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Social media enables celebrities to have intimate and frequent contact with fans. In particular, Instagram has served to give us a glimpse inside the daily lives of our favorite stars. Social media has also given birth to an entirely new breed of celebrities, YouTube “content creators,” who have a huge impact among tweens and teens.

When a celebrity endorses a product via TV commercial or infomercial it’s obvious that it’s an advertisement. Now the lines are blurred. In order to protect the general public and ensure that online influencers are transparent about payment and gifts, in 2009 the Federal Trade Commission issued Endorsement Guides. The FTC clearly explains the rules and makes it easy to accomplish by simply using #ad, #paid, #sponsored or #promoted in a post.

Beyonce 7

Beyonce is Crazy in Love with Airbnb

After the Super Bowl, Beyonce shared on Facebook a photo with the caption, “It was a Super weekend Airbnb” with a link to the Airbnb Facebook page. Neither the superstar nor the company will confirm if she was paid for the endorsement or comped the accommodation. If this was the case, then Beyonce would need to disclose that on the post.

Another example is Reese Witherspoon who has started a company, Draper James, and on Instagram frequently shares images of herself wearing the clothing. None of these indicate that she has a financial involvement in the company.

Best FDA Letter Ever

In August 2015, Kim Kardashian and Duchesnay admitted that she was paid for her endorsement of morning sickness medication, Diclegis, via Instagram. The post initially received attention for resulting in a letter from the Food and Drug Administration regarding her lack of fair balance in the post. Kardashian also did not note that there was a paid relationship.

Will the FTC Respond?

These are only the most popular examples, but a few months ago Jezebel identified many more personalities who are ignoring the FTC guidelines. Beyonce, Kardashian and Witherspoon are extremely sophisticated marketers with carefully curated social feeds, so it surprises me that they haven’t been made aware of the potential issues with the FTC. Perhaps it will take the FTC going after a high profile personality to make others compliant.

Image from Forbes.com
Image from Forbes.com

Kim Kardashian taught us all a tremendous amount about the perils of using social media for prescription drug promotion this week, but the real message seems to have been missed by most folks.

The media, who can’t resist an opportunity to write gimlet-eyed hot takes about the reigning queen of famous-for-being-famous, widely reported this week’s news that the U.S. Food and Drug Administration sent a warning letter to Duchesnay, the maker of the morning sickness drug Diclegis, after Kim Kardashian took to Instagram to extol its virtues.

The FDA warning was utterly unsurprising. While Duchesnay and Kardashian took some pains to include a link to safety information, the overall content is clearly a violation of the agency’s longstanding policies and recent guidance. (A link to safety information, once called the “one-click rule” and heralded as the best way to ensure that online promotion offers a fair balance between risks and benefits, has been utterly rejected by the FDA.)

These are not new issues to us. In fact, our expert teams handle social for pharmaceutical and healthcare companies daily. This was a rookie mistake by Duchesnay — or a blatant risky one. With priopriety analytics – including our exclusive MDigitalLife database of social activity by physicians – we drive global pharmaceutical and healthcare-related communications decisions across W2O, including WCG, Twist and BrewLife.

So while the FDA’s rules may be overly strict, they’re no longer that confusing. The Kardashian post, then, reflected some combination of ignorance, recklessness or calculated cunning that the risk of an FDA warning would be worth the flood of attention.

Except that there was never a flood of attention, at least, not the important kind.

It’s impossible to know if sales spiked, but we can look at whether Kim’s post prompted certain behaviors. The easiest behavior to look at is Wikipedia, where site visit stats are public, and where it’s been shown that searches are correlated to drug sales. There, the page for “pyridoxine/doxylamine” (the chemical name for Diclegis) was visited 99 times on the day that she posted her endorsement, rising as high as 148 later that week, as the media scrambled to report on it. (“Morning sickness” barely budged from its historical average.)

Google Trends shows much the same phenomenon: a small spike, but one that looks far less impressive when other pharmaceuticals are included as comparators.

So the net effect was that a post that went nearly 50 million people, many squarely in the young-mother demographic, and received upwards of a half-million likes, drove only a few hundred people to research more about the drug on Wikipedia. As a point of comparison, Angelina Jolie’s mastectomy pushed Wikipedia searches for “mastectomy” from 1,000 to 300,000 in a day: a 23,000 percent increase.

To be sure, it’s possible that enough people skipped Google and followed Kardashian’s web links and the impact was far greater, but the fact that so many eyeballs sent so few people to Dr. Google should raise red flags.

The lesson here is not that FDA rules should be followed (they should, and we can help) but that social media impact can’t be measured on likes alone (we can help with that, too). The Kardashian post was designed to catch the eye of people that mattered when it comes to pregnancy. It turns out that the heads that really turned were at the FDA.

These are exciting times to be involved with the medical device and diagnostic industry. It had hit a bit of a rough patch with a bloated “me-too” market, some bad press and an investment void for early technology… but things are looking up, according to buzz on the Street.

There’s a shift occurring, and this entrepreneurial, burgeoning-teenager of a market is maturing before our very eyes. Proof points include consolidation at the top with major M&As happening as manufacturers strategically align and restructure within the confines of our new healthcare landscape and regulatory environments.

As start-ups and emerging companies continue to fuel the industry with smart and intuitive innovation, the FDA’s recent rollout of its Expedited Access Pathway (EAP) is an encouraging development that will help get life-saving innovation to patients in need, faster. And in an industry where a novel idea can still catch the eye and pocketbook of an investor, IPOs are at a healthy volume and bankers anticipate another banner year for venture-backed device and diagnostic companies, with maybe fewer but more robust investments.

I recently listened in on an industry webinar from Medtech Strategist. This, as well as other recent medical device industry reports have left me on the edge of my seat for what’s to come. But possibly even more exciting is the realization that W2O Group is in the trenches and involved from the ground up with many of the industry’s most history-making medtech.

I’ve been geeking out on medical technology since my entrée into the field with hips and knees, back when metal on metal sounded like a good idea… I’ve always been drawn to a cool, new medical device that disrupts the status quo and challenges you to think about health in a new way. And as with all big ideas that challenge the standard, sometimes you win (big) and sometimes you lose (big), but the learnings are invaluable for the field, as we’ve seen recently with renal denervation and previously in spine and orthopedics.

I’m surrounded by fellow medtech junkies here at W2O Group. And from a communications perspective, we are partly and sometimes wholly responsible for getting the word out to physicians, patients and investors about life changing, inspiring new interventional therapy options – which keeps me coming back for more everyday.

We work with some of the most promising new innovations in the market, like drug-coated stents and balloons to open clogged arteries, intuitive pacing devices for heart rhythm disorders, TAVR for valve disease and seemingly-futuristic technologies like miniature cardiac devices and ingestible sensors that truly amaze.

There is so much more on the horizon for this field in areas like diabetes, neurology, robotics, and digital health and I’m planning to have a front row seat.

Front row seat

In the five years since the open public meeting on social media, the FDA has occasionally shared their thinking via letters and draft guidance. They provided more clarity on June 17, 2014 by simultaneously issuing draft guidance on two separate topics: “Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”

It’s important to note that both refer specifically to prescription drugs (human and animal) and medical devices. Let’s start with the first document, which I’m nicknaming “The Twitter/Paid Search Guidance.”

TWITTER/PAID SEARCH GUIDANCE SUMMARY

The draft guidance recommends how to include risk/benefit information on sp ecific channels with character limits (e.g. Twitter and paid search).

No matter what the space limitations, companies must post both the benefits and main risks associated with a product within the same message or tweet, with a hyperlink taking the reader directly to a more detailed list of risks (and not simply the homepage of the promotional site). They provide specific examples that include the use of URL shorteners, as well as common and scientific abbreviations. For paid search media advertising (e.g. Google and Yahoo!), this guidance outlines how companies can make use of multiple links within each ad to satisfy fair balance requirements.

Takeaways

  • Clear direction on how branded promotional tweets and paid search advertisements are possible.
  • Stresses that for products with complex indications or serious risks, it may not be appropriate to use digital platforms that have character limitations as a communications vehicle.
  • Other social media platforms with longer form textual opportunities are not in scope of this guidance; until further clarification, standard FDA promotional guidelines would still apply.

This FDA draft guidance offers new possibilities for brands.

Key actions

1)      Evaluate paid search advertising campaigns: Review any current brand promotional ads utilizing vanity URLs that redirect to the brand site. Consider creating new branded, promotional ads based on this guidance. We recommend performing tests to compare which type of paid search brand ads are more effective.  This draft guidance provides new options for promotional Paid Search ads that may prove valuable for brands—although it will need thorough testing to determine success.

2)      Consider if Twitter is right for the brand: In some cases, branded promotional Twitter accounts may support the brand goals. However, after the benefit/risk information and link to risk is included in a tweet there will be very few remaining characters left for additional messages or links. These instructions will likely make it very difficult for a brand to implement in practice. Reminder ads can still be used. In addition, the severity and complexity of the product or device (and the length of the brand/established names) may preclude the channel. Moving forward, it will be interesting to see how many brands are willing and able to utilize Twitter as a promotional vehicle.

CORRECTING MISINFORMATION GUIDANCE SUMMARY

The draft guidance recommends how companies may choose to correct misinformation (both positive and negative) related to their own product.

The FDA focus on “misinformation” defined as: Positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular.

Firms may choose to correct misinformation. This still holds true if the misinformation occurs in the context of User Generated Content (UGC), regardless of whether the firm owns or operates the platform (or not) on which the communication appears.

The corrective information does not need the full balancing of risks and benefits that are normally required, as long as the following criteria are met: be relevant/responsive, limited and tailored to misinformation, non-promotional in nature/tone, accurate, consistent with FDA label, be supported by data, post in the same area as the misinformation and provide full disclosure that the poster is affiliated with the company. A subtle (but important) recommendation is that a firm may choose to provide contact information, giving the example of the company’s Medical Affairs Department.  A strong suggestion that the corrective information has FDA-required labeling included or provided in a readily accessible format (e.g. PDF).

Companies do not have to correct each piece of misinformation in an entire forum, but should clearly identify what misinformation is being corrected, with as much specificity as possible. However, do not cherry pick and leave other more “positive” misinformation.

Also, in the unlikely case that a reportable Adverse Event is seen, follow the normal process.

Outside of scope:

  • Once the company corrects misinformation, company is not expected to continue to monitor.
  • If a company asks an author to correct misinformation, the company is not responsible if this does not occur.
  • A company does not need to submit corrective info to FDA, but should keep detailed records of all corrections and interactions.

Takeaways: 

  • Companies can correct fully independent third-party online misinformation without specifically exerting the full scope of fair balance.
  • Given limited resources of companies and the disparate levels of impact of different online platforms, it will be important to prioritize the platforms/forums before addressing misinformation (e.g. prioritize according to reach and relevance)

Key actions

1)      Analyze the popular online third-party information on your brand: If you don’t know already, determine where there is misinformation and how egregious it is. Then rate the sites for reach and relevance to your target audiences. This will help you analyze whether it is worth correcting misinformation and, if so, prioritize the sites. For example, if Wikipedia has misinformation on your product page, this would be worth the effort to correct as Wikipedia is an extremely popular destination for both HCPs and patients. We can provide the analytics data and work with clients to ethically and appropriately share information with Wikipedia.

2)      Ensure clear internal guidelines around how to correct misinformation:  Review current employee guidelines to ensure that they specifically address the issue. Make sure these include very clear instructions for employees about what to do if they come across misinformation (e.g. forward to Communications team); ensure there is clarity about who is allowed to make changes (e.g. Medical Affairs team) and how they must do it (e.g. full disclosure and requires approval). Roll out revised guidelines (and relevant training) in targeted manner to make sure all affected stakeholders (including partners/agencies) are aware and aligned.

3)      Education and training: In light of the guidance and the ever evolving landscape of digital communications, it will be critical to educate employees (and external partners, agencies, etc.) and ensure that they understand these documents and know explicitly how to proceed should they find misinformation.

Next Steps

Talk to your medical, legal and regulatory teams: Have a discussion around these new guidelines to learn their point of view. This is the POV that counts the most. We are available to help clients with this discussion.

Listening and analytics: It remains extremely important to have a finger on the pulse of the ongoing conversation around healthcare and social media. Monitoring brands online and the dialogue around them will help shed light on what is currently being discussed and how people are engaging—or hope to engage—with brands.

We understand that many questions still remain as the FDA will continue to evolve their recommendations, and we look forward to working with our clients to explore these new opportunities.

While my name is on this blog post as author, the thinking behind it came from a team of people including Colin Foster, Erin Bittner and Carissa O’Brien. One final note: I do commend the FDA for releasing this 3 weeks before the July 9 deadline – I was expecting it on July 3rd!

Our W2O Group hosted a webinar today (full link at bottom of this post) featuring a panel of our regulatory, corporate communications and social media experts to discuss an overview and potential implications of the FDA’s long-awaited draft social media guidance. Hopefully, this is the first step toward having more comprehensive guidelines to help pharma navigate the rules of the road for social media. To date, given the lack of definitive guidance, we have had to rely primarily on warning letters and employ common sense to help us cautiously steer the course and build engagement.

The FDA has described this guidance as pertaining to “Interactive Promotional Media” that aim to help healthcare companies determine if electronic communications using social technologies are subject to FDA’s post-marketing submission requirements. This is most impactful for branded, promotional communications.

Key Takeaways:
1. Be accountable for YOUR content
: This means not only content that your company produces, but also covers content generated by employees, agencies, KOLs, brand ambassadors, contracted sales reps, etc.


FDA_Guidance_Cover2.
The guidance gives brands more clarity on what is and isn’t within FDA’s promotional jurisdiction: For example, if a company provides only financial support, but doesn’t control or influence content, the company is not responsible for what goes there. However, companies still must share anything that they submit to a third-party if it’s posted on digital platform.

3. User generated content (UGC) is primarily the user’s responsibility: The guidelines also take pains to clarify a company’s responsibility toward content from independent third parties — even if it happens on a brand’s own Facebook page, blog or forum. A company generally is not responsible for UGC content, and FDA won’t ordinarily view UGC on company-owned or company-controlled venues such as blogs, message boards and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the company and the company had no influence on the UGC. 

4. Brands can (cautiously) practice real-time social media: When brands engage online, they don’t have to submit content for FDA review before it is disseminated through their channels. This further opens up the opportunity for brands to do real-time engagement (e.g. respond to Facebook posts, comment on a blog). The FDA makes it clear, however, that companies must collate all content they have developed and submit for review on a monthly basis.

5. So, what does this mean for your company’s social media properties? Our guidance is that, for now, we should continue running social media properties with a “business as usual” attitude, which is rigorous and vigilant in terms of review process, particularly with ambassadors, KOLs or other partners.

More definitive guidelines from the FDA are expected in July, but FDA has historically had shifting timelines, particularly around social media guidance.

One question that’s still outstanding is what will be necessary from a safety standpoint/fair balance in branded social media posts, especially when using a platform like Twitter that limits you from including that safety information. According to John Mack of Pharma Marketing Blog, this guidance is expected later this year. 

Webinar_screenFDA Social Media Draft Guidelines Webinar: Friday, January 24, 2014
https://w2ogroup.webex.com/w2ogroup/lsr.phpAT=pb&SP=MC&rID=40406592&rKey=8997212f3ded6151

The FDA has released draft guidelines for regulated healthcare companies on what they call Interactive Promotional Media. While not a comprehensive document about managing all social media content and channels, it is an important start on the road to clarity and the most direct guidance that the FDA has issued on the topic so far. And, according to John Mack, it looks like there is .

The outline the FDA’s definition of “interactive promotional media” and aim to help companies determine if their product communications using interactive technologies would be subject to the FDA’s post marketing submissions requirements. The womens ralph laure pony polo guidelines also make recommendations on how companies can submit materials for FDA review in a practical manner in the face of real-time information flow on social media platforms.

The latest draft guidelines provide some important insights about how the FDA looks at product promotion in the context of social media:

1. Be accountable for YOUR content (not external consumers): Good news for marketing teams and company regulators. There has been a fair amount of uncertainty on this point in the industry, which has probably been a key deterrent for brands to leverage social media channels in their marketing mix. While the FDA has provided more clarity on this, the definition of accountability is still quite broad, “A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.” In other words, this not only covers content generated by employees, but also content coming from people acting on behalf of the company (i.e. agencies, KOLs, contracted sales reps, etc). Despite this broad definition, this is the first time that the FDA has formally documented that they do not hold companies responsible for content they do not control.

2. The terms of engagement are “clearer”: With a few notable exceptions, brands have been watching online communities from the sidelines, not willing to engage for fear of crossing an invisible line with the FDA. The line has now been drawn, at least as it relates to promotional content shared by the advertiser, giving brands more clarity on what should be considered in and out of promotional jurisdiction, “…if a firm provides only financial support (e.g., though an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for the information on a third-party site and has no obligation to submit to the FDA.” In other words, if you share promotional content with 3rd parties (e.g. Influential bloggers) and they post something on their site as a result, your obligation is only to submit what you shared, not what they published.

3. Even your “brand-controlled” sites can allow engagement: The guidelines also take pains to clarify a company’s responsibility towards content that is disseminated by independent 3rd parties — even if it happens on the brand’s own facebook page/blog/forum, etc. “…a firm generally is not responsible for UGC [user-generated content] that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular). FDA will not ralph lauren polo women ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.”

4. You can (cautiously) start your social media engines: Once a brand launches an interactive channel, it does not have to submit content for FDA review before it is disseminated through that channel, which further opens up the opportunity for brands to do real-time engagement (e.g. respond to Facebook posts, comment on a blog). The FDA makes it clear, however, that companies must collate all content they have developed and submit for review on a monthly basis.

Other key highlights from the guidelines center on the importance of transparency http://www.pureyeti.com.au/ when engaging in 3rd party channels as well as the continued need for fair balance in all product communications issued by the company, regardless of where these communications are disseminated. Finally, the document outlines the specific process, protocol and forms required for submitting all this content to the FDA.

Knowing that this draft guidance is actually part of a broader set of guidelines that the FDA will continue to release through July 2014 should provide some hope for brand teams. With the issuance of this first draft, it seems the FDA bit off the easiest and most manageable chunk first, but it will be important to continue to watch how these develop and evolve over time.

In 2013, the United States Food and Drug Administration (FDA) approved 27 new drugs.

Many of those with a vested interest in healthcare, especially investors and analysts, view that number as “a barometer of industry innovation and the federal government’s efficiency in reviewing new therapies” as Matthew Perrone wrote for the Associated Press.

And compared to 2012, when the FDA approved 39 new therapies, some investors, analysts, and journalists are sounding the alarm bell about this decline in new drugs approved and what it means for pharmaceutical research and development.

Case in point: John Carroll, writing for Fierce Biotech, argues that the 27 new drugs approved in 2013 represent an “ominous” trend that “that once again raises big questions about the productivity and sustainability of the world’s multibillion-dollar R&D business.

Yet in my view, using the number of new drug approvals to measure the success of pharmaceutical companies is short-sighted. Don’t get me wrong – Carroll argues later in his article that 2013 was actually a good year for drug companies overall. But as we head into 2014, it’s important to look back at the broader landscape and achievements of both FDA and biotechnology and biopharmaceutical companies. Here are three trends that I hope continue in 2014.

  1. Fewer approvals doesn’t mean less revenue: According to the industry publication EP Vantage, combined revenues from drugs approved in 2013 represent an estimated $18.7 billion, easily beating last year’s projection of $16.4 billion.  The Wall Street Journal also noted that sales of drugs in company pipelines “are expected to more than offset the drag from pills losing patent protection in coming years.”
  2. “Me-too” drugs are going by the wayside: Innovative, life-saving drugs are coming to the forefront, especially for hard-to-treat conditions and rare diseases. In fact, one-third of drug approvals last year were for rare diseases. Biogen Idec won approval for its multiple sclerosis drug Tecfidera, Gilead got the nod for Solvaldi for Hepatitis C, and Roche’s Gazyva received approval for chronic lymphocytic leukemia. This is truly great news for patients.
  3. Innovative therapies are also coming to market more quickly: The FDA’s breakthrough therapy designation (BTD), along with adequate funding for the agency, is working. Drug makers, FDA, investors, and, most importantly, patients, are all benefitting.  The BTD, awarded to drugs that may treat a serious or life threatening disease or condition or show strong clinical evidence of an improvement over existing therapies, went into effect in 2012. Last year, only three products were approved with this designation. However, the FDA has granted BTD status to 37 compounds, according to Leerink Swann, and represents a “big influence” on investors.

Of course, the macro R&D landscape isn’t without its challenges. One that I’ll be especially interested to see in 2014 is whether, as The Wall Street Journal suggests, there’s a slight shift this year away from oncology drugs to other areas of unmet need, which I’d argue suffered last year.

In 2013, oncologic drugs, by my count, represented almost 30% of total approvals. Yet according to Barclays, one-third of R&D spending is going towards oncology and inflammation even though they account for less than 17% of total projected revenues. Drugs for cardiovascular disease and neurological illnesses together comprised only 18% of all drugs approved. Deutsche Bank has said that drugs for schizophrenia and depression form a $33 billion market, with investors willing to tolerate the high-risk nature of R&D for these products.

So, what do you hope to see from industry and FDA in 2014? I’d love to hear your thoughts.

Today, FDA held a tweetchat to provide further clarity and answers around its guidance on mobile medical app regulation. The basic takeaway on the guidance (which can be found here) is … it’s good! It’s clear! It’s pro-innovation! That’s great for companies and developers, but doesn’t make for a very exciting Twitter exchange.

Essentially the types of medical apps the FDA intends to regulate are largely unchanged from the draft guidance, but impressively the areas where FDA intends to exercise enforcement discretion – in effect, a hands-off policy – are significantly expanded. As you may have read in my colleague, Brian Reid’s blog post on Sept. 24, big pharma and health care solution providers will, for the most part, be able to develop away with little interference.

Apps that help patients manage their own condition (without providing specific treatment suggestions), organize their personal health information, provide access to information regarding their condition or treatment, help them communicate potential medical conditions to care providers, automate tasks for care providers or enable patients to interact with their personal health records or electronic health records are all fair game.

And FDA certainly had its talking points down, per @FDADeviceInfo: “FDA’s final MobMed guidance supports innovation & protects consumers”. That was a message that got repeated.

FDA did provide a little more color around its philosophy:
• “Enforcement discretion” = FDA is not actively enforcing requirements for manufacturers to register and list with the FDA
• FDA will review apps in a way that balances risks/benefits without creating unnecessary burden for app developers
• The FDA guidance reflects its focused priorities on apps that pose greater risks to patients & is a big de-regulatory action
• Apps that require FDA review will be evaluated according the same risk-based system the agency applies to other medical devices

A brief recap of select Q&A from the tweetchat can be found below. The full tweetchat can be reviewed online at Twitter.com, #FDAapps:

Q. How will FDA be monitoring apps for compliance? Browsing the Apple/Google Play stores?
FDA: Our efforts are focused on education and clarity at this time; we are focusing on clarifying areas that need oversight and looking for voluntary compliance.

Q. Logging and recording data seems to be fine, but what about interpreting data and making care recommendations?
FDA: Apps that meet definition of a medical device but pose little risk to consumers are an area where the FDA is exercising “enforcement discretion”; however, making recommendations that change dosage would raise risk to consumers.

Q. Some dosing apps are simple calculations routinely used in clinical practice. Will FDA exercise enforcement discretion for them?
FDA: Yes – please see appendix B in guidance (pg. 23).

Q. Under what circumstances would FDA choose to alter its enforcement discretion paradigm as explained in the guidance?
FDA: We intend to follow this [enforcement discretion] policy unless we have new info that raises public health risk. If/when we change policies we will follow public processes.

Q. Is the FDA checking apps’ algorithms and/ or checking validation/evaluation of apps?
FDA: It depends on the risk of the device & patient exposure. With regards to functionality, it would be similar to other high risk development.

Q. Is there a time at which you hope to transition to another phase–one of enforcement and action?
FDA: We will allow reasonable time for app developers to be into compliance prior to enforcement actions.

Q. How long does app rev/approval typically take?
FDA: On average, it has taken 67 days for clearance but it depends on the complexity and functionality of the app.

Q. Approximately how many ‘clearances’ of apps are we talking about up till now?
FDA: The FDA has cleared about 100 mobile medical apps over the last 10 years

Other resources:
• For questions about a specific app, please email: mobilemedicalapps@fda.hhs.gov
• Health professionals & consumers may submit reports of mobile medical app adverse events or problems to FDA online & by phone @ 1-800-FDA-1088

Joey_Fleury


Joey_verticalJoey is a Senior Account Manager and cross-functional player on our corporate/investor relations and product communications teams. But she’s more than that… Joey is also our Person-in-Portland (Oregon). She started working for W2O Group in San Francisco more than five years ago and moved up north for a change of scenery in 2010.

Luckily for us, she squeezes in regular visits to SF, in-between leading social media consumer campaigns and her other high-profile communications responsibilities—announcing pivotal trial results, new product approvals, quarterly financial results and strategic partnerships.

 

What is your role at BrewLife?

I cover investor relations, strategic writing, collateral development, media event planning, and much, much more. But my specialty is bridging corporate and product communications for healthcare and biotechnology companies. I enjoy spreading the word about clients’ value to investors, advocates, media and physicians. I have firsthand experience across the spectrum of clinical trial situations from binary data readouts (both the good and the bad) to FDA approval and even recall, and I have the battle wounds, and learnings, to prove it.

 

What keeps you returning to the office every day?

I was drawn to healthcare because of the human element. I find it rewarding to interview patients, hear about the awesome ways clients are helping them and tell their stories. Social media is providing exciting opportunities to reach patients where they live and offer valuable information. At the end of the day, it is all about the patients.   

 

What is your mantra?

“The devil is in the details.” It’s a given that big picture thinking is important but often forgotten that someone needs to plan for every detail to implement successfully. At the J.P. Morgan Healthcare Conference each year, I’m the central hub for all of our clients and employees—managing the details of everything from organizing a cocktail reception to making sure everyone has what they need.

 

What experiences contribute to your success?

I double-majored in Finance and Public Relations at Syracuse so a business perspective comes naturally to me. I’ve leaned on this background to help immerse myself in the numbers behind my client’s business.

 

What would you be doing if not this?

Living in beautiful Australia with my dog Cooper. And maybe going to culinary school. 

 

What’s fueling you today?

A juicy peach I picked up at a California farm stand.

 

Quick. Word association. What are two words from the FDA that healthcare marketers and communicators almost universally fear and dread?

The answer: Warning Letter (but I’ll admit “not approved” is also at the top of the list!)

For those unfamiliar, the FDA, and in this case the Office of Prescription Drug Promotion (OPDP) issues warning letters when a company or organization insufficiently or inaccurately communicates a medical product or device’s benefits and risks. This includes not fully describing the side effects associated with a product or using language or visuals that imply a product treats a certain condition which the FDA has not approved. A warning letter is what it sounds like; a cautionary notice – “Strike 1” to use a baseball analogy – from the FDA that a company should consider revising its communications to avoid enforcement action.

Of course, Warning Letters can be viewed through different lenses, with the chance for confusion. It’s like the batter who thinks he’s received ball four when the umpire calls strike 3. Different interpretations and views of the information, and the warning letters themselves, in healthcare communications can seriously impact future marketing efforts much like disagreements over the strike zone can affect a game’s outcome.

Luckily, the FDA does not issue warning letters without explanation or allowing for questions. Today at 11:30 a.m. ET, the OPDP will host an Enforcement Webinar that lets viewers directly communicate questions on Warning Letters and Untitled Letters November 2012 through March 2013.

During this time, the FDA issued six Untitled Letters for misleading claims about the efficacy or risks associated with products treating a variety of diseases and conditions.

Here are the three questions that I’d like the OPDP to answer today:

  • Looking forward, do you have a sense of particular areas of concern when it comes to trends you’ve seen with drug promotion? For example, are you seeing more violations in terms of overstating efficacy claims or understanding potential risks?
  • There was only one online letter dealing with a company’s web site and podcast. What are your primary concerns regarding potential violations on digital platforms? Where do you see the biggest risk for sponsors?
  • How do you plan to include the information you’ve used for these Untitled Letters in whatever policy FDA eventually issues regarding social media promotion?

I’ll be live-tweeting tomorrow’s meeting using the hashtag #FDAletters. Please follow along and look for another update on this blog later this week. And if you have additional questions for the FDA, please leave them in the comments section. I’d love to see them.

NextWorks’s Matt Snodgrass speaks with Chris Iafolla, Director at Twist Marketing, about the recent guidelines issued by the FTC regarding clear disclosures in advertising. This updates existing rules that have been in place for more than 10 years and now broadens the scope to cover social media and smartphones.

For watchers of the U.S. Food and Drug Administration, the question of whether a new year will bring solid social media guidelines has become as much a part of December as peppermint bark and “Grandma Got Run Over by a Reindeer.” So will the FDA act in 2013?

In November, the answer was “yes”: “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.” (Drug Industry Daily)

In August, the answer was also “yes”: “Social media ‘high priority’ for FDA 2012, despite lack of 2012 guidance.” (Scrip)

In June 2011, the agency said it was poised to act: “Tom Abrams, director of FDA’s Division (soon to be Office) of Drug Marketing, Advertising & Communications (DDMAC), said that publishing social media guidelines for industry is the division’s “highest priority.” (PharmaExecBlog)

The FDA said it was ready in March 2011, too: “Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities.” (FDA email)

And two years ago, in December 2010, guidance was imminent: “Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011.” (FDA email)

Of course, this was all kicked off in November 2009, when the agency held a two-day meeting on social media that was capped by a firm commitment to come up with rules: Social media guidelines are “important and we will do it.” Tom Abrams, Director, Division of Drug Marketing, Advertising, and Communications (FDA Public Meeting, page 450)

I don’t mention the historical record to suggest that 2013 won’t be the year where some pressing questions are answered (though the agency is working against a summer 2014 congressional deadline). Clearly, whatever the communications concerns that prompted the original FDA meeting in 2009 have only grown more clear, and some sort of action will come, either dramatically or more gradually. But, as the past few years shows, the tea leaves remain hard to read.

So what should companies be doing in the meantime? The advice remains almost unchanged from what we were suggesting two years ago: move quickly — and cautiously — to build up social media chops in corporate and unbranded spaces, improve online monitoring and work to understand and engage with the new leaders in social media. And if you need help with that? Well, we’re standing by. Drop us a line.

Early this week, Scrip published an article that notes that the FDA still considers social media a “high priority,” even though the agency’s working list of topics in need of additional guidance hasn’t included social media in a couple of years.

It’s tempting to say that the FDA’s continued commitment to more explicit rules really doesn’t matter. At WCG, we’ve been consistent for years in our belief that no company need wait for the FDA before wading into social media. There are well-established, safe ways into interact online, and the simple act of setting up a blog or responding on Twitter is no longer causes eyebrows to arch or tongues to wag. (For an excellent example of how one large pharma company — that happens to be a client — is plunge ahead, check out Fast Company’s examination of Sanofi’s efforts.)

That doesn’t mean that there haven’t been consequences, and I outlined some of them last December. But most of my concerns from last year have been allayed, in part, by the rising number of successful case studies and trial-and-error advancement made by the pharma industry in moving forward (cautiously), even without rules.

But one of the consequences I didn’t talk about then was the impact of the FDA’s inaction on smaller companies: organizations that don’t have the legal support or regulatory know-how to test undefined waters. Though pharma is sprinting ahead in its exploration of this space, biotech companies remain laggards, and the smaller the company, the more resistance there is to implementing social media platforms without some sort of solid direction from the FDA.

Increasingly, these are the groups that need guidance the most: more and more of the important conversations — among patients, among investors, among doctors — is taking place online. And while my colleagues at WCG can certainly present options and show how others have done it safely, there is no stack of case studies high enough to outweigh the positive impact of FDA action.

So this week’s news that the FDA still “committed to this area in terms of both time and human resources”, could mean good things around the corner. Especially for those who need it the most.

“The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.”

That’s one of the final lines of Senate bill 3187, which passed the Senate 96 to 1 yesterday, and is expected to easily pass in the House. The bill is also known as the “Food and Drug Administration Safety and Innovation Act” or — more importantly — PDUFA V, the fifth installment of the early-1990s regulatory change that forever altered the Food and Drug Administration. It’s an important line, and this is an important piece of legislation. Here’s why:

PDUFA, the Prescription Drug User Fee Act, was first passed in 1992 and it set up the drug regulatory system we have today: companies pay “user fees” to the government, and the FDA works to review drugs in a timely fashion. The initial law had a revolutionary effect, ramping up approval times and changing the FDA from a plodding bureaucracy, often behind the rest of the world in approving new products, into a far more efficient regulatory machine.

PDUFA must be renewed every 5 years, and each iteration has brought subtle changes. The last two iterations focused on making the agency more safety-conscious, boosting the agency’s funding to spot unexpected adverse events. But this go-round, the focus has been on making the agency more patient-centric.

It’s not just that the FDA will start implementing “strategies to solicit the views of patients.” They’re changing the rules to bring drugs to populations with serious and life-threatening diseases, bringing a regulatory pathway already in place for cancer and HIV drugs to a much broader group of diseases.

While the specifics of the bill will no doubt change the way that industry interacts with industry, the explicit inclusion of patients should be of more general interest to those of us in health communications. It is yet another acknowledgment of the welcome trend of ensuring that patient voices are a part of the dialogue around public health.

Just as medical meetings and others are beginning to recognize the importance of the patient perspective, the FDA will also be amping up the attention they pay to this hugely important group. That means that communications firms and companies that ignore what patients are saying will be depriving themselves of counsel that will be informing the direction of modern medicine. And while building relationships between patients and industry is not without issues (many of which were discussed at the “Friending Pharma” SXSW panel), such issues must be addressed head-on to ensure open communication between every part of the health care system.

Because we know the FDA will be listening. We cannot afford to do any less.

Imagine, for a moment, that you are a cancer patient in an examination room. Your doctor enters and tells you that there are two treatment options. One assures you of 18 additional months of survival, but no more. The other will either extend your life by 3 years, or not at all. Which option do you choose?

In most areas of life, people opt for the sure bet. Approach someone on the street and tell them you’ll hand them $150 — or let them flip a coin, double-or-nothing — and they’ll take the $150. But when it comes to cancer care, a survey of cancer patients found that 77 percent would take the 50/50 gamble on getting three extra years of survival, according to research in the latest edition of the journal Health Affairs.

While the paper delves into detail on why, exactly, we seem more likely to take what the authors call a “hopeful gamble” (patients with short life expectancy may feel that they have less to lose), the results are important to health communicators for another reason: it gives insight into the way that patients themselves want to choose treatments, and how patients view statistical descriptions of a drug’s effectiveness.

In the hypothetical presented in the Health Affairs paper, both of the fictional drugs had exactly the same median overall survival: 18 months. From a strictly statistical point of view (and from the point of view of the U.S. Food and Drug Administration), the two medications are identical, despite the fact that deaths are clustered in two vastly different ways. But just because they are indistinguishable to the statistician does mean that a patient would see no difference. Indeed, patients in the study said that not only did they prefer taking the hopeful gamble, a quarter of the breast cancer patients surveyed said they’d be willing to pay an extra $90,000 for the opportunity to flip the coin. The value of the gamble far outstrips that of the safe bet, for the patient anyway.

It’s a reminder that though it’s important to talk about median survival, which remains the gold standard for regulators, we do patients a service when communication about a drug’s efficacy includes other metrics, such as the percentage of patients alive after a given number of years, that might help quantify how much hope is built into those survival statistics. With that need for additional information comes addition responsibilities — patients examining a hopeful gamble need to understand the consequences when the gamble doesn’t pay off — but it’s clear from the Health Affairs paper that patients value that information. Our job, as communicators, is to make sure they get it.

Here at WCG, we’ve long been advocates for the idea that biopharma companies should not wait around for the Food and Drug Administration to codify super-precise social media rules before using new technologies. While there are some specific points of clarification that the agency would vastly simplify our lives, there is no question that a convention wisdom has emerged that points to a safe way to engage on social media.

But it’s one thing to talk about “a conventional wisdom,” and quite another to specifically detail an emerging set of best practices. We have created our own set of next practices (contact us to learn more), but — increasingly — the areas of consensus are becoming publicly outlined with more precision.

One of the notable attempts is coming out of the Digital Health Coalition, a non-profit that counts industry, patients, docs, tech companies and others among its membership. Earlier this month, they outlined seven “Guiding Principles” for how regulated health care companies should approach social media.

None of the seven principles are particularly edgy: They call for companies to be transparent and forthcoming with information and they note the importance of reporting adverse events and correcting misinformation. They make clear that companies shouldn’t be responsible for information they didn’t create or control, and they encourage a patient-centric approach to online. But the lack of an edge is exactly the point. This defines the common-sense approach to online social media use by biopharma.

The “Guiding Principles” are not a detailed road map. At fewer than 225 words, the document is a 30,000-foot view at best. But it gives everyone — including, I hope, the FDA — a starting point to build from. There’s no question that biopharma is behind when it comes to digital, but the industry pioneers have closed the gap quickly. And with more attention and more collaboration, the digital revolution will only pick up more steam, FDA or no FDA.

This Groundhog’s Day, Punxsutawney Phil saw his shadow, suggesting the unseasonably warm season might be taking a turn for the frigid. Nowhere has it been hotter this year than in the life science industry, which saw blazing Food and Drug Administration approvals of a handful of new, game-changing drugs. But unlikely the weather on the Eastern seaboard, it’s unlikely that the groundhog will bring a big chill to biopharma.

What made January extraordinary for drugmakers was not merely the speed with which the FDA acted (at least two were approved well ahead of the agency’s deadlines), but the fact that the highestprofile of the major approvals came in so-called orphan diseases, which affect less than 200,000 patients and can afford developers additional market exclusivity.

The trend of serving smaller patient populations with more targeted drugs is almost certainly going to increase, thanks to better technology and an better-understood business model for serving smaller groups. The best evidence for this the number of drugs for which orphan designation was granted. For years, this number hovered in the double-digits. Then, in 2004, 133 drugs were given orphan status. Last year, 199 made the cut. If the trend holds, we’ll top 200 in 2012. (See chart.)

And this is a leading indicator: many of these drugs are years from getting an FDA nod. But the number of approvals is rising, too. A record number of orphan indications — 26 — got FDA approval last year, and it’s not a stretch to think that that number will rise, too.

The race to explore orphan indications marks a fundamental shift in the way breakthrough therapies are introduced. The number of drugs that are aimed at populations of millions and millions are shrinking. And while we won’t see the end of primary-care-driven blockbusters, they will certainly become more rare. That’s going to mean a move for those in communication to get closer to the smaller patient and provider populations: less flashy celebs, fewer DTC ads, more emphasis on trade publications and narrow online communities.

It’s always dangerous to make large conclusions out of a few data points. Regression to the mean means that it will get cold again. And the FDA isn’t likely to have many weeks where they sign off on three new drugs. But the surging number of orphan designations means that — over the long term — the orphan drug climate is likely to stay hot, no matter what the groundhog says.

http://sentw2ogroup.wpengine.com/wp-content/uploads/2012/02/Orphan-Chart.png

The Food and Drug Administration, last week, pushed out guidance on how companies may respond to inquiries about off-label use of marketing drugs and devices, reaffirming a policy that’s been in place for at least a quarter-century. The document includes a discussion of a number of different arenas in which information in shared, including online outlets. **

As a result — in a fitting reflection of how starved people are for rules governing the use of new media technology – the document has been widely referred to as the FDA’s “social media guidance.” AdAge’s headline called them “Social-Media ‘Guidelines” in a widely cited piece. Slate’s headline used “Draft Guidance on Social Media.” FiercePharma’s headline talked about “sharing in social media.”

Though the excitement is forgivable, the headlines are not quite right. None of the larger philosophical questions about social media were addressed. None of the impacts of FDA inaction I wrote about last month have been ameliorated. It’s hard to imagine any large-scale changes in approach based on this document. Indeed, to the extent that the new guidance is helpful, it is in codifying a set of policies that are already in place.

What the FDA published last week is not social media guidance. It is merely guidance that mentions social media, or — in FDA’s parlance — “emerging electronic media.” It uses the words “YouTube” (once) and “Twitter” (once) and “blog” (once). The lack of ambition was skewered by former Merck policy guru Ian Spatz, who called the document “a belated lump of coal” on Twitter.

But even if the guidance doesn’t change the rules on social media, there is reason for optimism. The FDA is clearly conversant in digital media strategies and the new rules suggest an understanding of the way that companies are operating in the online space. When it comes to the narrow topic of unsolicited off-label communication, the agency did a thoughtful job of including a broad range of potential communication scenarios, from YouTube contests to public medical meetings. If all future guidance is as inclusive, we’ll begin to see the outlines of a coherent communications framework. Eventually.

Of course, the alternative is that the FDA could pull back the curtain on that framework even faster. Now that would be headline-worthy.

** WCG clients: We’ve done a brief analysis of the implications of the new guidance for both real-world and on-line communications. Please talk to your client partner if you’d like to learn more.

A year ago, FDA junkies were closely watching for promised guidance on how the agency would approach social media. There was a year-end deadline, and much debate over how much (or how little) those new rules would change the approaches that drugmakers took. But we rang in 2011 with no guidance, and the revised deadline of March 30 also came and went with no action, and there is less and less evidence that the agency will ever act.FDA logo

Looking back, the lack of guidance might have had as big an impact as actual FDA action would have. There are 5 major consequences of the FDA decision not to move ahead:

  1. Branded promotion has been stunted. Branded promotion online exists, but it has yet to flower, for the simple reason that the risk of being accused of improper marketing far outstrips the benefit of educating doctors and patients. The lack of guidance only inflates this perception of risk and stems the flow of creative ideas.
  2. Unbranded promotion has been delayed. There are some excellent examples of pharmaceutical companies doing great, creative work online that is providing clear and obvious benefit to the health care system (including some great work by our clients), but these pilot efforts could have been blooming two (or more!) years ago. Instead, fear and uncertainly slowed their trajectory. Now that industry has figured it out on their own, guidance might not have a huge impact.
  3. The public health has (probably) been harmed. While pharma companies — which arguable have more expertise in certain arenas of health care than any other organization — have been shackled on social media, there continues a rising tide of pseudo-science and fearmongering online. The best way to fight lousy information is with good information. Restricting the ability of industry to join this conversation has been a net benefit to those who with an anti-science agenda. (This was at the heart of an analysis that my WCG colleagues presented to the FDA more than 2 years ago.)
  4. Basic questions remain unanswered. No one expected comprehensive guidance, but there has always been hope that the FDA would weigh in on some specific questions, such as whether — in a character-limited environment (Twitter, AdWords, etc.) — pharma companies were required to include or link to an entire package insert. Companies have made their best guesses, but, after years of study, only the FDA knows for sure what the rules are.
  5. The agency has opened itself to charges of hypocrisy. The FDA has itself become increasingly skilled with its use of social media tools, even as they refused to push out guidance. It creates an unusual and ironic playing field: the FDA has great latitude to use modern communication tools to inform the public through a variety of channels, but it has stymied the industry’s ability to follow suit.

Though I have long been a skeptic that FDA guidance would be a magic elixir for industry, there’s no question that it has caused some damage, and that some of that damage can’t be undone. Still, the optimist in me wonders if this could still be the year. It is too much to hope for the FDA as social media Santa this year?

We’re all aware that, in the U.S., when a regulated drug is mentioned in the same breath as the disease state or therapeutic area for which it’s prescribed, that statement must be balanced with information about the drug, which may include side effects or warnings. This fair balance statement typically takes the form of an ISI or Important Safety Information.

In print media, such as magazines, this fair balance is usually shown on the back side of a drug advertisement. You know … the fine print you see on the next page of the magazine. On TV, some of the main safety information is spoken in a voice-over, and then the viewer is often directed to more information in a magazine ad or website. On a website, the ISI is presented on the same Web page as the drug name, as long as it’s above the fold (unofficially).

In those media, the presentation of these messages goes through rigorous review and approval from medical, legal, and regulatory teams at the pharmaceutical company and are then submitted to FDA, specifically DDMAC, for review. The million-dollar question is, what to do in social media? How does a pharmaceutical company present Important Safety Information in a medium that is both real-time and condensed?

Nearly all of the major social media platforms present a challenge to mentioning both a drug name and the disease it’s used for while allowing for an ISI. Let’s take a look …

Twitter

  • Challenge: With only 140 characters to relay any information, an ISI would certainly not fit within a Tweet.
  • Solution: Don’t mention a drug name and what it’s used for — simple as that. A link to the ISI has proven still unsatisfactory for current guidelines. One company, Novo Nordisk, put the ISI for Levemir and NovoLog as the image background to their @racewithinsulin Twitter profile page. However, the two problems with that are that the ISI is not text at that point, so it can’t be “read” by computers of those who are visually impaired, and Twitter’s updated format now covers the ISI. But I applaud their efforts.

YouTube

  • Challenge: Both the video content and the Web page on which it’s presented must show the ISI, if the video and text on the page contain the drug name and the disease.
  • Solution: For the video itself, be sure that the ISI is edited into the end of the video, either scrolling or as a series of still text cards. If the title and/or description of the video also contains the drug name/disease, then the ISI must also be shown on the Page. This cannot be done with a standard channel (the free kind). If you wish to do this, you must pay for a Brand Channel. A Brand Channel will cost you, but it also affords your videos more promotion within YouTube.

Facebook

  • Challenge: In short posts, you can’t include a long ISI in each and every post. Also, there’s no editable space on a Facebook Web page to insert an ISI.
  • Solution: You can create a custom tab that has the full ISI in it, and you can make that tab the default landing tab. I’ve also seen where one company posts the full ISI as every 5th post, so it remains above the fold. Even if Facebook were to allow some space for an ISI on a Page, the number of characters needed for an ISI are much greater than the hallowed page space that Facebook may be willing to allocate.

In each of these social media platforms, you would need a lot of space to show the full ISI. If a platform affords you 75, 140, or even 1,000 characters, that may not be enough. Below are the character lengths of the ISIs for the top-selling drugs in the U.S.

Drug Name

ISI Character Count

Lipitor®

1,473

Nexium®

1,791

Plavix®

896

Advair Diskus®

887

Abilify®

5,779

Seroquel®

4,721

Singulair®

1,089

Crestor®

746

Actos®

3,688

Epogen®

4,973