Quality Metrics: Industry Reaction to FDA's Draft Guidance

Regulatory NewsRegulatory News | 25 August 2015 |  By 

On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July.

While many questions about the program remain, the agency provided some clarification for industry and said it would not be releasing its final guidance until 2016. The agency is also extending the comment period on the draft guidance by an additional 60 days, giving industry until 27 November 2015 to submit its feedback.


For the past few years, FDA has been considering measures to improve and better understand drug quality. The agency's efforts were reinforced in 2012 with the passage of the Food and Drug Administration Safety and Innovation Act, which allowed the agency to use performance measures "to assess a facility's quality systems to assure product quality."

In July 2015, after years of discussions, FDA released its draft guidance, Request for Quality Metrics, explaining the agency's general approach to quality metrics and requesting industry input on certain areas still being considered by the agency.

FDA said it plans to ask manufacturers for certain quality metrics to "improve the efficiency and effectiveness" of its inspections, claiming the information could be used "to reduce the inspection frequency at an establishment."

FDA said its authority under section 704(a)(4)(A) of the Food, Drug, and Cosmetic Act to collect records "in advance of or in lieu of" an inspection provides the agency with a legal basis to request quality metrics from companies.

What Kinds of Data is FDA Looking for?

While many companies use specific quality metrics internally, there are no standards for what metrics are measured.

To begin, FDA has released a list of 10 baseline quality metrics it is considering, including metrics such as the number of lots attempted for a product and the number of quality-related complaints a product receives.

The agency is also considering five optional metrics to gauge companies' "commitment to quality."

Industry Response

Several groups representing the pharmaceutical industry gave feedback and shared both their concerns and support over FDA's plan to request and use quality metrics.

Speaking for the Pharmaceutical Research and Manufacturers of America (PhRMA), Camille Jackson said that her organization supported "FDA's efforts to introduce a risk-based inspection program" that would "incentivize quality and promote quality cultures."

The challenge, she said, is in "finding meaningful correlations between quality risks and discrete metrics that attempt to broadly measure performance, capability and culture."

Furthermore, PhRMA asked FDA to provide more explicit detail as to how the agency will use quality metrics and encouraged the agency to continue collaboration between its centers and with industry as it develops its quality metrics program.

Finally, Jackson indicated that FDA may lack "legal authority to require manufacturers to develop and submit the requested quality metrics data," and encouraged the agency to "promulgate new requirements through binding rulemaking."

Speaking for the Generic Pharmaceutical Association (GPhA), David Gaugh echoed the concern that FDA may not have the authority to require companies to provide quality metrics data. Gaugh said that while the agency has the authority to request and inspect records already kept; it does not have the authority to require companies to generate new records.

Gaugh also asked FDA to ensure that industry has enough time to prepare for any new reporting requirements, and expressed concern that FDA would consider failure to supply the requested quality metrics as "equivalent to refusing an inspection."

Closing Remarks From FDA

In closing, Russell Wesdyk, acting director of FDA's Office of Surveillance in the recently formed Office of Pharmaceutical Quality, reassured industry that FDA is committed to continued dialogue on quality metrics and acknowledges the industry's calls for a phased or risk-based approach to implementing a quality metrics program.

Wesdyk also told the audience FDA would give industry time to prepare for any requirements after a final guidance is issued next year, and would also issue an update on the program six months after the first set of metrics are submitted and used. Wesdyk also said that quality metrics would not be used in isolation to make any regulatory decisions.

Additionally, in response to the number of questions and concerns raised at the meeting, FDA will be extending the comment period on the draft guidance by 60 days, giving industry until 27 November 2015 to submit its feedback.


Federal Register


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