Monday, April 28, 2008

What's Behind AstraZeneca's New Push for FDA Preview of DTC Ads?

Reuters reports that AstraZeneca (AZ) is "urging U.S. lawmakers to revive a program for drugmakers who want to voluntarily submit their television commercials for regulatory review" (see "AstraZeneca pushes for reviews of TV drug ads").

AZ suggested that funding for this program should come pharma companies or, since there has been lawmaker opposition to this (see "FDA Won't be Previewing TV DTC Ads!"), from taxpayers like you and me.

Why is AZ so keen on this idea?

Some have suggested that it is merely a PR ploy, which had its genesis way back in November, 2005 when I first reported on AZ's proposal. Back then I noted that AstraZeneca stunned attendees at an FDA public hearing on DTC with an announcement proposing "a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer (DTC) advertising to the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing and Communication (DDMAC) for review prior to its use" (See "AstraZeneca's Risky Proposition").

At that time, a Pharma Marketing Roundtable member commented: "Knowing that the FDA is woefully understaffed for this type of effort, it's a 'can't lose' offer on Astra Zeneca's part! However, it'’ll play well in the popular press so my sense is that it was a smart move on their part."

But writing letters to lawmakers is not so visible to the public as to be an effective PR ploy. There must be another reason why AZ is so keen on this idea.

I think that AZ and other drug companies want the FDA to pre-approve TV ads because there are several advantages that the industry will gain, including the "loophole" that pre-approved ads can very rarely be recalled after the fact. That will drastically cut the number of warning letters the FDA issues to drug makers. Although these letters are mere slaps on the wrist and are ineffective -- ie, akin to closing the barn door after the cow has left -- they are bad publicity.

IMHO, AZ's call for FDA preview of DTC is designed more to prevent BAD publicity, than to create GOOD publicity.

Also, if the money comes from the industry rather than the public, the industry will have even more control over the FDA than it currently has (see "Pay-(FDA)-Per-(Pre)View of DTC"). On the other hand, if FDA gets taxpayer money for this, the drug industry can save some money and still reap the benefits.

BTW, don't expect FDA pre-view of TV DTC ads to actually IMPROVE these ads. Many of them will still be silly, creative fluff like the Lincoln-Beaver Rozerem ads that have won so many awards (see "Rozerem Ads Dis Lincoln, Show Beaver").

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  1. Anonymous8:41 AM

    it is a condom against tort suits.

  2. Mario Cavallini11:48 AM

    Actually, it's protection against FDA penalties.

    Once upon a time, FDA warnings were slaps on the wrist, because they had the choice of either wagging a finger or going nuclear (revoking approval to market for a drug).

    However, last year's FDAAA gave FDA authority to impose fines for marketing violations. Now, FDA can impose penalties to match the violation.

    By seeking pre-launch approval of TV ads, AZ (and Pharma) want cover. If DDMAC reviews an ad and finds no problems, but later on comes up with an objection, Pharma wants the ability to come back with the legal equivalent of, "But Mom, you said OK!"

  3. Good point, Mario. I believe the penalty could be MUCH greater than the user fee for previewing ($250,000 penalty per day vs. $41,000 to preview). Therefore, it would certainly be good "insurance" to add the user-fee back to the current law, which is all pain, no gain right now.

  4. AstraZeneca though intensionally a very good Pharma marketer. With strong presence worldwide. However during my association with the company in India, I have found it more sale aggressive and violating some norms and code of pharma marketing. As there is a saying " do as romans do in rome" similarly it has also been playing dirty game in India. Is the impact of india being used in US too i.e inducing authorities make follow and support as per the wish of company which is not favour of the consumer.

  5. Anonymous4:57 PM

    Your Television as you doctor?

    Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state and the commercial is sponsored usually by a big pharmaceutical company for a particular network.

    This is called direct to consumer advertising, and doctors would prefer they did not exist.

    Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns. And involves money spent that could be applied to greater uses, according t many, but we are dealing with a corporation here.

    The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective, which is to increase sales and grow their market and, in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition. Furthermore, the FDA has admitted that they are ignorant as far as the content of such DTC ads, in relation to their accuracy and clarity, as well as their effect on the health care system.
    DTC advertising is also a catalyst for and similar to disease mongering.

    Disease mongering is the creation of what some believe to be medical flaws, and illustrated by the creators through exaggeration and embellishments through media sources as an avenue for suc propaganda, as is often seen with DTC advertising. Yet the flaws may not be medical, but corporate creations of these questionable human ailments that do not require treatment, possibly, and may be an attempt to develop a particular medical condition to acquire profit. One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.

    Also, DTC ads discuss only one treatment option normally, so it seems, when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the doctor, as they assess your health, not your television or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of our country and New Zealand.

    Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome for the doctor chosen for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription.
    Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some over-prescribing, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which is far from financial prosperity.

    “Men of ill judgment oft ignore the good that lies within their hands till they have lost it”


    Dan Abshear


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