Users blast availability of MedGuides

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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.

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