Well, it appears the FDA are on some sort of mission, 'appears' being the operative word here as they, like the MHRA, often talk the talk but rarely walk the walk.
The FDA announced earlier this week that they were cracking down on misleading or inaccurate promotion of prescription medications, apparently designed to educate health care professionals so that physicians and others can help the agency.
They have eyes don't they?
The FDA'S 'Bad Ad Program' have even designed a brochure for us all to download. My lack of faith in medicine regulators sees this as a 'cover ourselves in garlands' exercise.
I have to laugh at this, particularly as last year I highlighted on my blog that the UK regulator, the MHRA, had teamed up with pharma giant's Pfizer to launch a series of ad-campaigns throughout UK cinema's.
Here's their second ad
Pretty strong stuff, eh?
The message is quite clear. Don't buy your drugs off the Internet because they are probably fake. In other words, Pfizer's Viagra is losing sales due to people selling different versions of them online.
Of course, the MHRA would take a different stance, spouting that Internet sales of fake pharmaceutical products is a big problem. It probably is... but not half as big as the problem of consumers struggling with severe side-effects of the drugs they have popped that have been manufactured by the 'industry'.
The MHRA followed up with a poster and website campaign. Once again Pfizer were on board to help promote this campaign.
Here's one of the posters from their website, REALDANGER. Get Real, Get a Prescription™
I can't really claim that the above ad is misleading but it's just an example of the regulator working with the industry rather than with the patient.
Here's an ad that aired in the UK last year - remember, prescription medication is not allowed promotion on British TV.
I found the ad misleading:
"40% of men over 40 may have suffered some degree of erectile dysfunction," says the voiceover. This claim is then juxtaposed with a pop-up subtitle that states: "12 year study of US males. The Massachusetts Male Aging Study 1994."
Firstly, why is an ad airing on British TV using data that refers to American men and secondly, why are they using a study to back up their claim that is 15 years old?
The ad promotes the website 40over40.com, a website sponsored by Eli Lilly and Company.
I pondered complaining to the MHRA but it seems they have already received a complaint about this particular ad, a complaint that they did not uphold!
** Prohibition of advertisements for medicinal products on prescription only
7. Subject to regulation 11, no person shall issue an advertisement which is likely to lead to the use of a relevant medicinal product which is a medicinal product for supply by prescription only and which is subject to any of the restrictions imposed by section 58(2) of the Act.
Source: The Medicines (Advertising) Regulations 1994
So, if the FDA are really serious about misleading drug promotions, they, like the MHRA, need to get their own house in order first.
Here's a few ads the where the FDA previously buried their heads in the sand.
See if you can spot the deliberate flaws.
[Ad for Paxil 1999] [Back story]
Here's a Paxil ad from the year 2000
...more of the same from 2002
There are many more to view on youtube.com [Paxil Ad Search]
The FDA's new "Bad Ad Program" aims to ensure that promotional information is accurate, balances the risks and benefits of a product, is consistent with prescribing information approved by the FDA, and includes only information that is supported by strong evidence from clinical studies.
I'd write more about this but my concentration has just been broken by a pig flying past my window!
PAPERBACK COMING SOON.
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