Healthcare Matters

About 50% of the US patient population currently uses the Internet to conduct information searches on various prescribed drugs –and that number is obviously growing. Despite that fact, the FDA has been slow to respond to repeated Pharma industry requests for formal regulations covering the use of the Internet and social networking media.  Actually, “slow to respond” is an understatement. It’s been 15 years since the topic was initially raised for formal regulatory consideration, yet the FDA is still “considering.”

Is the FDA’s inaction intentional and/or evidence of its desire to maintain what appears to be a policy of ad hoc enforcement?  Or is it simply a function of an online application environment that moves too quickly for it to develop a reasonable regulatory approach?  Of course, the answers are all “yes,” but its passive/aggressive approach to enforcement has lost its charm.

The social media challenges faced by the pharmaceuticals are easy to understand, yet head scratchers to reasonably solve. For example, how do you communicate elaborate drug disclaimers or adverse events in a online banner? And how do you ensure that balanced information is returned in a search summary when the allotted text space isn’t adequate in size to communicate the “fair balance” demanded by the FDA.  FYI, the FDA defines “Fair Balance” as saying the “content and presentation of a drug’s most important risks must be reasonably similar to the content and presentation of its benefits.”

But the real watershed moment of this debate occurred when Facebook decided to enforce its policy allowing users to comment and share information with each other. Believe it or not, it was the pharmaceutical companies who sought to disable the Facebook comment feature because it knew the problem the FDA would have.  Why was that Facebook decision problematic for the pharmaceuticals?  Because a user might post a comment reflecting the benefit of a drug based on a personal experience (e.g. “that drug saved my father’s life”) and the FDA would consider such commentary as “promotional” (i.e. “unbalanced”) when presented on a company sponsored website. At any rate, that Facebook decision did some real damage; it caused most pharmaceuticals to take down their Facebook sites. Some sites have remained, but given the lingering risks, no one understands why.

There are three ways this is going to get solved:

• The industry creates a comprehensive guidance document and the FDA uses it;
• A “gold standard” representing FDA approved information is created. When users see the FDA seal of approval, they’ll know the information complies with the FDA’s definition of fair balance;
• The industry bypasses the FDA and goes straight to Congress.

While the FDA has backed off holding the pharmaceuticals liable for user comments that appear on their web site (that are considered promotional) and information downloads that get shared (posted, tweeted), nothing much has changed. Most of the concerns still being expressed surround the viral flow of anecdotal patient information in comment boxes and chat rooms.  And of course, this is where the rest of us say we derive most of the value, as this is where the Internet shines as a unique information source. Ironically, the FDA monitors unaffiliated social media and uses independent sites like these (www.adverseevents.com), as they have proven themselves to be effective at uncovering potential trends and problems –sometimes faster than the FDA. Regardless, as long as the legal risk outweighs the marketing benefit, you’re not going to see the pharmaceuticals step up and use social media to full advantage. And why we assume “to full advantage” implies risk and disadvantage to the consumer is simply “tired thinking.”

The FDA seems stuck trying to control an information flow that is inherently unstoppable. It’s time for the FDA to meet with the industry and make some realistic decisions.

–Tom Finn