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Healthcare Supply Chain Raises More Concerns about FDA Proposed Changes to Generic Drug Labeling

Contact: Steve Arnoff 202.249.7113


WASHINGTON, DC (April 12, 2016) — A group of 15 health care stakeholders today sent a letter to the Food and Drug Administration (FDA) expressing concerns that the FDA Proposed Rule to change generic drug label requirements could permit multiple, potentially conflicting labels for therapeutically equivalent products. The change would create provider and prescriber confusion and add significant avoidable costs to an already strained health care system.


“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,” said Chip Davis, President and CEO, GPhA. “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.”


Signatories urged FDA to “consider other approaches that do not contravene the Hatch-Waxman statute or upend 30 years of regulation.”


Physician, physician assistant and pharmacist concerns are detailed in a survey by Fairleigh Dickinson University co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare in 2014. Among the key findings:


• 81% said that FDA approval should be required before any safety label information is changed.
• 75% said that patients would be confused by multiple labels for the same medicine.
• Nearly 80% said that multiple labels would be confusing for themselves.
• 60% of prescribers said that their willingness to prescribe generic drugs would change.


A report by Matrix Global Advisors found that the Proposed Rule could increase generic drug costs by $4 billion per year. Of this, government health programs could pay an additional $1.5 billion, and private health insurance $2.5 billion for generic drugs.


“If the agency finalizes the rule as drafted, it will permit multiple, different versions of labels for therapeutically equivalent products. This would foster confusion and create unnecessary costs that could easily be avoided with more sensible regulatory solutions,” the letter continues.


“The generic and brand drug industry supported alternative, the Expedited Agency Review (EAR), meets shared public health objectives without comprising patient safety or access,” said Davis. EAR would create a system where FDA would have final authority over all potential label changes.


Click here to read the full letter.


About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.