Notes from the Back of the Book

Pharma: Seven Tips To Improve Your Next FDA Advisory Presentation

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Yesterday, I posted my key takeaways from last week's FDA advisory meeting for Social Media and Internet Marketing #fdasm ("Ask Not What Social Media Can Do For You"). Today, I'm providing food for thought for how presenters can improve their impact with an FDA advisory board. This is based on watching the 77 presentations last week, and having recently participated in the FDA Risk Communications Advisory Meeting this past February.

Building on a previous post: "Pharma: No More Bullets Please", here are seven points that can help improve your next presentation to an FDA advisory committee. (These tips will also apply to other important upcoming presentations)

1. Build your story around data. FDA is a data driven entity-it's in their bones. A story without data reference simply lacks punch for any FDA advisory board. It's the "reasons to believe" so essential to any communication.

2. Don't just repeat what FDA already knows; provide clear recommendation(s) including potential solutions, guidelines or unique construct(s) that can help with advancing policy. If FDA is holding the advisory meeting, it means that they largely recognize, and hopefully understand, much of the background and problem, and are looking for ways to move learning and policy forward. Data that leads to a concrete construct is the perfect combination. See if your solution can't work to sell a dream-that can help FDA take a step closer to its mission of better patient education and health.

3. An FDA advisory board is made up of people and people respond best to a good story. We can take some lessons from Steve Jobs, one of the great presenters. Introduce an antagonist. Every presentation is a theatrical experience: "Every great drama has a hero and a villain." Steve Jobs explains the problem and leads the way for the hero...Create a common enemy... lead with a strong beginning, middle and end. (If you haven't watched ABC's video: The Secrets of Steve Jobs, you may want to take a few minutes to do so here).

Spend the time upfront to think about how your data and expertise can lend themselves to a unique and compelling story that the FDA will thank you for. And of course, it goes without saying, that your story must answer their needs and not yours. If you honestly can't answer why the FDA should want to listen to you, don't present!

4. If you've read point #3, and you are telling a good story from the FDA's perspective, and not your own, then you know that this presentation is NOT a sales call or another Biz Development opportunity! Keep your presentation focused on fueling the FDA's learning and research for developing healthcare policy. In other words, add value or die! (not literally of course)

5. Think about "Twitter-friendly headlines". Give your key solution a simple name and a short and concise descriptive headline or sound bite e.g. macbookair-"The Worlds's Thinnest Notebook". Two examples from #fdasm might be Rohit Bhargava of Oglivy 360 with his 3 C's for defining when a pharmaco is responsible for content, or Wendy Blackburn with her Rx Risk red button.

6. Use slides to help reinforce your points, but only if slides are simple and readable! The experts recommend practicing Zen like simplicity - ‘the elimination of clutter'. (From my own experience, I know it's easier said than done.) Unfortunately, more presenters than I can count, including many agency ‘communication experts', used slides that were difficult to read, packed with too much data to take in or read, and too many competing points. If you have to apologize about a slide, fix it BEFORE the presentation! Your written submission is the place for all the data specifics and detail-- not your ten minute presentation and slide support.

7. Relentless practice. It's the only way to connect with your audience and speak most confidently. The best presenters in the world NEVER skip this step, and spend just as much time rehearsing as creating (maybe more). Just watch any Ted presentation...

If you haven't watched Pixels and Pills interview with Tom Abrams, presiding officer of the FDA advisory meeting, watch his video. It will reinforce many of the points above.

Our EXCLUSIVE Interview with Thomas Abrams at the FDA Hearings from Zemoga on Vimeo.

Importantly, if you presented at last week's FDA social media hearing, thank you.  There were many excellent presentations that were spot on. Please consider these suggestions as potential input for your next presentation...

Looking to stay current with the latest happenings on FDASM? Visit www.fdasm.com, created by Ignite Health.

Pharma: Ask Not What Social Media Can Do For You, But What Your SM Can Do For Patient Health

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Last week, I and a few hundred other SM-aniacs, spent  2-days in the #FDASM 'bunker'-so nick-named for its lack of windows and web/cell phone coverage. (Many more also attended via a free webcast and live twitter.)

Shortly after the program began, I heard a faint voice in the back of my mind. At first I couldn't place the voice or make out the words.  But it grew louder with each presentation. On the train home, I recognized the voice as JFK's, and the words as his inaugural speech "Ask Not What Your Country Can Do".

If you haven't read JFK's short but powerful speech, do yourself a favor and read now.  I think you may be struck by the parallels between the challenges he faced and the vision he articulated to meet them, and the challenges we must rise to as pharmaceutical and social media professionals trying to keep up with empowered e-patients in a web 2.0 world, soon to be web 3.0.   

Here are some of the challenges JFK articulated in his speech that seem particularly relevant to our challenges of engaging and educating patients and doctors using rapidly evolving technologies and strategies. I'll also do my best to link back to the many speakers and presentations from #fdasm.

"The world is very different now..."

• Fact after fact, presentation after presentation, reinforced the exponential growth of the web as a critical information source for healthcare education and community building...Some of my favorite factoids:
• Google pointed out that during just the last 3 months of 2007 there were 4.6 billion searches using healthcare terms made by 111 million people and that healthcare searches are growing exponentially. They also provided examples of how access to information on the Internet can be a public health plus (Read Senak's eyeonfda blog)
• Pew's survey reports that 61% of Americans look online for health information-these are the e-Patients of today. And 37% of adults- or 60% of e-patients- have accessed user-generated health information.
• Manhattan Research: 35% of adults use social media for medical information which equates to 80 million health 2.0 consumers. Mark Bard also presented data on physician web 2.0 use
• In addition to the sheer volume of online health activity, consumers are searching and interacting with one another in highly specific targeted ways. For example, Health Central's quick review of various social media sources last month, found: there are more than 100,000 people on Facebook diabetes groups, there were recently nearly 500 posts on ADHD in a 24- hour period on Twitter, and more than 201,000 searches on "Concerta" in September on Google, more than 40,500 searches for "Cymbalta side effects" in September on Google etc
• However, I hope this means that Pharma can now put all the 'web selling' and 'can you top this fact' finding behind us in favor of identifying and exploring solutions to more effectively engage web 2.0 platforms.
• Web 2.0 and social media platforms have engendered new consumer expectations. 'Selling' is not always welcome in the web 2.0 and 3.0 world. Patients are looking for value-added knowledge- when and howthey want it-notwhen and how the pharma co. (or FDA)wants topresentit. To many e-Patients, selling clearly comes after information and value exchange, but pharmacos should be part of the conversations. Jack Barrette of WEGO Health presented survey data from their patient advocates to this effect. (Q1,2, 3, Q5) (I also suggest reading Patient DC's blog for another e-patient perspective.) Interestingly, physicians also demand a different voice and engagement when they are using social media sites, as presented by both Sermo and Pfizer's Freda Lewis-Hall.
• New information sources, including wikipedia, blogs, chat rooms, and sites like WEGO are establishing new influencers and thought leaders that Pharma and FDA need to consider and engage. However, while Wikipedia is a vastsource of information for consumers, its contentis not 'controlled' by FDA or pharma. Nor are the many e-patient/caregiver blogs and community sites. This means that user generated content (UGC) is inconsistent at best and often incorrect or biased. Importantly, however, the patient advocates at WEGO Health reported that they expect pharma to make their ‘best effort' to monitor and correct ‘incorrect or biased' third party UGC and to monitor adverse events, despite their rational knowledge that monitoring the entire web is impossible.

"But neither can two great and powerful groups take comfort from our present course - both sides overburdened..."

• Neither Pharma/device marketers or the FDA can move forward without developing guidelines or 'guard rails' to enable faster and more effective uptake of social media platforms and tools. (Michele Sharp of Lilly) However, many speakers, including Liz Forminard and Philomena McArthurx at J&J made the case that guidelines must remain flexible. (Read Marc Monseau's blog at JNJBTW)
• Moreover, current communications are often burdened with so much technical and legal language that the average consumer cannot understand or be sufficiently motivated to make the effort to read and comprehend risk and safety information. Cadient highlighted the fact that 30 million Americans are health illiterate. Research has shown that education levels required to understand and comprehend the average ISI and PI is some college education and post-graduate education, respectively.
• This is a case where ‘more is not necessarily better'. More work is clearly needed to "radically simplify" risk language so that it's more consumer friendly, and to better educate the public for the need to report adverse events. Many speakers recommended the urgent need for new and simplified consumer risk language, and/or an easy to use ‘FDA approved' patient symbol to signal quality accurate content, and/or an easier to use and more patient-friendly MedWatch initiative to insure higher levels of AE reporting, including PhRMA, Fard Johnmar, Wendy Blackburn RxRisk icon, Jonathan Richmond, John Mack, Bill Drummy, and Dr. Diana Zuckerman of the National Research Center for Women and Families. (You may also want to read my summary and presentation from the prior FDA Patient Risk Communications Advisory Meeting earlier this year.)

"So let us begin anew - remembering on both sides that civility is not a sign of weakness, and sincerity (and transparency) is always subject to proof. Let us never negotiate out of fear. (Or worse yet, adopt a strategy of avoidance out of fear) But let us never fear to negotiate."

• Transparency and the establishment of guidelines are needed to stop pharma from avoiding social media platforms out of fear of FDA. (Lilly, Global Prairie, J&J, Pfizer)
• Many expressed that the internet is a complex and different medium than TV and Print, and likewise requires unique adequate provision policy similar to how FDA approached DTC TV advertising back in 1997. Given the many different platforms and roles that the web plays, from search to advertising to 2-way interactions and UGC, specific web 2.0 guidelines need to be created and continuously updated. While for the most part, the message must stay the course across different media, there seemed to be recognition that the web's uniqueness requires some new thought and guidelines.
• New ways of looking at benefit and risk tradeoffs are required if we are to support and educate the consumer. Digitas presented research that showed that more risk information does not always result in greater risk comprehension if less consumers read it.
• On the accountability front, Oglivy 360 Digital Influence presented their 3 C's approach to help guide responsible marketing in the web 2.0 age: creation, collaboration and compensation. If the answer is yes to any of these three C's, then the pharmaco is responsible for its content.

"Let both sides explore what problems unite us instead of belaboring those problems which divide us"...

• We need to design ways to put the patient first. Both Google, Ignite Health and Intouch Solutions presented data that showed that the drop in paid search advertising has meant a huge drop in patient searches or click-thrus to higher quality FDA approved pharma.com sites and more...So while on the surface, the 14 letters may have seemed like a prudent idea, the result may be actually something less than preferred with less scrupulous and lower quality content filling the void.
• While FDA and pharmacos may differ on how they might approach the balance of benefit and risk information, they can unite behind the need to "radically" change the way that risk/benefit information is presented to improve comprehension, to provide consumers with a way to better know that risk information they are reading is accurate (many consumers don't check the source), and to encourage consumers to report AE's-as very few are ever reported.

Let both sides seek to invoke the wonders of science instead of its terrors. Together let us explore...

• There was much recognition for the continuous exploration of how to best conquer the fast evolving technology to help educate and instill more responsibility for patient health. Many speakers recommended that on-going committees be formed...
• Great quote by Peter Pitts, Center for Medicine for the Public Interest, "Social media is too important to hide in a cave. It is communication at THE speed of life." (via Roska Digital)
• Wrapping up the two-days, Tom Abrams, Presiding officer for the FDA hearing, reinforced not only the importance of the web to current and future healthcare policy, but that its complexity requires a very thoughtful exploration by FDA. (Watch Pixel and Pills exclusive interview with Thomas Abrams at the conclusion of the advisory meeting.)
  
  
  

And so, my fellow Pharma and Healthcare Marketers:

Ask not what Social Media can do for you - ask what your Social Media can do for patients... Ask what together we can do for the improvement of patient health...     

e-Patients of the world, ask of us the same high standards of strength and sacrifice, education and responsibility, which we ask of you...

Thoughts? Comments? Feedback?  While no meeting can solve the problems of the world, all and all, I think it was an excellent start. My sincere appreciation to all the presenters.

There are also many terrific blogs and summaries on the 2-day FDA Advisory Meeting: Shwen's Live from DC extensive list of #fdasm blogs, Pixels & Pills EXCLUSIVE Interview with Thomas Abrams at the FDA Hearing and others (Rohit Bhargava of Ogilvy PR 360, Peter Pitts, Jack Barrette of WEGO Health), A Patient Perspective by DCPatient,  John Mack, Mark Senak's EyeOnFDA, Roska Digital's numerous updates, and  Chris Truelove's wrap-up which also includes some good links-Yet more blogs and speaker presentations can be found at Fabio Gratton's fdasm.com. And for a list of good blogs leading up to the meeting, read my post: Twas the night before #fdasm.

Pharma: Twas the Night before #FDASM

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Twas the night before #fdasm, when all through the blogosphere,

Not a marketer was stirring, due to their fear.

The 62 slide decks were posted with care,

In hopes that St DDMAC soon would be there.

The pharma tweeps were nestled all snug in their beds,

While visions of facebook dance in the heads.

And legal in her ‘kerchief, and I in my cap,

Had just settled our brains for a long winter's nap.

When out on the web there arose such a buzz,

I sprang from the bed to see what the fuss was,

Away to my Google, I flew like a flash,

To find in my search fourteen letters to trash.

Despite the scurry that was sure to follow,

There were some brave pharma folk that tried to stay mellow.

For they realized that marketing was quickly evolving,

More rapid and urgent than patient dialogues were happening.

With a little old driver, wearing a bright red cap,

I knew in a tweet it must be St DDMAC.

More rapid than eagles his coursers they came,

And he tweeted and shouted, and called them by name!

"Now Lilly! Now, Oglivy! Now, Sanofi and WEGO!

On, PhRMA! On, Pfizer! On, comScore and Sermo!

To the top of the community! To the top of the wall!

Now dash away! Dash away! Dash away all!"

And then, in a twinkling, I heard on the roof

The prancing and pawing of each little hoof.

As I drew in my head, and was turning around,

Down the chimney St DDMAC came with a bound.

He was dressed in new media, from his head to his foot,

And his clothes were all tarnished with ashes and soot.

A bundle of Guidelines he had flung on his back,

And he looked like a hero, just opening his pack.

His eyes-how they twinkled! His dimples how merry!

He said when it comes to AE's don't worry!

A wink of his eye and a twist of his head,

Soon gave me to know I had nothing to dread.

He spoke not a word, but went straight to his work,

And filled all the stockings, then turned with a jerk.

SEM, twitter, video and facebook,

And giving a nod, up the chimney he did look!

He sprang to his sleigh, to his team gave a whistle,

And away they flew like the down of a thistle,

But I heard him exclaim, ‘ere he drove out of sight,

"Social Media to all, and all will be right!"

The FDA hearings have the potential to be a game-changer for our future and that of patients... 

I'm wishing all the presenters, many of which are my friends, good wishes over the next two days.

And here's to actionable guidelines "before the night before Christmas 2010!"

It's a busy week in Washington DC.  Also occurring on November 12-13 is an advisory meeting to discuss patient risk communication. You can read Eye on FDA's blog here. This is a follow-up to the advisory meeting back in February 2009. You can read my blog summary here.

Other blogs on #FDASM that you may want to read:

Eye on FDA: What if FDA threw a party and no one came?

Eye on FDA: Risk Communication Advisory Committee: The other FDA advisory meeting this week--don't ignore it!

Why Dot Pharma: FDA and Social Media: The first hole in the wall?

Wendy Blackburn:  A (Hypothetical) Letter to Consumers from Pharma

Dose of Digital: 166 Reportable Adverse Events Equals One Red Herring

FDA Social Media Hearings -- Output Might Confuse Consumers

Pharma Marketing: FDA Panelists at the Upcoming Social Media Public Hearing

Pharma Marketing:  PhRMA Proposes FDA-Approved Universal Safety Symbol

Visit Ignite Health's terrific site (fdasm.com) summarizing tweets, blogs and all FDA documents and presentations.  Thank you Fabio Gratton!

More to follow after the advisory meeting...

Are Pharma's Hands Tied with New FDA Draft Guidance for DTC?

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This week, the FDA issued a 24 page Draft Guidance for Industry presenting risk information in prescription drug and medical device promotion. The draft guidance provides numerous examples of print/tv/video to illustrate FDA's thinking on presenting risk information, and is equally applicable to presenting benefit claims.

However, the draft guidance does not address the unique features of sponsored links, banner ads, the subject line of e-mails to physicians or patients, or any other  social media or internet communications more generally. FDA  says in the Draft Guidance that the agency applies the same principles about risk disclosure in prescription drug advertising  to all promotional pieces, regardless of the medium used.

Overall, the draft guidance is  very consistent with prior guidelines and current industry practices.  Coming on the heels of  recent warning letters, the FDA has taken a 'more vs less' approach, providing concrete examples, but not in the area of web and social media that many of us were hoping for! Some key takeaways:

1. It's all about appropriate and effective risk and benefit communication; promotion that is designed to achieve a BALANCED risk/benefit presentation. (How often have we heard this before?)

2. FDA looks not just at specific risk-related statements, but at the NET IMPRESSION- i.e. the message communicated by all elements of the piece as a whole... (Again, this isn't new, but it's repeated throughout guidance.)

3. Content and format can contribute to a misleading net impression in promotional pieces; numerous examples are provided to help illustrate this. The FDA subscribes to the universal concept of communication and cognitive understanding of risk information which is why the draft guidance addresses both physician and consumer audiences. Additionally, unless specified, the principles outlined by FDA apply to all promotional pieces, regardless of the medium used or the target audience. (FDA has been signaling this in recent interviews for web and social media--"It's not the medium but the message."  Mark Senak's interview with Dr  J Kang)

4. The reasonable consumer standard used by FDA in evaluating promotional materials is similar to the FTC standard: They will examine reasonableness from the perspective of the group with which the promotion is targeted. FDA, like FTC, takes into account the different levels of expertise of lay consumers and healthcare professionals. However, research has shown that experts (in this case, healthcare professionals) are subject to the same cognitive biases and processing limitations as non-experts. The guidances discusses factors that can affect attention and comprehension. (This was very evident in the FDA Risk Communication Advisory Committee Meeting that I attended back in February 2009. This is still an area with  big opportunity for improvement: 'Less is more; simplify for the consumer')

General Considerations:

1. Consistent use of language appropriate for the target audience Ie. If benefit claims are presented in consumer friendly language then risk language should also be in similar consumer friendly language and not medical lingo.
2. Use of Signals (e.g. headlines in a print ad) should be consistent across benefit and risk information; content of signals are important too. FDA is looking for specific and clear signals vs  those that are vague or abstract.
3. Framing Risk Information with the same terms or with the same degree of specificity as benefit information.
4. Hierarchy of Risk Information--the most important risk information, including relevant warnings and contraindications, should be placed or stated first...

Considerations of Content

1. Quantity: As the amount of benefit information conveyed increases, the amount of  risk information conveyed should similarly increase. The amount of information presented is one component that, together with choice of words, color, graphics, voiceover, and other aspects of the piece, can affect cognitive load, the  mental effort required to understand the various components of information in the piece.  This suggests comparable treatment of the risk and benefit information in each piece. 
2. Materiality and Comprehensiveness: Material facts are those that would influence reasonable consumers (or healthcare professionals) about a product-such as: The relevant properties of a product, appropriateness for themselves or their patients, willingness to accept the risks or burdens associated with using or prescribing a product. 

Considerations of Format

To process information, a person must first pay attention to it. As a general matter, risk and benefit information should be comparably noticeable or conspicuous and able to be read with similar ease ( e.g., comparably legible and understanding)

Print Promotion--layout and formatting factors: 

1. Overall location of risk information should generally appear in the same parts of the piece as the benefits.
2. In addition to appearing with or near benefit information, risk information should appear as an integral part of the piece, just as benefit information does. (This is often called "peppering" by regulatory advisers and largely where J&J's Ultram ER got into trouble and received a recent warning letter for their video)
3. Font size and style that affect the prominence and readability of information
4. Contrast between text and background should not highlight the benefits more than the risks.
5. Use of White Space should be similar for risks vs benefits.

Non-Print Promotion

As with print, FDA considers factors such as location, proximity, type size and style, and contrast when evaluating videos or broadcast ads. But the FDA also evaluates other formatting factors such as audio components, motion within the visual component, the juxtaposition of visual and audio components, and duration of exposure.

1. Textual Elements: FDA provides many recommendations when using SUPERS to insure they are legible, understandable and in close proximity with the claim. In addition, if qualifying information is complex and requires more than one line of text, FDA recommends using other means to convey this information.
2. In addition to distracting visuals during the audio presentation of risks, the use of even inherently compelling, vivid visuals which may be deemed too inconsistent in tone or imagery that they distract the audience from listening to or processing the risks.
3. Audio Considerations such as speech quality, pacing, volume and background music need to be comparable during both benefit and risk presentations.

It's important for Pharma Marketers  to keep moving forward without feeling like their hands are tied...and to not let the guidance sap  creativity across communications and media platforms.

The Draft Guidance is open for comment for 90 days after publication in the Federal Register, which has not yet occurred.  This provides an opportunity for proactive leadership, especially if the industry wants to see more dialog around  web guidance.

For more information on a Conference Call and the Ad Hoc Coalition, see the Memorandum drafted by McDermott Will & Emery via Fabio Gratton at ignitehealth blog and eye on fda.

FDA Issues First-ever Draft Guidance on Pharma's Use of Social Media ....Were You Fooled?

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If you followed Twitter yesterday, you quickly learned that John Mack's Pharma Marketing Blog was indeed wishful thinking and an April Fools joke...

Today's post explains what was behind it...

"Now that everybody has calmed down about my April Fools joke (ie, "FDA Issues First-ever Draft Guidance on Pharma's Use of Social Media!"), we should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.

I suggested this in yesterday's post (see "FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!") because it seems that the FDA and some pharma companies are "mulling" this over behind closed doors and I want those doors opened. What do you think?"

On one hand, I certainly agree with John Mack's point that the door should be open for broader input than just a few pharma companies. On the other hand, if a few pharma companies are willing to step up and drive the process and thinking behind social media in pharma, I'm not so sure that's a bad thing as long as the guidance is issued as draft and circulated for public commentary (and the public input is taken seriously)

BTW....If you haven't listened to the 15 minute podcast that Mark Senak did with  Dr. Jean Ah Kang, special Assistant to Tom Abrams at DDDMAC in charge of Web 2.0 policy development, entitled "A Converstation with FDA/DDMAC About Pharma, Social Media and Web 2.0", you may want to.  While it's just the beginning of the dialog with pharma...Dr. Kang reinforces a few points, namely:

1.  DDMAC recognizes the growing importance of social media and that it is here to stay...Dr Kang also recognized that 3rd parties can come in and alter communications, so it's about the pharmaceutical company's involvement and  original intent...in other words, the pharma company is responsible for what they put into it...

2.  "It's not the medium, but the message."  Whether its social media or DTC TV, pharma companies must stay true to FDA regulations in terms of presenting their products with balanced risk/benefit information according to their approved label.

3 . Pharmaceutical companies are welcome to ask for advisory input to 'new' campaigns, including those that they will be running with web 2.0 media.

What do you think?

A Few Takeaways from the FDA Risk Communication Advisory Committee Meeting

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On February 26-27, the FDA Risk Advisory Committee met to review the following questions.  The offical docket slides.

I was able to participate in the meeting on Friday and present some thoughts with regard to "How Neuroscience Learning Might Help Improve Risk and Benefit Communications" (Thanks to some great work by Dr Medina and presentation support by Garr Reynolds of Presentation Zen) My talk suggested: 1) Greater use of multi-sensory communication elements beyond just words to include visuals,  2) Focus on what is most important--'less is more' -- as humans generally have difficulty digesting too many pieces of information at once 3) humans need repetition to learn--so if its truly important-- repeat, and lastly 4) patterns can aid learning so formats like the drug fact box can be very helpful.

I also enjoyed two of the morning presentations: 1) The Effectiveness of the drug facts box in communicating the benefits and side effects of prescription drugs (L Schwartz/S Woloshin Outcomes Group, VA Medial Center, White River Junction, VT.)  The drug fact box has received much attention recently and represents a vast improvement in design and communication of risks and benefits--and as you will see, made it into the advisory committee's final recommendations...and 2) Consumer Medicines Information in Europe; learning from research, policy and practice (Dr Raynor Prof of Pharmacy Practice, Univ of Leeds, UK) 

Catalina Health Resources also appealed to the committee to mandate one document of patient risk information at the pharmacy level. 

By the end of the two-day session, the advisory committee had unanimously agreed to 9 recommendations for the FDA. Please note that these recommendations were not handed out in writing so this represents my best summary of the committee's discussion and final agreements:

1. FDA should adopt a single standard document communicating the essential information (PPI, CMI, MG) through an appropriate consultative process from key stakeholders.
2. The standard document should include quantitative summary of risks and benefits, along with use and precautionary information. [However, there was discussion that any use of quantitative summary must be thoroughly tested to insure it communicates what is intended].
3. FDA should adopt the drug facts box as the standard format but engage in a process for the standardization of elaborating information supported by research.  This includes establishing a standard format for 2nd tier of elaborating information for those patients that want more...the full effects and unintended effects should be further tested and identified through a rigorous evaluation process, building on existing research and learning. There was recognition that all the information can't be in one document. Engage more research, building on what's the best format for communication; e.g. top ten lists? Q&A?
4. FDA should rely on the existing review process to derive the authoritative information that the standard document requires, including pharmaceutical company submissions and expert panel summaries. It should include process for including up to date post marketing information on all drugs.
5. FDA approved and required communications should be subject to rigorous empirical evaluation of their effectiveness (including usability but bigger).
6. FDA should establish performance standards for the patient and caregiver effectiveness that are outcomes based.
7. FDA should conduct a systems analysis of the dissemination process by which standard documents reach consumers at times relevant to their decision making about a product's adoption and use.
8. FDA should identify populations for which the standard document or dissemination system is inadequate. It should address their needs. (There were some very good discussions and videos of how different populations may need more thought with regard to dissemination and efffective communications e.g. homeless, illiterate, language barriers etc)
9. FDA should continue to strengthen its practice of relying on the best available social and behavioral science for designing and evaluating communications, including research on textual, numerical and visual displays. It should foster research relevant to improving the effectiveness and dissemination of its standard documents. It should include analytical research for identifying information most critical to decision making, tailoring material to relevant populations.

Overall, I was personally pleased to see that the advisory committee recommend to FDA: ONE document for the consumer at pharmacy level vs the many they now receive, adopting the drug fact box format to provide consumers with simpler and more effective risk/benefit communications, exploring greater use of quantitative textual information and visual displays to improve readability and comprehension (though not without iterative research to insure that patients take away what is intended). The committee seemed to embrace the notion that 'less is more' when it comes to 'effective' communications for consumers...(can it really be true?)

So this is the essence of what I took away. Any other thoughts or recommendations?