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Day Two of the FDA's Risk Communications Advisory Committee was (at least in theory) to focus on Section 906 of FDAAA that requires the FDA to study and produce a report on whether or not an 800 number in DTC television ads would distract from risk information presented via current fair balance and adequate provision practices.
"In theory," because the meeting did address this issue -- but the majority of the time was spent discussing other things.
First up was supposed to be Kit Aikin to present the FDA's proposed study protocol -- but she was feeling under the weather and was replaced by the very capable (and very pregnant) Amy O'Donoghue.
Amy discussed the FDA's proposed research experiment (sampling, design, proposed stimuli, etc.) and the always fascinating Federal Paperwork Reduction Act. The latter because she needed to remind the committee about our fourth branch of government -- the Office of Management and Budget -- and how OMB regulations impact the general timing of the FDA rule-making process.
(When asked how long it could take to complete the rule making process, Kristin Davis of DDMAC commented, "You're looking at a couple of years." And this is after the 24 months the FDA has to complete the research study. One committee member was incensed and commented that Congress' intent was probably to delay the issue indefinitely and that something should be done about this OMB thing.)
BTW -- all the presentations, including the research protocol slides, can be found at www.regulations.gov. (reference docket FDA-2008-N-0226).
Some of the issues that came up:
* The use of the terms "adverse event" and "side effect" being used inter-changeably. Just what do consumers think they mean? The committee seemed to think that the FDA should look into this.
* How can poly-pharmacy patients report an adverse event when they can't be sure what's caused it?
* Will an 800 number (presented via a super, audio, or both) cause a "power of suggestion" situation, thus producing a kind of adverse event "placebo effect."
These general themes led the committee to worry (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility. A serious "signal-to-noise" issue. Of particular worry was how the FDA would then use this information relative to communicating "early safety signals." Talk about unintended consequences!
* Speaking of FDA's use of information, it came out that DDMAC isn't looking at MEDWATCH reporting data. Explantation: they don't have the staff time to do the extra work. Bad excuse. Seemed to me, based on the response of the agency folks present, that this isn't something DDMAC's ever even thought about.
* Per how to best present an 800 number, there was general committee consensus that it would require both a super as well as audio. The "super-only" concept was shot down by one panelist who commented that "people aren't going to have pens and paper at the ready to copy down a number."
(Note to pharma physician detailers -- maybe a new use for pens.)
One committee member even suggested a "CNN-like crawl" that might run continuously during TV ads. (So now we're going to make risk information less distracting by making DTC ads more distracting?)
* Much discussion as well on how a regularly communicated 800 number would advance "the FDA brand" -- by showing that the agency is taking the lead not only in drug safety, but in safe use of medicines. Committee Chair Fischhoff commented that "the better the FDA brand, the better the industry brand."
Amen.
The concept of an FDA public service announcement on reporting adverse events/side effects was discussed at great length -- as well as how the agency might pay for production and get media placement. And there were a lot of "creative" ideas about the PSA. At this point, lots of people in the audience began picking at their blackberries.
* Much time also spent discussing the need to educate the American public that all drugs have both risks as well as benefits.
Where have I heard that before?
Here's the brief Reuters report of Day Two:
www.reuters.com/article/healthNews/idUSN1641693720080516
My favorite comment came from a note handed to me during the meeting that said, "Hmm, a 1-800 number for ED ads? I thought those would be 1-900 lines and cost $3.99 a minute."
As always -- where some see a problem others see opportunity.
"In theory," because the meeting did address this issue -- but the majority of the time was spent discussing other things.
First up was supposed to be Kit Aikin to present the FDA's proposed study protocol -- but she was feeling under the weather and was replaced by the very capable (and very pregnant) Amy O'Donoghue.
Amy discussed the FDA's proposed research experiment (sampling, design, proposed stimuli, etc.) and the always fascinating Federal Paperwork Reduction Act. The latter because she needed to remind the committee about our fourth branch of government -- the Office of Management and Budget -- and how OMB regulations impact the general timing of the FDA rule-making process.
(When asked how long it could take to complete the rule making process, Kristin Davis of DDMAC commented, "You're looking at a couple of years." And this is after the 24 months the FDA has to complete the research study. One committee member was incensed and commented that Congress' intent was probably to delay the issue indefinitely and that something should be done about this OMB thing.)
BTW -- all the presentations, including the research protocol slides, can be found at www.regulations.gov. (reference docket FDA-2008-N-0226).
Some of the issues that came up:
* The use of the terms "adverse event" and "side effect" being used inter-changeably. Just what do consumers think they mean? The committee seemed to think that the FDA should look into this.
* How can poly-pharmacy patients report an adverse event when they can't be sure what's caused it?
* Will an 800 number (presented via a super, audio, or both) cause a "power of suggestion" situation, thus producing a kind of adverse event "placebo effect."
These general themes led the committee to worry (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility. A serious "signal-to-noise" issue. Of particular worry was how the FDA would then use this information relative to communicating "early safety signals." Talk about unintended consequences!
* Speaking of FDA's use of information, it came out that DDMAC isn't looking at MEDWATCH reporting data. Explantation: they don't have the staff time to do the extra work. Bad excuse. Seemed to me, based on the response of the agency folks present, that this isn't something DDMAC's ever even thought about.
* Per how to best present an 800 number, there was general committee consensus that it would require both a super as well as audio. The "super-only" concept was shot down by one panelist who commented that "people aren't going to have pens and paper at the ready to copy down a number."
(Note to pharma physician detailers -- maybe a new use for pens.)
One committee member even suggested a "CNN-like crawl" that might run continuously during TV ads. (So now we're going to make risk information less distracting by making DTC ads more distracting?)
* Much discussion as well on how a regularly communicated 800 number would advance "the FDA brand" -- by showing that the agency is taking the lead not only in drug safety, but in safe use of medicines. Committee Chair Fischhoff commented that "the better the FDA brand, the better the industry brand."
Amen.
The concept of an FDA public service announcement on reporting adverse events/side effects was discussed at great length -- as well as how the agency might pay for production and get media placement. And there were a lot of "creative" ideas about the PSA. At this point, lots of people in the audience began picking at their blackberries.
* Much time also spent discussing the need to educate the American public that all drugs have both risks as well as benefits.
Where have I heard that before?
Here's the brief Reuters report of Day Two:
www.reuters.com/article/healthNews/idUSN1641693720080516
My favorite comment came from a note handed to me during the meeting that said, "Hmm, a 1-800 number for ED ads? I thought those would be 1-900 lines and cost $3.99 a minute."
As always -- where some see a problem others see opportunity.
Speaking of DTC, here's what I had to share with Mike Schneider on Bloomberg TV:
vimeo.com/1020779
Speaking to an FDA advisory committee is one thing, speaking to the American public --the ultimate advisory committee -- is something else entirely.
(And the latter is more intimidating.)
vimeo.com/1020779
Speaking to an FDA advisory committee is one thing, speaking to the American public --the ultimate advisory committee -- is something else entirely.
(And the latter is more intimidating.)
The second half of Day One was all about what the FDA is doing to help spread the message of safety/efficacy -- with a particular focus on the issue of "safe use" of drugs.
Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).
They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate.
But what does any of this have to do with DTC and under-served communities?
Let's just say it's tangential.
But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.
Danger, Will Robinson, danger.
Day One closed with "Committee Discussion." Some nutty. Some really useful.
Some examples:
* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.
* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea.
* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.
Yes, industry.
A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.
* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements."
At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.
Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.
Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).
They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate.
But what does any of this have to do with DTC and under-served communities?
Let's just say it's tangential.
But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.
Danger, Will Robinson, danger.
Day One closed with "Committee Discussion." Some nutty. Some really useful.
Some examples:
* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.
* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea.
* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.
Yes, industry.
A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.
* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements."
At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.
Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.
To spice up my testimony, I enlisted help from Samuel Johnson, Juvenal, Woody Allen , and W. Edwards Deming.
In closing, I urged the committee to ponder this question posed by T.S. Eliot:
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?
Is anybody listening?
In closing, I urged the committee to ponder this question posed by T.S. Eliot:
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?
Is anybody listening?
Andreas Lord, of Eastern Research Group, presented a lit search of studies done relative to DTC issues and the "under-served" populations discussed in FDAAA.
Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."
The recommendations of the committee -- more research.
Very helpful.
This hearing is beginning to be like treading water in treacle.
Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."
The recommendations of the committee -- more research.
Very helpful.
This hearing is beginning to be like treading water in treacle.
Only two people offered public comment. One was a woman talking about advertising for atypical antipsychotics. The other was me. The buzz among the press corps was "where's pharma?"
Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."
I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.
Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."
I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.
Very pleased to announce the launch of "The Patient," the new benchmark journal for peer-reviewed authoritative and practical articles on the application of pharmacoeconomics and quality-of-life assessment to optimum drug therapy and health outcomes.
According to the publisher (Wolters Kluwer Health), The Patient is "an invaluable source of applied pharmacoeconomic original research and educational material for the healthcare decision maker. The journal is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization."
Here's a link to the magazine's website
John Bridges (Johns Hopkins School of Public Health and Senior Fellow, Center for Medicine in the Public Interest) is the journal's lead editor.
(And, in the interest of full disclosure, I am on the editorial board.)
Here is a link to the magazine's website: http://thepatient.adisonline.com
We welcome this important new voice to the debate.
Raising premiums and squeezing providers...that will just put HMOs on the political hot seat again. Ultimately the health care decisions and dollars will have to flow doctors and patients and the real solution will be found in technologies based on underlying mechanisms of disease..
washingtontimes.com/apps/pbcs.dll/article
washingtontimes.com/apps/pbcs.dll/article
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