Adverse Event Reporting Commentary Leads Day 2 of FDA Social Media Hearings: MedWatch a Focal Point
From Jim Weinrebe, live from the hearings:
Look for MedWatch to become an increasingly "go to' website for consumers experiencing problems they believe are associated with their prescription therapies.
We're barely 30 minutes into the morning's agenda on what Internet regulations should exist for adverse event reporting, and two speakers have already spotlighted the need to make the MedWatch site more consumer-friendly and accessible. One speaker represented Consumer's Union, and the other was a woman whose husband commited suicide after taking anti-depressants that were associated with the potential for suicidal tendencies.
Both speakers urged FDA to actively promote the MedWatch site to consumers, with one noting that most consumers aren't even aware of its existence and what it's used for. Promotion of MedWatch should be supplemented by modifying its language and process to facilitate easier use by consumers in the reporting of adverse events, the speakers both noted.
The Consumer Union spokesperson stated that manufacturers should be required to post prominent links on any website not only specific to a branded drug, but also non-branded disease awareness sites controlled by the company and even third party group websites of which the manufacturer is a substantial sponsor.
Looking down the road, highlighting MedWatch and facilitating links to the site appear to be a likely point of consensus among all parties. It makes a ton of sense from both a public health and industry reporting burden perspective. More to come.
Posted by Lloyd Benson on November 13, 2009 at 10:06 AM
