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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.