New Survey Shows 81% of Doctors, Physician Assistants and Pharmacists believe FDA Approval Should Be Required Prior to Generic Drug Safety Label Changes



WASHINGTON, DC (June 18, 2014) — A survey co-released today by the Generic Pharmaceutical Association (GPhA) and the National Coalition on Healthcare reveals that the healthcare providers patients rely on most to explain safety information about their prescription drugs have serious concerns about a proposed Food and Drug Administration (FDA) 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 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.

“Doctors, physician assistants and pharmacists are on the frontlines of healthcare 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. And most importantly, 81% of those surveyed believe FDA approval should be required prior to generic drug safety label changes. Their voices need to be heard,” said Ralph G. Neas, President and CEO of GPhA.

“The proposed rule raises significant concerns for practicing pharmacists, particularly in regard to patient confusion and effective risk counseling,” said Thomas E. Menighan, Executive Vice President and CEO of the American Pharmacists Association (APhA.) “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.”

"Thousands of physicians, physician assistants and pharmacists who work in America’s hospitals rely on consistent safety information to make informed decisions about patient care,” said Rick Pollack, Executive Vice President of The American Hospital Association. “Label safety information is critical for patients and their caregivers, and this new research raises the probability of unintended consequences.”

“This new research indicates that physician and health professionals concerns about the proposed rule could significantly increase healthcare costs,” said John Rother, National Coalition on Health Care President and CEO. “For instance, 60 percent say the proposed rule would have at least ‘some’ impact on their willingness to recommend generic drugs in the future. Given that generic drug use has generated more than $1.2 trillion in savings to the U.S. health care system over the past decade, and saved $217 billion in 2012 alone, this could undermine the sustainability of our healthcare system.”

Other key findings of the study include:

  • News of the proposed new generic drug labeling rule has not yet reached physicians, pharmacists or physician assistants; in fact 79 percent say they have heard ‘nothing’ about this rule.
  • Prescribers and dispensers both expressed the belief that by allowing multiple versions of labeling for the same drug, the proposed new rule would lead to confusion in the marketplace. Most (76%) say their patients would be at least somewhat confused, while more than half (53%) say having multiple safety labels would be ‘very’ confusing for themselves.
  • Most believe the new rule would have a negative impact on their time. 71% anticipate the new rule would increase the amount of time they need to spend with their patients reviewing patient history and the new labels; 74% percent believe it would have at least some impact on the time they will need to spend researching labeling differences;
  • Equally as important, most (68%) believe they would NOT have the time required to keep current with the labeling changes.
  • Concerns regarding liabilities are also an issue, as 77 percent are at least somewhat concerned the proposed new rule could impact their legal liabilities. This concern is even more pronounced among pharmacists (85%).

The full survey results are available here.

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