Pharma Trade Group Has New DTC Guidelines
6 CommentsBy Ed Silverman // December 10th, 2008 // 9:38 am
PhRMA has just issued its anticipated list of do’s and don’ts, which take effect this coming March. Keep in mind, folks, that these are voluntary guidelines. Drugmakers that agree must certify they will abide by the rules and the paperwork must be signed by the ceo and chief compliance officer. What’s the punishment for failing to get with the program? PhRMA issues a periodic report - a sort of ’shame on you’ approach. Time will tell if that works.
Among the items - discontinuing ads when new safety or risk info becomes known; including a toll-free number to the FDA Medwatch program; include info about lifestyle options; clearly list all benefit info, including warnings; avoid targeting inappropriate audiences, such as children, when applicable; acknowledge when actors are being used (this is the Bob Jarvik rule) and any compensation given healthcare professionals; verify celebrity endorsers actually believe what they are saying (that’s a good one); alert health care professionals about upcoming ad campaigns, and spend an “appropriate amount of time” educating docs about a new med or indication.
Here is the PhRMA statement and the guidelines.
Justice in MI
Many devils in many details. For example: “discontinuing ads when new safety or risk info becomes known.”
How will that be defined, I wonder. An actual label change that must have been approved by the FDA? And a change that meets the much higher bar of causality than the earlier CBE regulation?
Under the current regime, it is hard to imagine companies would be allowed to pull ads because of “new safety or risk info” by lesser critiera.
Justice in MI
OK, here is the answer, from the PhRMA guidelines:
“Working with the FDA, companies should continue to responsibly alter or
discontinue a DTC advertising campaign should new and reliable information
indicate a serious previously unknown safety risk.”
This is pretty much identical language to the new, and more restrictive, CBE regulations. So, in actuality, ads will be _less_ likely to include potentially important risk information than previously. (”Working with FDA,” “new and reliable,” and “previously unknown” are the relevant code phrases.)
atlex
JiM,
I may be missing your point, but why would the ads be less likely to include safety information than previously? All existing relevant safety information is expected to be addressed in ads already. This piece of the Code simply suggests that if new safety risks come to light, the DTC ad should be altered or pulled. This may not be the most powerful statement ever, but there seems to be nothing inherently wrong with codifying this practice.
Morris
Jim
How about altering the current format: Sunshine, person speaking clearly while smiling and telling the benefits, followed by clouds and mumbling, speaking the risks in a faster voice pace. I wonder if this has been considered.
atlex
Jim,
I believe that that’s what is being addressed in this piece of the code:
DTC television and print advertising should be designed to achieve a balanced
presentation of both the benefits and the risks associated with the advertised
prescription medicine. Specifically, risks and safety information, including the
substance of relevant boxed warnings, should be presented with reasonably
comparable prominence to the benefit information, in a clear, conspicuous and
neutral manner, and without distraction from the content.
Atlex
Justice in MI
Atlex - The crux is the parallel between PhRMA’s language and that of the new CBE regulations, which narrowed the circumstances in which, and the criteria by which, companies could and should initiate reporting new risk information. All this is in the service of reducing their potential accountability for _not_ doing so.
In effect, therefore, what PhRMA is advocating here, is that _narrower_ conception of a company’s responsibility. (Even though the language does not sound like that for folks not familiar with its referents.)