In a follow-up to my post on this issue early yesterday, GPhA announced that 21 pharmacy groups were signatory to a letter to Commissioner Margaret Hamburg, imploring her to reconsider the Proposed Rule on labeling changes in its current form.
These are the organizations that represent pharmacists, payors, pharmacy benefit managers, wholesalers and the boots-on-the-ground that truly understand the implication of permitting unilateral label changes by generic manufacturers. They understand the unintended consequences that will fall upon the healthcare system. I won’t repeat myself a third time, but will simply reference you to the letter the groups co-signed and let you reach your own conclusion. After reading the letter – who do you think knows better? The letter can be found here.
With the March 13th deadline for comments on the Proposed Rule fast approaching, it is time to contact your Congressional representatives, the FDA and anyone else that will listen. Let’s not permit the FDA to create the confusion that for 30 years they have been trying to avoid. There are other ways to reach the same objective without creating chaos in the marketplace and adding billions of dollars that will be passed onto the government and consumers.