Yesterday, we began recapping the public hearing held by the FDA to discuss the Internet and Social Media tools.  We focused on accountability, corrective information, and regulatory compliance.  Today we’ll recap linking strategy and adverse event reporting as well as discussing implications.

Linking Strategy: Several speakers discussed the importance of links, and that internet users today understand that while all the information may not be immediately in front of them, that it is accessible via links and clicking.  Several speakers spoke in support the one-click rule, that having full prescribing and safety information accessible through one click (from a banner or search link) is the equivalent of having product information on the back of a print ad.  Currently, the FDA has issued guidance that this approach is unacceptable.

Adverse Event Reporting: This one topic had most of the second day devoted to it.  Current, AE reporting is a complex topic, with a lot of important considerations.  Several speakers talked to the scope of what a pharmaceutical manufacturer is responsible for.  Given the breadth of the internet, it is impossible for an individual manufacturer to police everywhere for AEs. While current industry guidelines state that manufactures only need to actively monitor their own website, they also require manufacturers to report any AEs they do become aware of.  A few speakers asked for clarification of the definition of ownership, and sponsorship (as in advertising), and whether advertising on a site makes manufacturers responsible for AE reporting on that site.

Another major challenge around AE reporting is what qualifies as a reportable event.  According to the FDA, a reportable event has the following elements: patient, reporter, event and drug.  Nielsen Online states that only 1 out of 500 online AEs are reportable.  Speakers seemed to be split between respecting privacy rights of users vs. doing everything in their power to track down the rest of the required information to report the AE.

To help get around this issue, a few speakers suggested ideas such as developing iconography on brand-owned sites that link to the FDA-run MedWatch AE reporting website, or creating consistent AE widgets to be used by brands to create a safe reporting space for consumers.

Going forward

Unlike other hearings, the FDA did not make any immediate recommendations.  Rather, the FDA will continue to accept testimony through February of 2010.  At that point, it will begin consideration of any rules or guidance it will offer.  Several speakers suggested the FDA set up committees with members from the industry, consumer advocates, agencies and medical professionals to speed the process of developing guidelines.  Even so, some attendees felt that it may be late 2010 before the FDA would issue any formal guidance.  Still, despite the lack of immediate direction, this hearing served an important purpose for the FDA.  It is hoped that when guidance does come, it will incorporate the best of the testimony shared above.