copy that explains what's going one:

"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014."

I have three comments regarding this:

1. I reported back in July 2012 (here), about a little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act", which was signed into law by president Obama on July 10, 2012. This provision simply states: "Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."


2. This is NOT the FIRST time Abrams has promised that social media guidance was a "priority." At the November, 2009, FDA public hearings on social media, Abrams said he heard "loud and clear from folks in this room" (ie, pharma companies) that "we want guidance on social media... We heard that message. Let me tell you that we are devoting a lot of resources and effort to this" (read this: "Is It Time for Abrams to Leave?").


3. Although it's nice that Abrams says social media guidance will be "at the top" of FDA's work plan for 2013, I wonder why it was REMOVED from the published work calendar as far back as 2011 (read this: "FDA Drops Social Media from Its 2011 Guidance Agenda").

So, will Abrams keep his promise this time? Pardon me for being a doubting Thomas. You think a "do nothing" Congress that's facing a "fiscal cliff" will spend any energy to make sure the above "provision" is adhered to by the FDA? I said it before and I'll say it again now: If FDA misses the deadline set by FDASIA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.

A little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA, pdf), which was signed into law by president Obama on July 10, 2012, simply states:

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET.

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

Does that mean the FDA will deliver? If not, it wouldn't be the first time that a government agency missed deadlines imposed by Congress.

Usually, Congress specifies that regulatory agencies must issue regulations that spell out how to comply with the laws it passes. Regulations, therefore carry the weight of law. FDA Guidance (guidelines), however, is just FDA's current thinking on a topic. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."

So, if FDA misses the deadline set by PDUFA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

The only thing interesting about this provision of the PDUFA act is why it was included and who lobbied to have it included? It couldn't have been Pfizer (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"), but it could have been PhRMA (see "PhRMA Statement on FDA Social Media Guidance Delay").

Here Come the Pharma Wikipedians!

Should pharmaceutical companies appoint employees as Wikipedia "spokespeople" to perform all edits to Wikipedia articles on behalf of the company? That is the opinion of Bertalan Meskó, MD, founder and managing director of Webicina.com, who invited pharmaceutical companies to "employ a Wikipedia editor if you want to make sure only evidence-based information is included in entries about your own products" (find his letter here).

Recall that PhRMA -- in comments submitted to the FDA (see "Accountability for Pharma Content on Social Media Sites") -- suggested that manufacturers would welcome correcting misinformation about their products posted to sites like Wikipedia if these corrections were not subject to FDA regulation.

"FDA," said PhRMA, "should confirm formally that, while it is not possible for manufacturers to monitor or correct all inaccurate information about their products on the Internet, such corrections by manufacturers in response to inaccurate postings will not be considered promotional labeling. FDA's adoption of such a policy would thereby allow manufacturers to correct inaccurate information about their medicines on the Internet or social media (e.g., Wikipedia, Sidewiki, blogs, or other websites) if they should become aware of such information."

PODCAST
Pharma does not have a stellar record when it comes to editing Wikipedia articles. See, for example, "Simply Irresistible: Abbott Tampering with Wikipedia Entries" and "Web 2.0 Pharma Marketing Tricks for Dummies." So it's no surprise that this raises a number of interesting issues that were hotly debated during a recent #hcsmeu Twitter chat. That discussion will be continued in a Pharma Marketing Talk podcast on Tuesday, July 17, 2012. You are invited to listen or call in with your opinions. For more information, go here.

SURVEY
Meanwhile, I invite you to respond to the short survey below, which asks your opinion regarding the issues. Specifically, the survey asks whether or not you agree to the following statements:

• Pharma should NOT correct Wikipedia "misinformation" under any circumstances.
• Pharma should appoint employees or hire outside "Wikipedians" (ie, trained specialists) to edit "misinformation" on Wikipedia.
• When pharmaceutical company employees or agents correct "misinformation" on Wikipedia, they must reveal their ties to the company.
• When pharma corrects Wikipedia "misinformation" about Rx products, FDA should NOT consider this promotional labeling subject to regulation.
• If pharma edits Rx information on Wikipedia and this information is later re-edited by others, pharma should not be held responsible for any resulting misinformation.

Create your free online surveys with SurveyMonkey, the world's leading questionnaire tool.

"Low Hanging Fruit" Keeps FDA Busy & Out of Pharma's Social Media Hair

Another tidbit I picked up this week at CBI's 3rd Annual Forum on Social Media Regulations and Compliance is the notion that the FDA is too busy going after the "low-hanging fruit" of promotional violations to pay much attention to violations of regulations involving social media and other esoteric Internet "tricks" such as the manipulation of meta tag data.

This came up in a discussion I started about the use of meta tags to create organic search results that are effectively branded ads lacking the FDA-required important safety information (ISI). I discussed this in previous blog posts (Who's in Charge of Your "Invisible" Metadata? WARNING: Don't Invoke the "Invisibility Rule" and Are Organic Search Results Next on FDA's Chopping Block?):

Metadata is usually "invisible" content inserted within the header of the HTML code that creates a Web page. This includes a "description" of the page or Web site and keywords. Some of this information is used by search engines to find the page and include a description of the page in the natural search result.
When you do a Google search on "Viagra," for example, you will find a "sponsored" link (i.e., paid search ad) like this:



You will also find this unpaid natural search result:



BOTH the paid ad and the search result contain content that is written and controlled by Pfizer. The natural search result content that begins with "Learn about..." is exactly the content that Pfizer included in its "description" meta tag within the HTML code for the viagra.com home page. Google just lifted that content. Users cannot control this content, only Pfizer can -- by editing the meta tag.

A medical/legal/regulatory (MLR) expert in the audience said: "The fact that the FDA may not be pressing that issue right now is because of the low-hanging fruit." He went on to further speculate that even when FDA issues its long-awaited social media guidance this practice would not be addressed because the FDA is looking at "larger organic issues."

I contend, however, that the FDA has already addressed this issue in a notice of violation (NOV) letter to Novartis regarding the use of meta data to create a "Facebook Share" social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (see Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget). Organically speaking, this seems to be equivalent to using meta data to create a search result as described above, no?

Branded Tweets Lacking ISI: What's FDA's Thinking on This?

This week, I attended CBI's 3rd Annual Forum on Social Media Regulations and Compliance in Alexandria, VA. Many of the medical/legal/regulatory (MLR) presenters and attendees were from smaller pharma and biotech companies such as Biogen, MedImmune, Astellas, Amarin, Ferring, etc.

In the absence of specific social media guidance from the FDA, several presenters tried to "navigate through current guidance and enforcement" to offer advice on how to develop a compliant social media strategy. This technique is what is often referred to as learning from "received precedent," which is a risky methodology considering FDA's past actions that have contradicted previously-accepted precedents (see, for example, "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!" and "FDA's Actions Speak Louder than Its Words").

One topic that was discussed by at least a couple of presenters was who controls the content on social media and, specifically, what content is pharma responsible for when it engages in social media conversations.

Glenn Byrd, Senior Director, Regulatory Affairs, at MedImmune, spoke about pharma accountability in his presentation. "At what point do we lose control of our content? When do we lose the responsibility [for content] so FDA does not come after us?" He cited "retweeting" as an example. As an non-social media example, Byrd talked about B-roll video, which pharma companies often provide to TV news stations when they are doing a story about a newly released product. "They [the news outlet] take it and they do whatever they want with it," said Byrd.

Of course, the B-roll itself must be compliant with FDA regulations. If it mentions a drug name and its indication, for example, it must also provide the important safety information (ISI) just as if it were a direct-to-consumer (DTC) ad.

But pharma companies are using Twitter to tweet about brands and their indications WITHOUT including any ISI. Take for example this LYRICA tweet that @pfizer_news sent just this morning:

This links to the press release, which has all the necessary ISI. It's as if Pfizer still believes in the "one-click rule" when it comes to tweets linking to press releases. The logic is this: there is no "received precedent" of FDA citing such tweets as violative, therefore it is perfectly OK for us [Pfizer] to do this.

Note that the tweet has been "retweeted" at least 8 times and cited a "favorite" tweet at least 3 times. The tweet has also been posted to the Pharma Marketing "News From the Pharma Industry" Forum (see here) where anyone can post a "reply" message. Thus, an ongoing conversation out of Pfizer's control can result from this tweet on Twitter and on discussion boards. That is the viral nature of social media.

While Pfizer cannot be held responsible for the retweets of its branded tweet or the conversations it may start elsewhere on the Internet, it should be held responsible for the original tweet, which is similar to the search ads FDA cited as violative in 2009 (ie, lacking important safety information).

What do you think?

Shire Seeks to Maintain YouTube "Loophole" in FDA's Draft Guidelines for TV Ads

FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements." In past posts I reviewed comments from PhRMA (the drug industry U.S. trade association) and Sanofi (see here and here). In this post, I report on comments made by Shire (find Shire's comments here).

Shire, like Sanofi, Novo Nordisk and Boehringer Ingelheim (BI), believes that submission of a final recorded version of a TV ad for FDA approval prior to being aired would be "burdensome." Shire specifically cites the optional two-step process FDA suggested; i.e., first submit an annotated storyboard and then a final recorded version of the ad. "This sequential two-submission process would double the time and resource burden on sponsors as well as the Agency," says Shire.

Serial OPDP Review Blues
BI also mentioned the "burden" of a two-step process in its comments to the FDA (find them here). But BI was referring to the need to resubmit a new version of the ad after receiving critical comments from the FDA concerning the first version submitted for review. 

"BIPI is concerned with the incremental time and cost that would be incurred by sponsors to routinely produce and submit multiple broadcasts for the purpose of OPDP [FDA's Office of Prescription Drug Promotion] pre-dissemination review," says BI. "BIPI is similarly concerned that the repeated submissions of storyboards to capture serial sets of OPDP suggestions (i.e., the submission of modified storyboards for advisory comments following integration of initial advisory comments) would greatly increase the time, if not the cost, of producing DTC broadcast ads." 

BI says that it "behooves sponsors to ensure storyboards submitted for advisory comments are representative of the final ad and to ensure that the Agency's comments are incorporated into the filmed version." In other words, BI suggests FDA just look at storyboards and trust that the sponsor will create a final "filmed" ad that is revised according to FDA comments.

Shire, however, was the only pharma company to point out a "loophole" that I revealed on Pharma Marketing Blog in March (see "A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads"). In that post, I said:

"FDA does not define what exactly it means by 'dissemination.' Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for 'pre-dissemination' review. The video can then be embedded in the drug.com website or promoted via Twitter."

Shire pointed out the same lack of clarity in its comments. "...there has been increasing availability and use of vehicles other than broadcast TV to present video advertising, such as on-demand viewing via the Internet," says Shire. "Shire recommends that FDA affirm that the scope of the guidance includes only DTC advertisements disseminated through broadcast television."

FDA and the drug industry continue to see no need to issue any mandatory or even voluntary guidelines specifically for drug promotion via the Internet. Shire points out, for example, that there already is an "advisory review process" that applies to video advertisements disseminated through "other viewing platforms' (i.e., the Internet). That process (see here) says "a sponsor may voluntarily submit advertisements to FDA for comment prior to publication."

However, if "dissemination" is defined according to Shire's rules, then it is possible for a drug company to run a video ad on YouTube months before it airs the same ad on TV without having to submit anything to the FDA for review -- the current "advisory review process" that Shire refers to is voluntary.

As part of that process (e.g., submission of static storyboards for video ads), FDA estimates that "approximately 2 hours on average would be needed per submission, including the time it takes to prepare, assemble, and copy the necessary information." Compared to that, the creation of "final filmed" versions of TV ads is indeed a significant burden on sponsors. However, since FDA's new guidelines are specifically aimed at products with significant safety concerns, it "behooves" the drug industry to carry that "burden" in the interest of patient safety, IMHO.

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.

Did FDA Entrap Google with Those 14 NOV Letters?

Con Artist Reveals All About Google Drug Ad Sting - How FDA May Have Entrapped Google Using Those 14 "Infamous" Notice of Violation Letters

In an interesting article in today's Wall Street Journal, a convicted con artist details how he was employed by federal agents -- including agents of the FDA's Office of Criminal Investigation -- to lead a sting operation against Google's illegal drug ad operation (see story here). Recall that last summer Google agreed to pay $500 million to settle DOJ charges that it helped illegal online pharmacies target ads through its AdWords platform. It was one of the largest forfeitures ever paid in the U.S. (see "Google Settles with DOJ - Admits Aiding Illegal Online Drug Sales").

"It was very obvious to Google that my website was not a licensed pharmacy," said David Whitaker, the prisoner who acted in the sting. "There was a part of me that felt bad," Mr. Whitaker wrote in his account of the undercover operation viewed by The Wall Street Journal. "I had grown to like these people." But, he said, "I took ease in knowing they.. knew it was wrong."

What is of interest to me is the timeline revealed in the WSJ article. I added a couple of events to this timeline shown below (click on the image to enlarge it for better readability).

Mr. Whitaker made first contact with Google in March 2009. On April 2, 2009, FDA made public those "infamous" 14 notice of violation (NOV) letters that effectively shut down Rx drug search advertising on Google. In October 2009, comScore data was released that documented this "prompt, precipitous, and prolonged" drop in paid search advertising (see the chart here).

At the time of the announcement of the Google settlement, I suggested that because of FDA's involvement in the case, the agency delayed issuing guidance relating to the proper use of Google Adwords for branded Rx advertising. I suggested that the FDA did this to force Google to the bargaining table and to ultimately accept the draconian settlement terms mentioned above. In other words, FDA was holding Google's pharma Adword business "hostage" until a settlement was reached. See my argument here.

Looking at the above timeline, however, I now believe the 14 letters were sent so that Google might be more easily persuaded to run illegal drug ads to make up for the revenue lost from legitimate Rx drug ads. If true, this looks like a form of entrapment.

Keep in mind that the type of ads targeted in those 14 letters had been running for many years and that I, for one, maintained they were illegal starting way back in 2006 (see The "Girl from Google"). At the time, I submitted a written complaint to the FDA. Why did the FDA wait almost 3 years before getting around to stopping these ads? The answer, I believe, is what I surmised above -- it was simply a ploy to incentivize greedy Google ad executives to fall for the sting. According to the WSJ article, Google's ad executives "worked with Mr. Whitaker to find a way around Google rules."

P.S. Google may have tried an "end run" around the entrapment by coming up with a new ad format for Rx drugs that addressed the issue cited in the 14 FDA letters. This format was announced at the November, 2009, public hearings (see "Is Google the New FDA?"). The ad was actually "beta" tested by Bayer, but to date the FDA still has not formally approved the format and not many other drug companies have used it.

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!

Is the Pharma Industry Responsible for FDA's Delay in Issuing Social Media Guidelines?

I just read an interesting MM&M piece about how measures to curb the deficit might impact the pharmaceutical industry (see "Pharma Marketing Outlook 2012: Detailing D.C."). One small comment caught my attention: "A first draft of what is likely to be one of several not-crystal-clear guidances on social media and Internet communications has been circulating at FDA for most of the year, held up over legal worries." [my emphasis]

Oddly, no details were offered regarding the nature of the "legal worries." As the author of the MM&M piece probably knows, I wrote about this back in July when I suggested that a "Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance" (here). The petition asks for "comprehensive, clear and binding regulations" as opposed to "guidelines," which are non-binding (ie, can easily be changed by the FDA).

Before granting a petition, FDA staffers evaluate it, "a process that may take several weeks to more than a year, depending on the issue's complexity," according to the FDA.

Why is this such a big deal? I have pointed out that if the petitioners -- Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis -- are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" ( further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

In particular, the petitioners are looking for more guidance in four key areas: scientific exchange, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines, and responding to unsolicited requests for information. It seems that the FDA changed its social media agenda -- thus further delaying issuance of guidance -- to satisfy these specific needs (see "FDA Drops Social Media from Its 2011 Guidance Agenda").

You can find and read the petition here.

Another, related, "legal worry" that could be holding up FDA's issuance of social media guidance is a "friends of the court" brief to the court hearing the appeal of the Caronia off-label promotion case. This petition was filed by some of the same pharmaceutical companies mentioned above (see "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing"). The companies -- who call themselves the Medical Information Working Group (MIWG) -- contend that FDA's regulations "lack coherence and clarity." MIWG is talking about regulations regarding off-label information disseminated by regulated companies such as themselves.

This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."

Deconstructing Pitts' Guiding Principles for Pharma Social Media

Peter Pitts over at DrugWonks Blog has put together 11 "principles that must serve as the basic substrate of regulated social media participation" (see here). Pitts offered these principles because he is urging the pharma industry to participate in social media and not wait for FDA guidelines "not because of its potency as a marketing vehicle – but because it’s the right thing to do." Let's take a closer look at "Pitts' Principles."

Principle  1. "We engage in social media to help improve the lives of patients and advance the public health of our nation."

"improve" is the key word here. We all have different definitions of what it means to "improve  the lives of patients and advance the public health of our nation." I, for example, think it is very important to make sure all Americans have affordable healthcare insurance and support efforts to close the gap in Medicare Part D coverage (ie, the "doughnut hole"). The drug industry may not agree with me 100% on this. Lilly, for example, hosted a Twitter "chat" that tried to convince people that Medicase isn't broken, so don't fix it, but I asked "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?" (read this post). Also see "More Pharma Twitter Chats: Medicare is Topic."

Even if we agree on how to improve patient lives, it has not been proven that social media actually can help in this effort. There are plenty of other ways that the drug industry can -- and does -- do things to help improve patient lives. Perhaps social media can help in those efforts (see, for example, "Boehringer Ingelheim and Ashoka Make More Health via Social Media."

Principle 2. "We will thoughtfully engage in social media while remaining in compliance with both the letter and the spirit of FDA regulations."

The word "thoughtfully" requires definition, IMHO. There have been many occasions when pharma companies have seemed to put little thought into their social media activities (see, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). 

Seriously, however, "thoughtful" implies best intentions as in showing consideration for the needs and sensibilities of other people (eg, "how thoughtful of you!"). Perhaps Pfizer lacked "thoughfulness" when it promoted on FaceBook a Chapstick ad that angered quite a few women (see "Pfizer's Facebook Fiasco: Chapstick Slapstick Ad Uses Woman's Ass as a Prop").

Principle 3. "Our social media engagements will have both strong public health themes and appropriate marketing communications."

IMHO, "appropriate marketing communications" is the big elephant in the room that cannot be dealt with UNTIL the FDA says what is and what is not "appropriate." This requires more than being compliant with the "spirit of FDA regulations" as noted in Principle 2. It requires being compliant with the "letter" of FDA regulations. Of course, without the "letter" being written by the FDA, there can be no compliance with it.

Principle 4. "All social media messages and partnerships must be accurate, appropriate and transparent."

Pitts said "One principle that runs as a red thread throughout all of these 11 principles is transparency. Real, honest transparency – not the usual translucency that 'in compliance' often brings." I can't agree more. But this is where the drug industry will have problems. I can cite many instances of lack of "transparency" in pharma's social media activities that I have blogged about. For example, during a Lilly-hosted Twitter chat about Medicare, I suspect an employee or agent hired by Lilly posed as an ordinary citizen (@ellsbelles3) who posted "I keep hearing that Medicare Part D is working and not to change it. what does that mean?" This sounded suspiciously like a setup from a phony ordinary citizen similar to "Joe the Plumber" (see "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). Although I suspect that Lilly was not being transparent about this, I cannot prove it. That's the problem with transparency in social media -- nobody can prove you are not a "real patient" and it's very easy for unscrupulous players to manipulate the game (ie, conversation).

Principle 5. "We believe that social media presents multiple opportunities to learn more about how our products impact the lives of patients."

Sounds good to me. I hope that pharma is actually listening and learning. It would be interesting to know exactly what the industry is learning about its products from monitoring social media. However, very few companies will even admit they are monitoring social media for fear that FDA will learn that they are not reporting adverse events they hear about (see Principle 7).

Principle  6. "We believe that social media engagement allows us to correct errors and misperceptions about both our company and our products."

"correct errors and misperceptions" is really a slippery slope. Who defines what is "correct" and "not correct"? There are many scientific studies and clinical trials whose results are challenged by the drug industry but that are accepted as correct by other experts. All sides of a debate involving scientific evidence should be discussed with the (transparent) participation of the industry. But if the goal of the drug industry is to "correct" other points of view, then the industry will not be engaging in discussion but trying to manipulate it. Also, keep in mind that the industry itself has often been caught make false statements about its own products -- hence all the warning letters from FDA!

A little pedantic aside: "misperceptions" is a curious word choice. Since Pitts is known to choose his words carefully, the distinction deserves some analysis in the present context of "misperceptions" of drug products by the general public.

According to Grammarist: "To perceive is to become aware of something directly through the senses. To conceive is to form something in the mind or to develop an understanding. So to perceive is merely to see something, and to conceive is deeper. But perception often involves passive evaluation, and this is where the line between the verbs perceive and conceive becomes blurred. Think of perceptions as relatively shallow interpretations, and conceptions as more creative interpretations involving substantial thought or imagination. Think of a misperception as a mistaken impression... and a misconception is a mistake of imagination or interpretation." A simpler distinction: Misperception, means to not understand, misunderstand; Misconception means a mistaken thought.

It's possible that patients, for example, might believe that a muscle ache after being prescribed a statin for high cholesterol is a side effect of the drug. This could be a "misperception" (not a a true pain) or a "misconception" (a real pain but not caused by the drug). Another example: some patients may believe the risks of a drug outweigh the benefits and then decide not to adhere to the treatment regimen prescribed by their doctors. Is this a "misconception" or a "misperception?" Of course, it may be neither: the risks may actually outweigh the benefits!

Anyway, perhaps a better word to use in this context would be "misunderstandings."

Principle 7. "We believe in using social media to discover adverse drug experiences, which will then be addressed off-line."

I like this, but would like to see more real-world examples. I recall only one example of a pharma company that has publicly embraced discovering AEs via social medias: ie, UCB, which partnered with PatientsLikeMe  to create an online, open epilepsy community that includes a pharmacovigilance program to monitor the site for adverse events and report directly to the FDA adverse events associated with UCB products (see "Finally, a Drug Company Embraces Social Media, AEs Included!"). I haven't heard much about this lately -- did UCB find many adverse events and what else did they learn (ie, re Principle 5)? I've seen several studies by agencies that work for the pharmaceutical industry that suggest very few reportable AEs are found on social media sites. PatientsLikeMe, however, reported that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (see "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members"). Also see: "The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting."

Principle 8. "We will strive to interact in a timely manner, appropriate to the general expectations of social media."

I expect there's a difference in opinion of what is meant by "timely." As has been demonstrated many times, pharma can get into trouble when it does not respond in a timely fashion to social media crises as was the case with Sanofi's response to a disgruntled patient (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). The ultimate decision of whether a response is "timely" or not is up to the customer (ie, patient, physician, or payor). Whether "striving" is adequate or if "succeeding" is better, remains to be seen.

Principle  9. "We believe that social media must be regularly monitored and our programs measured in real time to gauge effectiveness."

See my comments under Principle 5. The industry also is struggling with how to "measure" social media campaigns. There is also a question whether or not social media should even be campaign-oriented, which implies a beginning and an end.  We've already seen pharma companies shut down Facebook pages and abandoning their social media audiences (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?"). Companies are blaming new Facebook rules for the shut-downs, but I think "campaignitis" has hit -- new marketers come on board and want to run their own "campaigns" or the "campaigns" were not as successful as expected. Which leads me to ask, How do you measure social media success?

Principle 10. "We respect but are not responsible for user-generated content that resides on sites we do not control."

This should not be a principle. It's just common sense. Duh! But wait! The word "control" needs to be defined. Comments to FDA by several drug companies addressed this.

Principle 11. "We believe the path to engagement is through useful and thoughtful content and commentary."

I've already commented on "thoughtful" (see Principle 2). "engagement" is a key word here. What do pharma marketers really think of when they think of "engagement?" Is it the same as what you or I think of? If pharna social media programs are controlled by marketers or corporate communications people, it's difficult for me to think the goal is not just "engage" but also to "convince." That was my criticism of the Lilly chat regarding Medicare (see "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). Also see "Will Patients Find Value in Discussions with Pharma Marketers on Social Media Sites?" 

A book can be written about this stuff and I suspect someone out there is already finished with the first draft. I thank Peter Pitts for drawing up these 11 principles around which we can organize an ongoing discussion. I invite your comments.

Your Wife, Your Choice - Diapers or Detrol (now Toviaz)?

Pfizer's @pfizer_news Twitter account just posted this tweet:

"Toviaz top-line primary endpoint results positive in overactive bladder study of nocturnal urinary urgency http://t.co/OU60l6oZ" (see here). 

The link is to a press release that reports the results of a study that purports to show that Toviaz (a reformulation of off-patent Detrol) is "statistically significantly superior to placebo" in treating OAB (Over Active Bladder). The "statistically significantly superior" results were "based on patient self-reporting," which is a very subjective measure of efficacy to say the least.

OAB is one of those "medical conditions" that has been refurbished by the drug industry so that more people -- especially women -- can believe they have a problem requiring treatment by a pill rather than by some other, less invasive, means. I wrote about this before -- see "Overactive Bladder: 'Pharmacia instrumental in creating new disease' says Former VP." Pharmacia was purchased by Pfizer after that post was made.

An anonymous commenter to that post said:

"In the case of OAB, Pharmacia (and later Pfizer and others) provided an acceptable name for the condition, increased awareness, and provided access to effective treatment for a large group of patients (women especially) suffering a hugely difficult condition. Your wife, your choice - diapers or Detrol?"

I thought the last sentence was worth immortalizing in the title of this post because it is said that OAB is one of those conditions that "women especially" suffer from.

The Pfizer press release claims that "approximately 33 million Americans are estimated to suffer from overactive bladder symptoms." It doesn't say how many of these Americans are women, but the Toviaz Web site features a woman posing as a patient ("Not an actual patient") as in this banner:

Yesterday, I asked "Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?" (see here). Toviaz ads (eg, the Toviaz.com Web site) demonstrate how women are targeted by direct-to-consumer (DTC) advertisers. As I mentioned in yesterday's post, I plan to discuss this in an upcoming Pharma Marketing Talk LIVE podcast discussion tomorrow (see "How to Score With Women (as a Marketer) via Social Media").

One other thing I have to say about the @pfizer_news tweet is that it is an example of a branded tweet that may not comply with FDA regulations because it mentions a brand name drug plus its indication but does not include any "fair balance" (ie, major side effect information) as required by law.

Most pharma social media initiatives such as company blogs and twitter accounts (including @pfizer_news) are managed by corporate communications people who are increasingly taking on the role of brand marketers. These people tend to think of themselves as outside of FDA's purview. Consequently, Pfizer may claim that the Toviaz-branded tweet is notice of a press release, not advertising, and that the press release contains the necessary fair balance (albeit one click away).

In the post about OAB mentioned above, I included slides from a Pharmacia VP that demonstrate the importance of PR and the media in "creating a new disease." One slide said "Drive potential patients to physician offices by using DTC and PR with symptom recognition." Another slide (see below) shows that the Media are an important component in creating consumer demand:

Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing

"FDA’s regulations censor manufacturers," says the Medical Information Working Group (MIWG), an "informal" group of pharmaceutical companies that includes Allergan, Amgen, Boehringer Ingelheim USA, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk, Pfizer, Purdue Pharma, and sanofi-aventis U.S.

In a "friends of the court" brief to the court hearing the appeal  of the Caronia off-label promotion case (see here), the MIWG contends that a manufacturer that "speaks about the lawful off-label uses of its products subjects itself to potential enforcement action unless FDA and DOJ determine, in their sole discretion, that they will not treat the speech as evidence of an 'intended use' for the product. This creates a chill on manufacturers’ speech, which has serious potential consequences for physicians, patients, and the public health."

Because of FDA's regulations that "lack coherence and clarity," MIWG claims physicians will have difficulty obtaining "objective, balanced, and accurate information on important unapproved uses of approved products." Furthermore, MIWG contends that pharma companies are "uniquely positioned to provide physicians with such information."

That's rich, considering that the drug industry often has difficulty providing "objective, balanced, and accurate information" on APPROVED uses of drugs as evident from all the FDA warning letters, which address this difficulty (for a list of the most recent letters, see here).

Should the heat the drug industry is bringing against FDA's off-label authority succeed, I envision off-label "woolly mammoths" (aka, sales reps) breaking free of the chilly ice and running amok among physicians offering "objective, balanced, and accurate information" - all without any oversight!

Much has been written about this legal issue, which you can find here, here, and here. Aside from the "objective, balanced, and accurate" claim, what caught my attention in the language of the brief was the overlap in the arguments presented with arguments pharma (eg, Pfizer) has made about how FDA should (or should not) regulate the promotion of Rx drugs via the Internet and social media.

On page 10 of the brief, for example, the argument is made that so-called "safe harbors" (eg, FDA guidelines for distribution of off-label reprints; see "FDA's Good Reprint Practices Guidance") are "not the product of formal rulemaking" and are "in most instances explicitly 'non-binding'." This was the argument Pfizer made against FDA issuing social media guidelines (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). As part of that argument, Pfizer said that "for FDA to regulate in this sensitive area [social media] through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result." (NOTE: Both documents are written by some of the same lawyers.)

Another parallel appears on page 11 of the brief, which delves into "unsolicited requests." The brief noted that FDA allows pharma company representatives (eg, paid physician speakers) to provide off-label information in response to an "unsolicited request" (eg, a question from the audience; perhaps from a physician "planted" in the audience for that specific purpose?).

Recall that the FDA's 2011 guidance "agenda" called for the agency to issue guidance regarding "unsolicited requests" from any source, including the Internet. That particular guidance, says FDA, was part of its promised social media guidance (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Before FDA can do THAT, it has to contend with the legal issues raised by MIWG in its brief.

This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."

In Memory of Steve Jobs Will Novartis Sales Reps Really Embrace iPads?

Pharmalot reported today that "In a memo this morning, David Epstein, who heads Novartis Pharmaceuticals, wrote that before the end of next year, more than 80 percent of the sales reps will give up their PCs and switch all detailing and related work to iPads.'' The memo, which can be found here, is reproduced below:

Posted on 9:52 AM, 06 October 2011
In memory of Steve Jobs - a role model 

"Today a great man has died - one who has forever changed the world. A great innovator, a corporate leader and a visionary who would not take no for an answer. A man who could perceive customer desire in a very clear way, marry it with technology and compel an organization to execute at the highest level to deliver customers a truly unique and compelling experience. A man I adopted as a role model as we began to galvanize our organization to launch Afinitor at a meeting of our Oncology leadership held in Mexico in 2008. 

"Ultimately, after a long fight, he succumbed to the ravages of PNet (pancreatic neuroendocrine tumor), a cancer for which Novartis now has two approved medicines: Sandostatin LAR and Afinitor. With Steve Job's death it is clear that we cannot rest as we work to discover, develop and commercialize still better medicines. It is medical intervention - great doctors, surgery, medicines and more - that allowed us to enjoy having Steve on this planet just a little bit longer so he could inspire a new generation and give us great inventions like portable digital music, the iPhone, the iPad and iCloud. 

"In his memory we commit today that more than 80 percent of Novartis Pharmaceutical field forces around the world will give up their PCs and be executing their call planning, detailing, emailing, and communicating with each other and physicians via iPads before the end of 2012. Please help me to make this a reality. As a result we will be able to make more impactful calls thus better able to ensure that every patient who should be on one of our medicines has access. Our marketers will be empowered to more quickly update digital detail aids and interactive apps with the latest information. Our marketers will better understand almost instantly what our field forces find helpful in their daily work and what is useless. Our field forces will be able to get more of their work done during the day while waiting for their next appointment rather than doing administrative work later in the day. And there are many other possibilities. Let’s use our positive memory of Steve to do some more good in the world. I know we can."

Not so long ago, I was hearing that pharma companies bought iPADs without having a clear strategy for how they were going to be used. It was believed that thousands of these iPads were housed in warehouses and not deployed.

It seems that Epstein is using the "in memory of Steve Jobs" memo as a tool to empty his warehouses of iPads and encourage reps to use them "to get more of their work done during the day" and "do some more good in the world."

But what are Novartis reps saying about the iPad? Here are some tidbits I found on the Novartis board over at Cafe Pharma:

• We are the laughingstock. 'Oh look, there goes the reps that are so incompetent in getting their message across, they are replaced by an iPad!' Hey doc, wanna play Angry Birds with me? 
• Next step in e-detailing is downloading "e-rep" app (doc gets to pick male/female e-rep to interact with,,need samples? click!, need a quick product review? click, heard the latest about managed care in your area? click! 
• Actually...with iPads why do we need high priced reps? The managers will be fine...you...I wouldn't be too sure. 
• I'm going to record all calls with the ipads camera & upload to youtube & publish live as soon as the next severence (sic) is paid out

At least pharma reps are not "selling sugar water to kids" as Steve Jobs once said of John Scully when he hired him to run Apple. Scully promptly ran it into the ground.

Does this memo violate FDA Regulations?

P.S. Epstein's memo was posted to a site called FreePDFhosting.com, which allows anyone to upload PDF files for free (duh!). I am not sure who posted Epstein's memo to this site, but I doubt it was Epstein, who probably intended it to remain an internal document. 

However, now that it is a PUBLIC document, easily accessible by any one, is it subject to FDA regulation regarding branded communications?

I notice that the memo refers to Novartis anti-cancer drugs by brand name and includes the FDA-approved indication: pancreatic neuroendocrine tumor. However, the memo does NOT include any fair balance (major side effect information). Technically, therefore, this memo -- as it appears on FreePDFhosting.com -- violates FDA law. Since FreePDFhosting.com has a rule against uploading PDFs that are "illegal or violates any laws," the memo should be removed from the site (hopefully before the FDA sees it).