FDA proposed rule could increase generic drug costs, say industry groups

Fifteen stakeholders, including American Pharmacists Association (APhA), National Association of Chain Drug Stores (NACDS) and Public Sector HealthCare Roundtable (PSHR), expressed concerns to the Food and Drug Administration (FDA) regarding proposed changes in generic drug labeling. 

The proposed changes could allow manufacturers to produce conflicting labels for equivalent products.

“The FDA proposed rule on generic drug labeling invites unintended consequences that would be detrimental to patient safety, hinder the ability of health experts to do their jobs, and drive up drug costs,” Generic Pharmaceutical Association (GPhA) President and CEO Chip Davis said. “Health professionals agree that the FDA alone has the breadth of proprietary product information to make safety label decisions. Generic drug manufacturers should not be changing label information unilaterally without prior FDA approval.”

Allowing unapproved changes to labels could confuse providers and increase costs for generic drugs. A survey released by the GPhA and National Coalition on Healthcare in 2014 found that 81 percent of physicians, physician assistants and pharmacists believe that changes in safety labels should require FDA approval. Other concerns included patient and prescriber confusion over differing labels on the same medication.

The stakeholders favor alternatives that rely on the FDA to review and approve safety information on generic drug labels. The FDA is the only organization with full access to all generic drug manufacturers' product information.

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