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.
