FDA Announces DTC, Fair Balance and the Internet Studies

The FDA is going to study the Internet.  In the Federal Register tomorrow, the agency is publishing a notice seeking comment on the “Examination of Online Direct-to-Consumer Prescription Drug Promotion“.

Here is an excerpt:

“Pharmaceutical products are launched and marketed in a number of new modalities and venues that did not exist a short time ago.  Increasingly, prescription products are promoted to consumers online in such formats as banner ads, Web sites, and videos.  The interactive nature of the Internet allows for features not possible with traditional media (i.e., print, radio, and television), such as scrolling information, pop up windows, linking to more information, and embedding videos.  FDA regulations require that prescription drug advertisements include a “fair balance” of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information (21 CFR 202.1(e)(5)(ii)).  All prescription drug ads that make claims about a product must, therefore, also include risk information in a “balanced” manner.  Currently, there are a number of questions surrounding how to achieve “fair balance” in online DTC promotion.”

Can it be that FDA and DDMAC are finally realizing that there is in fact a difference between the Internet and Social Media and traditional print and broadcast?

The fact that the agency is seeking such input is in and of itself, good news.  The fact that it is so many years after the advent of the Internet, of search engines and of social media is not.  And it is somewhat of a mystery because it seems that the topic would have been considered included in the deliberations of the November 2009 public meeting on the regulation of the internet and social media which were held to eventually – and now quite eventually – yield a draft regulation – now several months and two missed deadlines late.

The notice describes three concurrent studies that will be undertaken to assess the placement and presentation of risk information in the context of this “new” media environment to better assess how fair balance should be portrayed in various circumstances.

  • Study 1 will investigate and study format –  whether the presentation of risk information on branded drug Web sites influences consumers’ perceptions and understanding of the risks and benefits of the product;
  • Study 2 is to investigate how special features such as personal testimonial videos and interactive visuals on branded drug Web sites influence perceptions and understanding of the risks and benefits of the product; and
  • Study 3 is to investigate whether links to and citations from external organizations referenced on the homepage of branded drug Web sites influence consumer perceptions and understanding of the risks and benefits of the product.

We are nearly 15 years into the Internet and many years into patients turning to it as a primary resource for health information.  Research is good.  Timely research is even better, of course.  The public will have 60 days to provide comment on these studies.

One has to hope that the agency pegs down Web 2.0 before Web 3.0 is well underway….

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1 Response to FDA Announces DTC, Fair Balance and the Internet Studies

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