Pharma: Seven Tips To Improve Your Next FDA Advisory Presentation

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) Continue reading

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

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.  Continue reading

Pharma: Twas the Night before #FDASM

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.

Continue reading

Are Pharma’s Hands Tied with New FDA Draft Guidance for DTC?

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! Continue reading

A Few Takeaways from the FDA Risk Communication Advisory Committee Meeting

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.  Continue reading