Comments on: DTCA: Beneficial or Harmful? http://blog.pharmtech.com/2009/11/13/dtca-beneficial-or-harmful/ The blog of Pharmaceutical Technology magazine Tue, 07 Feb 2012 17:25:13 -0500 http://wordpress.org/?v=2.8.4 hourly 1 By: Carl Anderson http://blog.pharmtech.com/2009/11/13/dtca-beneficial-or-harmful/comment-page-1/#comment-23472 Carl Anderson Wed, 18 Nov 2009 15:09:02 +0000 http://blog.pharmtech.com/?p=2140#comment-23472 I agree with the American Journal of Public Health. DTC ads are very misleading and not helpful to most consumers. A multi-colored cartoon butterfly for a sleeping pill? The first amendment argument made above really doesn't apply to regulated health products. FDA should have the right to enforce strict standards for DTC ads. In the 1940s the Food, Drug and Cosmetic Act was challenged before the Supreme Court for violating the Constitution regarding facility inspections. The Court ruled that because of the nature of the industry that FDA should be given limited powers to conduct inspections, within the parameters of the Form FDA 482, Notice of Inspection. The same should apply to DTC ads. I agree with the American Journal of Public Health. DTC ads are very misleading and not helpful to most consumers. A multi-colored cartoon butterfly for a sleeping pill? The first amendment argument made above really doesn’t apply to regulated health products. FDA should have the right to enforce strict standards for DTC ads. In the 1940s the Food, Drug and Cosmetic Act was challenged before the Supreme Court for violating the Constitution regarding facility inspections. The Court ruled that because of the nature of the industry that FDA should be given limited powers to conduct inspections, within the parameters of the Form FDA 482, Notice of Inspection. The same should apply to DTC ads.

]]> By: cliffintokyo http://blog.pharmtech.com/2009/11/13/dtca-beneficial-or-harmful/comment-page-1/#comment-23393 cliffintokyo Wed, 18 Nov 2009 00:08:37 +0000 http://blog.pharmtech.com/?p=2140#comment-23393 S P: You made your point well; a DTCA lasting 30 secs is an advertisement, neither more nor less than. Let's start by posting patient information leaflets (PILs, required by law in the EU, and needing approval by the authorities) on company websites and see where that gets us with legislators. Perhaps authorities (FDA, EMEA, etc) could require companies to have, on their official website, a list of all drugs they sell prominently displayed with one click links to their PILs, as a consumer service. The next step might be a quick reference version of the PIL, containing only essential information, for time-challenged and lazy people..... S P:
You made your point well; a DTCA lasting 30 secs is an advertisement, neither more nor less than.
Let’s start by posting patient information leaflets (PILs, required by law in the EU, and needing approval by the authorities) on company websites and see where that gets us with legislators.
Perhaps authorities (FDA, EMEA, etc) could require companies to have, on their official website, a list of all drugs they sell prominently displayed with one click links to their PILs, as a consumer service.
The next step might be a quick reference version of the PIL, containing only essential information, for time-challenged and lazy people…..

]]> By: Saint Paul http://blog.pharmtech.com/2009/11/13/dtca-beneficial-or-harmful/comment-page-1/#comment-23373 Saint Paul Tue, 17 Nov 2009 19:41:04 +0000 http://blog.pharmtech.com/?p=2140#comment-23373 How do you say everything in 30 seconds? It's not possible. Patients can go to the website to learn more or talk to their doctor. The system works. Furthermore, Frosch's suggestions may chill free speech by violating the First Amendment: "Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances." How do you say everything in 30 seconds? It’s not possible. Patients can go to the website to learn more or talk to their doctor. The system works. Furthermore, Frosch’s suggestions may chill free speech by violating the First Amendment:

“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”

]]> By: cliffintokyo http://blog.pharmtech.com/2009/11/13/dtca-beneficial-or-harmful/comment-page-1/#comment-23288 cliffintokyo Tue, 17 Nov 2009 00:29:01 +0000 http://blog.pharmtech.com/?p=2140#comment-23288 The UK MHRA has just completed its survey regarding the proposed EU changes to allow companies to provide factual, non-promotional information about their products to consumers using media other than TV and radio, with DTCA still completely prohibited. The survey concludes that a large majority of stakeholders are in favor of a self-regulated system, (overseen by regulators with enforcement powers), for companies to provide such information. The MHRA is also cautiously in favor, with certain caveats regarding the burdens on regulatory authorities. This EU proposal probably represents the maximum allowable direct influence on consumers that companies could possibly be permitted to have without creating a large amount of regulatory and enforcement work e.g. to monitor internet sites and paper publications. Personally speaking, I imagine that a simplified version of the key information and instructions in the PIL for a prescription medicine would probably be welcome to most consumers. And beneficial, because I guess that most patients STILL do not bother to read the instructions. I definitely do not want the marketing dept version (take our drug and get better!). I would expect my specialist physician to be both familiar with the contents of the EPAR (Labeling in the US) and knowledgeable about experience in practice. However, if I had a serious condition, I would want to read the EPARs for the candidate drugs myself, especially as they are readily available on the European Medicines Agency website. The FDA labeling and medwatch alerts campaigns and numerous incidents during recent years have taught both insiders and outsiders to be very wary about side effects. The UK MHRA has just completed its survey regarding the proposed EU changes to allow companies to provide factual, non-promotional information about their products to consumers using media other than TV and radio, with DTCA still completely prohibited.
The survey concludes that a large majority of stakeholders are in favor of a self-regulated system, (overseen by regulators with enforcement powers), for companies to provide such information.
The MHRA is also cautiously in favor, with certain caveats regarding the burdens on regulatory authorities.
This EU proposal probably represents the maximum allowable direct influence on consumers that companies could possibly be permitted to have without creating a large amount of regulatory and enforcement work e.g. to monitor internet sites and paper publications.
Personally speaking, I imagine that a simplified version of the key information and instructions in the PIL for a prescription medicine would probably be welcome to most consumers. And beneficial, because I guess that most patients STILL do not bother to read the instructions. I definitely do not want the marketing dept version (take our drug and get better!). I would expect my specialist physician to be both familiar with the contents of the EPAR (Labeling in the US) and knowledgeable about experience in practice.
However, if I had a serious condition, I would want to read the EPARs for the candidate drugs myself, especially as they are readily available on the European Medicines Agency website. The FDA labeling and medwatch alerts campaigns and numerous incidents during recent years have taught both insiders and outsiders to be very wary about side effects.

]]> By: Chuck http://blog.pharmtech.com/2009/11/13/dtca-beneficial-or-harmful/comment-page-1/#comment-23218 Chuck Mon, 16 Nov 2009 14:20:08 +0000 http://blog.pharmtech.com/?p=2140#comment-23218 DTCA... Without appropriate understanding and context, harmful is likely. Stick to the facts, defer to the Doctors and drop the sensationalism! DTCA… Without appropriate understanding and context, harmful is likely. Stick to the facts, defer to the Doctors and drop the sensationalism!

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