Happy Anniversary! First Ever Pharmaguy Social Media Procrastinator Award Goes to...

Today is the third anniversary of the first day of the 2-day November 2009, FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here, here, and here).

Shortly after that hearing, some FDA staffers lead us to believe that FDA would come out with social media regulatory guidance for the pharma industry by the end of 2010 (see here). That never happened.

Instead, FDA kept procrastinating and throwing roadblocks in the way such as proposing further studies (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines").

Meanwhile, to add insult to injury, Tom Abrams, head of FDA's DDMAC (now OPDP), keeps showing up at industry meetings where industry leaders were expecting him to announce progress towards issuing draft guidance. At one such meeting in February, 2011, Abrams spent a scant 4 minutes discussing social media guidance (read this). At that meeting, he said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Well, guess what? It's almost two years later and YouTube, Facebook, and Twitter are still BIG, if not BIGGER and nothing has come along that's bigger. [BTW, Abrams also pooh-poohed Groupon, which now seems prophetic! And Google eliminated sidewiki, which was a big concern at the 2009 public hearing (read this).]

In recognition of the role Abrams has played in all this procrastination regarding social media guidance from FDA, I hereby present to Abrams the first ever Pharmaguy Social Media Procrastination Award^TM.

This award, as you may notice, is the antithesis to the famous Pharmaguy Social Media Pioneer Award, which was recently given to the sanofi US diabetes team (see here).

The iconic Hawaiian shirt in the "Procrastinator Award" is dark, symbolizing the negative implications of procrastination versus the bright yellow, positive Hawaiian shirt image used in the "Pioneer Award."

Abrams continues to show up at industry meetings promising that social media guidance is a high priority at FDA and it will be coming soon -- perhaps as "soon" as July, 2014 (see here). Yet, we've heard it all before. That's why I think it is fitting that Abrams receive the the "Procrastinator Award."

If Abrams lives up to his latest promise -- which is doubtful, IMHO -- it would have taken the FDA only 4 years and 8 months to issue draft social media guidance. In terms of Internet/social media timeframes -- in which 2 years can bring BIG changes -- this is procrastination on an epic scale. But in terms of FDA guidance timeframes, 4 years and 8 months is par for the course (see, for example, "A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon").

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").

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.

Sanofi Says Proposed FDA DTC Guidelines Would Effectively Kill TV Drug Ads

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, arguing that recent "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads" (find it here) violates the Free Speech Clause of the First Amendment because pharmaceutical marketing is a form of free speech (see "PhRMA Demands that FDA 'Cabin' Its Discretion to Regulate DTC Ads").

Sanofi, on the other hand, in a comment submitted to FDA (see here) argues that "the process presented in the draft guidance would potentially require the sponsor [ie, Sanofi and other pharma companies] to cease the use of TV ads as a vehicle to educate consumers due to significant production challenges as a result of the draft proposed process."

The "process" that Sanofi is talking about is the requirement to submit a "final recorded version [of the ad] in its entirety." Sanofi is concerned that if the ad needs to be changed -- reshot and re-edited -- as a result of FDA pre-review, it be too costly and "resource intensive" for the sponsor.

Not all ads, however, will require FDA review before airing (see "Focus on Drug Safety Communication & TV DTC Advertising" for details) and it is not clear how much it would actually cost to redo the production to comply with FDA comments. Sanofi should have included some specific estimates of these costs and "resources" to bolster its case.

Sanofi offered a compromise. Instead of submitting a "final recorded version" of the TV ad "in its entirety," Sanofi suggests that sponsors submit an "annotated storyboard or animatic [animated?] version of the advertisement."

FDA already reviews storyboards submitted prior to ads being run. In at least one case, however, a violative ad was aired months after FDA had a storyboard in its possession. Only after the ad had run its course did the FDA issue a notice of violation (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?").

Sanofi also submitted a comment regarding FDA's requirement for "verification that a spokesperson who is represented as a real patient [in a TV ad] is indeed an actual patient." Sanofi asked that FDA clarify what type of verification would be needed. Would a "signed testimonial from an actual patient" be enough?

Snaofi may be planning to use more real patients in its TV ads as have other pharma companies (eg, Pfizer use of real patients in Chantix TV ads). I've documented one instance where Sanofi has used a real patient in a video ad on YouTube (see "Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels") but do not recall any TV ads for Sanofi products that used real patients.

Regardless of what verification FDA requires for TV ads, the guidelines only apply to TV ads and NOT to ads that run on YouTube. Hence, although these new guidelines may "kill" TV drug ads, they may be a boon for YouTube ads such as the Sanofi YouTube video mentioned above.

PhRMA Demands that FDA "Cabin" Its Discretion to Regulate DTC Ads

In a 20-page comment submitted to the FDA on May 14, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA), advised the FDA to "proceed cautiously and in a manner that fully protects the free speech rights of advertisers and patients" with regard to the agency's recent Draft Guidance for Industry on Direct-to-Consumer (DTC) Television Advertisements."

Recall that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement" (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

In its comments, PhRMA uses the word "cabin" as a verb, as in "clearly defined standards that cabin the reviewing official's 'unbridled discretion'" and "objective standards to cabin FDA's discretion."

Why does PhRMA want to banish FDA to a "cabin" in the woods as far it's discretion to pre-review DTC ads is concerned?

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, which is cited several times in PhRMA's comments. For example, PhRMA reminded the FDA (as if that was necessary) that the Supreme Court "recently affirmed that '[s]peech in aid of pharmaceutical marketing .... is a form of expression protected by the Free Speech Clause of the First Amendment.' Thus," says PhRMA, "when the FDA restricts the speech of pharmaceutical manufacturers and other regulated entities, the restrictions are subject to scrutiny under the First Amendment."

But the Supreme Court Court is not likely to scrutinize "informal guidance," which is not legally binding. Therefore, PhRMA is pushing the FDA to issue regulations, which carry the weight of law. "Regulations that unduly burden truthful, non-misleading commercial speech about a lawful product," says PhRMA, "hinder consumer choice ... and rarely survive constitutional scrutiny."

Of course, FDA wants to prevent "misleading" drug ads from being aired. Right now, however, it can only cite ads as "misleading" AFTER they have already been aired.

I'm not going to delve into the legal arguments that PhRMA puts forth. You can read them yourself here. I just find it interesting that the drug industry is pushing FDA to stop issuing non-binding guidances in this case as well as in the case of social media (see "WLF & Pfizer Ask Court to Block FDA Guidance on Social Media"). I also like how PhRMA uses "cabin" as a verb, hence the cabin image that accompanies this post.

Hat Tip to @AlecGaffney for alerting me to the publication of PhRMA's comments in the Federal Register, where "occasionally interesting reading [is] to be had."

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

Before I get to the "loophole," here's a summary of the guidance.

Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.

Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:

• Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
• Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
• Category 3: All TV ads for Schedule II controlled substances 
• Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
• Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision

"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA

Regarding the 45-Day Review Period, FDA says:

"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."

That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.

What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.

"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review."

After writing this, I had short Twitter conversation with Alexander Gaffney (@AlecGaffney), health wonk and writer of news for @RAPSorg & Regulatory Focus. Regarding FDA's requirement to review videos and not just storyboards, Alec said the guidance would likely cuts down on "poor marketing" spending, which I interpreted to mean "pushing the envelope" spending. In the past, pharma marketers could submit a storyboard (cheap) and run the ad without waiting for comments from the FDA. The ad could push the regulatory envelope and run its course on TV before the FDA could issue a warning letter. I commented on this previously. Read "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"

The "Loophole"
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.

The bright line between TV and online video is getting more blurry every day. I currently am able to watch Youtube videos on my TV via Apple TV. Of course, it is not the same as regular TV ads that I can skip over thanks to my new cable box that allows me to record programs and play them back later. And I may be the only person that would actively search out drug TV ads published on YouTube!

Would a pharma company want to do this? Maybe, if it does not violate the "letter" of the law; ie, is not classified as "dissemination." That would let the company off the hook for violating the law, but FDA could still cite the YouTube version as violative (ie, as it does right now). A violative YouTube version of the video could result in an FDA warning letter, which probably would be issued months after the ad was first uploaded.

Just my thoughts and a comment that I think the FDA should consider when developing its FINAL guidance.

FDA Mobile Regulatory Fear Mongering by PhRMA

In a blog post provocatively titled "An App for That, But For How Much Longer?" (here), PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. You can read the op-ed in this threaded archive: "How safe is that app? Should pharma apps be registered as medical devices?".

The op-ed author, Joel White, executive director of the Health IT Now Coalition, "suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' In the end, this could hinder the way that patients can actively improve their own care," said Conners.

Before I get to destroying the case made by Connors and White, I should point out how these two people are related. White is the president of JC White Consulting, a registered lobbying firm (see here) retained by the Health IT Now Coalition and PhRMA, among others (see here). In her blog post, Connors said "A few days ago, I missed an op-ed in the Washington Times that I just came across today – and I’m glad I did." Joel, you should have DM'd Kate! Whatever! It's nice that White gets paid to write this "independent" op-ed piece that PhRMA can cite as if it were independent! Guys! Wake up! It's the era of transparency! Unfortunately, you can fool some -- maybe even most -- of the people all of the time and that is what keeps PhRMA in business.

Anyway, back to "FDA Mobile Regulatory Fear Mongering." I say "fear mongering" because it can't be true that White and Connors failed to read FDA's July guidance in which it stated that the agency does NOT consider the following types of apps 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. 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."

PhRMA/White do not quote FDA because to do so -- as I just did -- would kill the argument that FDA mobile guideline/regulations will stymie pharma from developing apps and will "hinder the way that patients can actively improve their own care." You should also read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

Meanwhile, there are medical apps being created by pharma that SHOULD be regulated by the FDA, IMHO. These are "calculator" apps designed to be used by physicians during diagnoses. One such app had to be "recalled" because of a bug that generated incorrect results. Unfortunately, thousands of physicians may not have heard of the "recall," which merely removed the app from app stores, not from the phones of physicians who downloaded the app. These physicians may still be using the buggy app. See "The Problem with Unregulated 'Calculator' Apps for Physicians: Buggy Software!"

P.S. Connors pointed out that PhRMA has its own medication reminder app for patients: "In fact, we at PhRMA have helped support the Script Your Future campaign, which itself includes medication reminders as a tool."

Just for fun, I signed up to receive reminders. I was, however, somewhat put off by the long legal disclaimer, which said, in part:

"You acknowledge and agree that we provide the reminder service and access to the reminder service as an "as is" and an "as available" basis, that your use of the reminder service is at your own risk, and that we make no representations, warranties or covenants whatsoever with respect thereto. For greater certainty, we do not guarantee that the reminder service will be available, run error-free or uninterrupted, that we will correct all errors or deficiencies related thereto or that all messages sent by you will arrive at their intended destination on time."

ROTFL! In essence, PhRMA says it makes no promises that this app will be useful. How is this supposed to help me improve my care if PhRMA does not even care to fix errors or deficiencies? Not a very consumer-friendly attitude, I must say! BTW, I am sure the FDA did NOT require PhRMA to write that.

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.

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'."

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

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

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

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

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

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

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

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

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

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

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

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



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

FDA's Proposed Web Study Will Further Delay Social Media Guidelines

FDA has published in the Federal Register (click here) a series of proposed studies designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites.

This is BAD news for all us who have been waiting since November 2009 for the FDA to issues specific guidelines for use of the Internet and social media in promoting Rx drugs.

In its proposal (find my highlighted, annotated pdf version here), the FDA states:

"This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development [my emphasis]."

While it's interesting that the FDA now admits original regulations are not adequate in the "shifting dynamic" of today's Internet communication channels, FDA is essentially TABLING Internet guidance by proposing these studies. It's a classic bureaucratic delaying maneuver!

The first leg of the delay will be the 60 days beginning today necessary for the FDA to collect comments to its proposal via the Federal Register page linked to above. Then, FDA will have to review all comments regarding this proposal. Then, if FDA is not seriously challenged on the need for such studies (IS THERE REALLY A NEED?), it will implement the studies. After that it may or may not publish the results of the studies and Tom Abrams will go around the industry conference circuit presenting the results of the study while promising "to have these guidances out as soon as possible."

To which I say BULLSH*T!

Enough studies and hearings already!

I urge all who are interested to submit comments to the docket (here) and tell the FDA that these studies are NOT needed and that it should get off its ass and provide the industry with useful guidance.

P.S. Also, tell FDA it's time for Abrams to retire! (see "Is It Time for Abrams to Leave?").

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.

You can access the PMCPA "informal guidance" here.

While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!

Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the British industry code, US PhRMA's DTC Guidelines specifically excludes online communications.

Regarding Twitter, PMCPA has this to say:

"If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.

"Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

Back in October, 2009, I criticized tweets like this, which I thought violated FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). So far, however, FDA has not issued any NOV letters to companies who post such tweets. Maybe BI is out of the FDA's jurisdiction because the tweet was meant for an EU audience and not a US audience? And since BI is not a British Pharmaceutical industry, it is not obligated to comply with the ABPI Code.

While many industry pundits fault the FDA for not issuing social media guidance in a timely fashion, no one has put any blame on PhRMA (the US industry equivalent of ABPI) for not issuing its own voluntary industry guidelines regarding Internet and social media pharmaceutical promotion. No one but me, of course (see, for example, "PhRMA Finalizes DTC Principles").

FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It.

"The Food & Drug Administration is planning to release guidance for mobile medical applications in 2011, according to Center for Devices and Radiological Health director Dr. Jeffrey Shuren." That was reported in this story relaying comments made at a "town hall meeting" held March 10 in Irving, Texas.

I don't know nearly as much about Dr. Jeffrey Shuren as I do about Tom Abrams, his counterpart in FDA's DDMAC. But if he's making more promises that the FDA hasn't the ability to keep, then I urge that he resign along with Tom Abrams (see "Is It Time for Abrams to Leave?").

As you probably know, DDMAC first "promised" that it would issue social media guidance for pharmaceutical promotion by the end of 2010. When they missed that date, Abrams "promised" it would be done by the end of Q1 20011, which leaves only about 2 weeks for the FDA to fulfill that "promise."

Most observers, however, believe FDA will not deliver social media guidance before April Fool's Day 2011. Considering the looming budget cuts suggested by some anti-government bloat lawmakers, it could be a cold day in hell before FDA can spare the resources to get the job done as "promised."

Regarding mobile devices FDA has a much, much greater challenge in issuing guidance. The issue has to do with agency approval of Mobile medical applications as medical devices. So far, FDA has approved two mobile applications:

1. MobiUS, a smartphone-based ultrasound imaging application for use in obstetric, gastrointestinal, cardiac andother clinical applications.
2. Mobile MIM, a mobile diagnostic radiology application that facilitates viewing of medical images for diagnostic purposes via Apple’s iPhone and iPad devices.

FDA approval of these devices/applications hinged on image quality (see FDA Press Release). Of much greater concern, however, are applications that involve more complicated software. Whether or not the FDA would regulate mobile software has been an issue for nearly two years.

Is the FDA technologically competent enough to evaluate mobile App software? It's a valid question considering that many people have doubted that FDA was competent enough to understand social media and issue guidance in that realm. Software, which operates behind the scenes, is even more of a challenge.

Faulty software can make medical devices dangerous. Think of "HAL" in charge of millions of pacemakers. That sort of thing.

There is a relation between mobile medical Apps and pharmaceutical marketing. Many pharmaceutical marketers are developing mobile Apps. The latest one I've come across is Janssen's "Psoriasis" app for the iPhone and iPad (see it here on iTunes).

The physician version -- which any non-physician can easily access -- includes a "PASI calculator." PASI stands for "Psoriasis Area and Severity Index," which is a tool for the measurement of severity of psoriasis. According to the wikipedia entry, the following formula is used to calculate PASI:

I won't get into the details here, but I wonder if this is the equation used in the software that calculates PASI in Janssen's Psoriasis App? Does the software implement the equation correctly? Has it been tested and certified as correct? By whom?

Jannsen does include this statement in its disclaimer: "The information provided on this App is not a substitute for professional medical care." This is par for the course when dealing with consumers who may be using the PASI calculator without medical supervision.

But I can't find any information about the clinical validity of the PASI calculator, which is an issue I've often blogged about (see, for example, "Pharma Symptom Quiz Goes to the Dogs!" and links therein).

This is just a simple example of a medical App that depends on the accuracy of its software to function properly. If marketers design the Apps and hire outside tech agencies to develop the Apps, then there is the possibility that the software can be "gamed" to provide desired results (eg, higher PASI score) much like the software of Vegas slot machines are "gamed" to favor the house.

Is the Janssen Psoriasis App a medical device that needs to be approved by the FDA? I think that's a valid question to ask since the App encourages physicians to use it: "This interactive PASI calculator enables you to generate a PASI score for your patients."

P.S. Janssen says that the Psoriasis iPhone App is "Intended for a European audience." But it -- like ALL iPhone Apps -- is available on iTunes, which is a US retail Web site. Does that trump "intention" and does intention matter as far as the FDA is concerned?

P.S. See "Checking Under the Hood of Pharma Mobile Apps" for an update.

I'm Interviewed About Pharma & Social Media on This Marketplace Show Sponsored by Novo Nordisk!

About 2.30 minutes into this 8-minute Marketplace Morning Report is a short piece about pharma's use of social media for promoting drugs. I am quoted in the piece. Essentially, it's the same quote/sound bite that TIME used about pharma being "marginalized" if they do not figure out how to participate in social media discussions (see "Pharma is "Cleverly Navigating" the Social Media Space Says TIME Magazine").

My segment is preceded by an ad for Novo Nordisk, "since 1923 innovative developer of diabetes treatments and delivery devices." It's interesting that Novo Nordisk is a sponsor of this MarketPlace segment because its Race with Insulin campaign was also featured in the TIME magazine story, which called its twitter social media campaign "provocative."

Both stories are ambivalent regarding pharma's use of social media and may even be said to be supportive of pharma's cause to push the FDA into releasing guidelines. Both stories also say that FDA will release these guidelines before the end of the year.

It could be a coincidence that Novo Nordisk is linked to both these stories, but I'm beginning to feel that I am been played like fiddle by a Novo Nordisk engineered PR campaign! What do you think. Listen to the embedded Marketplace segment below (or find it here after it is archived as a podcast dated 12/20/2010).