Statement by David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA:
WASHINGTON, DC (Nov. 30, 2015) - "The Generic Pharmaceutical Association (GPhA) shares with the Food and Drug Administration (FDA) a strong commitment to quality. As such, GPhA supports risk-based inspections to drive quality improvements. However, the agency's proposed quality metrics program exceeds its statutory authority and could require manufacturers to make significant and unsubstantiated changes with potential to disrupt the manufacturing process, making it harder to ensure timely access to safe and effective generic drugs.
In separate comments to the agency, GPhA and a broad group of industry associations and technical groups urge FDA to avoid ambiguity in quality metrics and consider additional actions to make sure any proposed changes do not cause supply disruptions. For example, the quality metrics program could start with a phased introduction. A phased approach is one way to maximize learnings for industry and FDA while limiting avoidable burdens on manufacturers. A phased approach can also ensure that the nation's generic and brand pharmaceutical manufacturers are able to develop the infrastructure needed to comply with these new inspections.
A well-designed quality metrics program can lead to a proactive system where the FDA and industry can continue to collaborate and improve drug quality. Working together, the industry and the FDA can refine quality metrics to help ensure that new treatments can be developed and that safe and effective generic drugs can continue to expand access and increase health savings for millions of people."
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.
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