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Wednesday, January 07, 2015

FDA's 2015 Guidance Agenda - Just Like the 2014 Agenda - Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites

FDA/CDER has published its 2015 Guidance Agenda (here). Here's what's under the Advertising Category:
  • Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
  • Direct-to-Consumer Television Advertisements – DTC Television Ad Pre-Dissemination Review Program for Human Drugs
  • Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
  • Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
  • Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
  • Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Some of these guidances -- such as the DTC Television Ad Pre-Dissemination Review Program guidance -- have already been released as draft documents (see, for example, this review). I suppose the FDA is planning on publishing "final" guidance documents based on comments to the draft documents. Or maybe just "revised" draft documents.

I highlighted one item on the list having to do with "Internet/Social Media Advertising" -- Use of Links to Third-Party Sites. This was also on FDA's 2014 Guidance Calendar, but as we know no guidance was issued in 2014.

Perhaps none will be issued in 2015 either. Why not?

Links were discussed by several presenters at the November 2009 public hearing. I also surveyed Pharma Marketing News/Blog readers to get their opinions. The survey was closed on February 26, 2010 after collecting responses from 274 people. A summary of the results -- including 731 comments -- was submitted to the FDA. You can download the results here (pdf).

When asked "When is the use of links appropriate? Should parameters be established for links to and from Web sites?," 55% of 181 survey respondents said "Yes" whereas only 24% said "No" (see chart):

PHARMA=pharma industry respondents, AGENT=pharma ad/marketing agency respondents
The comments were more interesting:
Probably, but good luck drafting them.

Not practical to police this. it is a hyperlinked world.

If a sponsor is going to itself enable or allow a link to another site where information about that sponsors product is known to be posted and or discussed then the sponsor is responsible for monitoring the information from an accuracy, appriateness (sic) and legal point of view using best "commercially reasonable" efforts. If information is posted that is incorrect, inapropriate or illegal then it is the sponsors responsibility to take all necessary steps to correct, change, eliminate or comment about the offending information to the site owners where the information is posted.

A simple notice that the user is being redirected to a new site should suffice. Most audiences are sophisticated these days to know how these campaigns work and if they don't want to continue on to read about a treatment they don't have to.

blogs are often used to draw traffic to a website to restrict this handcuffs companies and also robs the public from accessing the support documents for the view they are reading. Even FDA has links.

Linking of off-label information from an unbranded site is clearly a no-no. I am surprised companies would even try that trick.
As I did in 2014, I anxiously await FDA's 3rd and final Internet/SM guidance document it originally promised for 2014 and hope it addresses the above comments.

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