Regulatory Considerations in Optimizing a Site for Mobile

  • Fact: One of the primary uses of the Internet is to seek health information.
  • Fact: By 2015, nearly two-thirds of Americans now have a smart phone;
  • Fact: Of those owning a smart phone, 62 percent have used their phone in the past year to look up information related to a specific health condition
  • Fact: For a significant number of those Americans who own smart phones (10 percent), it is their sole means of accessing the Internet and 15 percent say that they have limited means to access the Internet beyond their smart phone data plan and those dependent on smart phones for Internet access tend to be young, lower income and non-white (Source:  Smartphone Use in 2015 – Pew Internet & American Life Project, April 1, 2015) ;
  • Fact: Many health sites, and drug-related Websites are not optimized for mobile;
  • Fact: FDA needs to provide solid guidance on how to optimize a site for mobile within regulatory parameters.

FDA is not alone in failing to grasp the scope of change that has occurred in communications in the past 10 years. In 2009 when the agency held its public meeting on the regulation of the Internet and social media related to pharmaceutical products, the smart phone as we know it was nascent. By 2011, 35 percent of Americans owned one and today it is not only fairly ubiquitous, it is the primary means for some to access the Internet and seek health information. There is catching up to do.

One of the many holes left in the guidance documents that were finally forthcoming from the agency as a result of that 2009 meeting is with respect to the optimization of web site for mobile. FDA has steadfastly stood by its 20th century paradigm for 21st century technologies that where a drug name and indication occur there must also be risk information. Use of links to incorporate risk information has been deemed clearly unacceptable since the 2009. What does that mean for pharmaceutical companies that need to mobilize brand name sites for use by mobile Internet users?

To find out what was going I visited 10 different drug sites representing a span of therapeutic categories and manufacturers to see how industry was working this issue and found a variance in approach.

  • Of the 10 brand-name web sites, 5 either did not exist as stand alone sites or were not optimized for mobile at all, meaning there was no website that was accessible by smartphone that would available to seekers of such information – clearly not in anyone’s interest;
  • 2 of the optimized sites had landing pages that had the name of the drug, but did directly not name the indication. Some had links that went to non-optimized information;
  • Some of the landing sites had the indication information with the beginning of risk information, but one had to scroll down to continue reading it or there was an very brief indication followed by safety/risk information, which was continued below, with links to other resources.
One could consider that the tortured guidance document from FDA on Internet/Social Media Sites with Character Space Limitations might be of some help. While widely considered to address Twitter as a platform, FDA did not seek to make its guidance platform specific. There may a structure or insights – one could lay out a sort of mobilized landing page based on the parameters of what must be included in the fictional tweet example that FDA provided, but it is not clear.

In short, the lack of guidance has led to a hodge-podge approach for brand name drug sites to optimized for mobile. Where there is not optimization, users must navigate small test to find brand information on a non-optimized company site or non-optimized brand site which is not an ideal circumstance to say the least. While most can resort to seeking the information on full screen, many will not have access and those who are being disadvantaged would appear to be the young, poor and non-white.

The changes that have occurred in communications have had a profound effect that has been underestimated by many, including FDA, but it is time for the agency to come up with a 21st century approach not only to changes in communications, but in the slow and laborious way that such communications are regulated.

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