I just attended (via phone) the FDA’s press conference on the long awaited physician-labeling rule. A few observations:
1- Clarity saves lives. According to the FDA, approximately 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information. Research shows that prioritizing the warning information has a greater impact on reducing such events. Therefore, the new prescription label format provides the most important information about a prescription product in a format that is better understood, more easily accessible and more memorable for physicians.
2- We have hit a point of information overload. And as Surgeon General Carmona stated, “The problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information.”
3- As Deputy Commissioner Janet Woodcock pointed out, the new label must be a tool to assist doctors in counseling their patients. To wit, a new section of the label designed specifically for this purpose.
4- The urgency of e-tizing. As Deputy Commissioner Gottlieb pointed out, being able to access label information that is up-to-date, user-friendly, and on-line will put the right information in the hands of the right people at the right time.
5- Media seems to have their eyes on the prize. Early news reports crossing the wire (particularly the AP story by Andrew Bridges) are getting the story right.
I’m still waiting to hear about Senator Grassley’s statement congratulating FDA on this announcement.
Phone lines are now open.
