US health care providers have concerns on proposed FDA generic drug labeling rules

A survey co-released today by the USA’s Generic Pharmaceutical Association (GPhA) and the National Coalition on Healthcare reveals that the health care providers on which patients rely most to explain safety information about their prescription drugs have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.

A random phone survey of 150 physicians, 150 physician assistants and 150 pharmacists conducted by Fairleigh Dickinson University’s PublicMind on behalf of the GPhA, found strong reservations about many of the rule’s key provisions among all three groups.

The study comes as FDA considers more than 100 responses to its controversial proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which would dramatically alter the current regulations to allow generic medicine manufacturers to change their safety labels without prior FDA review and without immediate access to the drug’s complete safety data.