Prescribers weigh-in on proposed label rule

A survey co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers 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 Universi-ty’s PublicMind on behalf of GPhA found strong reservations about many of the rule’s key provisions among all three groups.

The study comes as the 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

“Doctors, physician assistants and pharmacists are on the frontlines of health care in America, and large majorities said that provisions of the proposed rule would create confusion, take up essential time and impact their likelihood to prescribe generic drugs,” said Ralph Neas, president and CEO of the GPhA. “Most importantly, 81% of those surveyed believe FDA approval should be required prior to generic drug safety label changes.”

“The proposed rule raises significant concerns for practicing pharmacists, particularly in regard to patient confusion and effective risk counseling,” added Thomas Menighan, EVP and CEO of the American Pharmacists Association. “Pharmacists devote a great deal of time to counseling patients on appropriate medication use, and as the survey indicates, 67% of pharmacists asked are concerned that they will not have sufficient time to effectively address issues created by this proposed regulation.”

Other key findings of the study include:

  • 79% of physicians, pharmacists and physician assistants say they have heard “nothing” about the proposed rule;
  • 76% of prescribers and dispensers say their patients would be at least “somewhat confused” by the proposed changes, which would allow multiple safety labels for the same drug; 53% said it would be “very’ confusing even for themselves;
  • 71% anticipate the new rule would increase the amount of time they need to spend with patients reviewing patient history and the new labels;
  • 68% believe they would not have the time required to keep current with the labeling changes; and
  • 77% are at least “somewhat concerned” the proposed new rule could impact legal liabilities; even more pronounced among pharmacists (85%).
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