GPhA weighs in on FDA’s proposed quality metrics
WASHINGTON — The Food and Drug Administration is currently proposing a new quality metrics program to ensure safety and quality of generic drugs. In response to the proposed guidelines, the Generic Pharmaceutical Association’s SVP sciences and regulatory affairs, David Gaugh, issued a statement.
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Though Gaugh and GPhA support risk-based inspections to improve quality of products, he also notes that the proposed rules may go too far.
“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,” Gaugh said.
He noted that GPhA and other industry associations have urged the FDA in separate statements to avoid ambiguity in quality metrics and consider additional moves that would ensure that proposed changes won’t disrupt supply. Gaugh offers the example of a phased approach that would allow the FDA to maximize the knowledge both the industry and FDA can acquire while minimizing burdens on manufacturers. Gaugh says a phased approach would also allow manufacturers time to build infrastructure to comply with 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,” Gaugh said. “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.”