FDA Proposed Rule to Change Label Requirements Would Cause Dangerous Confusion, Raise Costs



(ORLANDO, FLORIDA, February 21, 2014) — The Food and Drug Administration (FDA) Proposed Rule to change prescription drug label requirements risks the safety of millions of patients, according to today’s expert panel, Labeling: Patient Safety and Politics, convened at the Generic Pharmaceutical Association (GPhA) Annual Meeting in Orlando.

“The first priority of GPhA and its member companies is patient safety,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. “The Proposed Rule can be improved. For instance, the current draft allows for multiple different labels for medicines that chemically are the same. This would cause dangerous confusion and have harmful consequences for patients, prescribers, pharmacists and others throughout the health system.”

According to panelist Bob Pollock, MS, R.Ph., Senior Advisor, Lachman Consultants, former Acting Deputy Director at the Office of Generic Drugs, “This Proposed Rule will create the chaos that FDA has sought to avoid for more than 30 years. Utilization of generic drugs is based on the ‘sameness’ requirements between brand and generic labels — this sameness is what reassures the health system and the millions of patients that rely on generics that a generic drug is as safe and effective as its brand counterpart.”

Panelist Scott Gottlieb, MD, Resident Fellow at the American Enterprise Institute and former senior FDA official, pointed out that the Proposed Rule upsets a vibrant marketplace for millions of patients while benefitting few:

“The fact is that this measure was not crafted to improve safety or advance public health. It is part of a political effort by the Obama Administration to achieve through executive action what the Administration failed to accomplish in the courts or through legislation. This measure is based on a flawed premise and will jeopardize the thriving low-cost market for generic medicines. There are far better means for making sure drug labels reflect up to date information. If the FDA implements this rule intact, it will fall short of benefitting public health. Rather, it will stoke a mountain of litigation at the expense of millions of patients.”

GPhA continues to call for a multi-stakeholder collaboration to illuminate the implications of the Proposed Rule and identify a workable solution.

“Efforts from multiple stakeholders to amend and streamline the current Proposed Rule are critical. Together, we can find a way forward without opening the door to the unintended and deleterious public health consequences of the current language,” said Neas.


Matrix Global Advisors (MGA) report: FDA’s Proposed Generic Drug Labeling Rule: An Economic Assessment

GPhA Overview and Assessment: Food and Drug Administration’s Proposed Rule Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Infographic: FDA Proposed Rule Would Cause Dangerous Confusion, Economic Side Effects

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