Users blast availability of MedGuides

Share this article:
The FDA's Medication Guide (MedGuide) program was the object of intense criticism from reps of retail pharmacy organizations, consumer groups and academic researchers at a public hearing by the agency in June.

Congressman Michael Ferguson (R-NJ), expressed concern that, although the FDA has authority to require manufacturers to provide MedGuides for selected products, monitoring to assure they are available at pharmacies is largely left to individual state pharmacy boards. He was skeptical that pharmacy boards in every state are assuring compliance or, in some cases, are even aware of their responsibilities in this area. Ferguson urged FDA to grant more “flexibility” in acceptable MedGuide formats and he strongly endorsed the concept of e-distribution.

E-distribution proposals were also endorsed by Tom Lawlor, an executive with the Walgreen Company.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.

Five things for Pharma Marketers to Know: Thursday, August 28

Five things for Pharma Marketers to Know: Thursday, ...

Human testing of GSK's Ebola virus starts next week, menopause is a costly healthcare concern, and a small conversation with pharmacists may have a big impact.