Tech & The District » pharmaceuticals Tech the way we see it: insights and musings on technology PR, policy and the District, from H&K’s D.C. Tech Team. Thu, 04 Aug 2011 15:06:44 +0000 en hourly 1 Promoting FDA–Regulated Medical Products Using the Internet and Social Media Thu, 03 Dec 2009 15:44:26 +0000 Vanessa Truskey A guest post by Steven Immergut, Senior Vice President & Director, Health Information Technology for H&K

A couple of weeks ago the FDA convened a much-anticipated Part 15 Public Hearing on the promotion of drugs and devices over the Internet and via social media.  The last time the Agency met on this topic was 1996. Over the course of two jam-packed days, representatives from advertising & PR agencies, consumer groups, health-related Websites, pharmaceutical companies, trade associations and Internet search engines gave more than 70 presentations of 15 minutes each. With the overwhelming majority of speakers coming from the private sector, the lack of patient and professional groups participating was notable (and pointed out by Diana Zuckerman, president of the National Research Center for Women & Families). PhRMA and AdvaMed presented their takes, as did a small handful of pharma companies (Eli Lilly, Sanofi-Aventis, J&J and Pfizer).

FDA positioned the Hearing as the beginning of a thorough process that will help them arrive at guidelines for industry.  Loads of data were presented about the Internet and social media use for health information. Not much was surprising, though the numbers are indeed staggering.  And there was a good deal of discussion about the need and challenge to regulate content, including adverse event reporting and balancing risk/benefit information.  Following are a few of the major themes that emerged:

  • Health information on the Internet continues to explode – and more so now than ever with booming social media utilization. The difference now from years past seems to be a universal consensus to embrace it and make efforts toward transparency and quality of information.
  • There’s agreement on the need for a filtering system to distinguish sources that are reliable from those that are not credible, or even irresponsible.
  • Historically, lack of clear regulatory guidance has stymied real engagement from the pharmaceutical industry when it comes to discussion of products on the Web. The hot-button is how to handle commentary on third-party sites and what is an acceptable level of accountability for both industry and regulators?
  • Active health information consumers actually want the industry to engage more online — only 1 out of 5 is opposed, according to McCann Health.
  • Because of the uniqueness of the medium, requirements for “fair balance” between benefit and risk should be modified for the Web, particularly for space-limiting applications like search results, microblogs, etc. The defining of reasonable and realistic will be major issues for debate on the go forward.
  • When it comes to social media, FDA guidelines on promotion by industry must ensure absolute transparency, must preserve social media norms and must be flexible for change over time.
  • Things to watch out for include the use of FDA logos to validate content, FDA-sanctioned links for adverse event reporting, and enhanced the user-friendliness of the current MedWatch program (not to mention campaigns to increase its awareness and usage in among professionals and consumers).
  • Finally, the discussion will eventually come down to resources. How will FDA secure the kind of resources necessary to do its monitoring and reviewing? Will pharma dedicate the resources necessary to effectively comply with the coming guidance?

Internet traffic among patients/caregivers and physicians is increasing so rapidly that the data crunchers indicated they have a hard time keeping up. A couple of data points that did stand out were:

  • There were 4.6 billion keyword searches (111 million being unique searches) on health terms during the last 3 months of 2007 (numbers from Google).
  • 75% of physicians are online daily (according to WebMD and others) and 60% have smart phones.

The tone on Day 1 was set with PhRMA presenting its written testimony, which proposes that the FDA approve a standard universal warning: “All drugs have risks.  Click here for more information from the manufacturer” – for use “in places throughout the Web where there is not enough room for complete disclosure of all warnings, indications, and contraindications.”  Such a warning would, PhRMA contends, allow companies to take advantage of sponsored links, make full use of Twitter, etc. as promotion vehicles, while also providing easy access to safety information.  PhRMA suggests that the warning incorporate the FDA’s logo, arguing that this could mitigate against “the dangers posed by illegal Internet drug sellers.”

Among the other interesting issues FDA may address is companies’ responsibility for Web content they do not control.  For example, Google’s introduction of Sidewiki, which allows anyone visiting a pharmaceutical company’s website to leave a comment, has brought this issue to the forefront, raising, for example, the prospect of doctors discussing a product’s off-label uses on the manufacturer’s site. If you haven’t seen Sidewiki yet, you can download it easily here:

There was universal agreement on the need for some kind of regulation on branded advertising but just what that compliance should look like is up for discussion.  Yahoo suggested display advertising that features scrolling safety info, available in its entirety via a click through (which by some definitions is technically two-clicks away).  Google offered up samples of search ads using non-branded, branded and even suggested standardization language for black-box search sponsored ads. News came out this week that Bayer’s Yaz is piloting a paid search format similar to that proposed by Google for products carrying black-box warnings.

While many of the speakers supported PhRMA’s concept for an ‘FDA seal of approval’ for Web sites, an FDA panelist asked, “How do we decide who gets it and what process do we go through?” That’s a point up for discussion, everyone agreed. The FDA also got suggestions to venture further in social media as an agency, prompting one panelist to note that the “FDA is on Facebook.”  The speaker replied, “Yes, but no one can FRIEND you!”

Several data presentations demonstrated that user-generated content does affect treatment decisions. But there’s “bad” user-generated content out there, and some responsibility still lies with the user – both consumers and health professionals. There will be ongoing debate on what to do about such content if pharma has no editorial control over the site. The common answer is that industry should not be responsible for it if they don’t control it. It will be interesting to see where the future guidelines net out regarding third-party sites that pharma companies sponsor. For some of these sites, companies provide content but don’t necessarily have day-to-day ownership. 

Day 2 centered on potential directions regarding adverse event and safety information. Here are a few of the ideas discussed:

  • Prohibit Pharma from promotion on anything other than product Web sites.
  • Radical simplification – lots of words isn’t necessarily better.
  • Flexibility on due diligence, including reasonable timeframes for reporting.
  • Monitoring of all mentions (apparently this IS possible – but is also debated).
  • Establish an FDA Task Force and Director of Social Media.
  • Allow pharma to post to Wikipedia (many are not allowed now) and include a link to official site and MedWatch.
  • Establish an “RxRisk” icon linked to a standard site ( and couple it with a massive education campaign.

The whole meeting came to a close with a presentation by Pfizer’s Senior Vice President & Chief Medical Officer, Dr. Freda Lewis-Hall and her colleague from Worldwide Market Analytics. They cited research on preferences and behaviors around different treatments of safety info on branded sites. Three conclusions: (1) There is interest; people want the information; (2)They want it in simple presentation and a familiar flow; (3) It’s a personal experience – not everyone navigates the same way. PFE will be doing a larger follow up study of some 6,400 patients suffering from high cholesterol and arthritis. They also cited physician data generated via its relationship with Sermo, or “the online doctors lounge.”  This research revealed that doctors are not interested in canned content; they want real-time interactions with medical/science people who can answer their questions in an unbiased manner. And they want to share this info via peer to peer exchange – 24/7 and real time. Ultimately, they want to be in control.

Timing on new guidelines is a bit of a wild card but the general consensus seems to be it won’t be until the first half of 2011 before we see something finalized. The archived Webcast is still available online for viewing and anyone who wishes to comment on the presentations or other internet-specific promotion issues may do so through February 28, 2010.

(Hill & Knowlton works with Johnson & Johnson and Pfizer in the U.S.)

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