On Monday, the US Food and DrugAdministration (FDA) held a public meeting to discuss its plan to requestquality metrics from drug manufacturers. The meeting was the first opportunityfor the agency and industry to publicly discuss the plan since FDA released itsdraft guidance in July.

While many questions about the programremain, the agency provided some clarification for industry and said it wouldnot be releasing its final guidance until 2016. The agency is also extendingthe comment period on the draft guidance by an additional 60 days, givingindustry until 27 November 2015 to submit its feedback.

Background

For the past few years, FDA has beenconsidering measures to improve and better understand drug quality. Theagency's efforts were reinforced in 2012 with the passage of the Food and DrugAdministration Safety and Innovation Act, which allowed the agency to useperformance measures "to assess a facility's quality systems to assureproduct quality."

In July 2015, after years of discussions,FDA released its draft guidance, Request for Quality Metrics, explaining theagency's general approach to quality metrics and requesting industry input oncertain areas still being considered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

FDA said it plans to ask manufacturers forcertain quality metrics to "improve the efficiency and effectiveness"of its inspections, claiming the information could be used "to reduce theinspection frequency at an establishment." FDA said its authority undersection 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 witha legal basis to request quality metrics from companies.

What Kinds of Data is FDA Looking for?

While many companies use specific qualitymetrics internally, there are no standards for what metrics are measured. Tobegin, FDA has released a list of 10 baseline quality metrics it isconsidering, including metrics such as the number of lots attempted for aproduct and the number of quality-related complaints a product receives. Theagency is also considering five optional metrics to gauge companies'"commitment to quality."

I

ndustry Response

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

Speaking for the Pharmaceutical Researchand Manufacturers of America (PhRMA), Camille Jackson said that herorganization supported "FDA's efforts to introduce a risk-based inspectionprogram" that would "incentivize quality and promote qualitycultures."

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

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

Finally, Jackson indicated that FDA maylack "legal authority to require manufacturers todevelop and submit the requested quality metrics data," and encouraged theagency to "promulgate new requirements through binding rulemaking."

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

Gaugh also asked FDA to ensure thatindustry has enough time to prepare for any new reporting requirements, andexpressed concern that FDA would consider failure to supply therequested quality metrics as "equivalent to refusing an inspection."

Closing Remarks From FDA

In closing, Russell Wesdyk, acting directorof FDA's Office of Surveillance in the recently formed Office of PharmaceuticalQuality, reassured industry that FDA is committed to continued dialogue onquality metrics and acknowledges the industry's calls for a phased orrisk-based approach to implementing a quality metrics program.

Wesdyk also told the audience FDA wouldgive industry time to prepare for any requirements after a final guidance isissued next year, and would also issue an update on the program six monthsafter the first set of metrics are submitted and used. Wesdyk also said thatquality metrics would not be used in isolation to make any regulatorydecisions.

Additionally, in response to the number of questions and concerns raised at the meeting, FDA will be extending the commentperiod on the draft guidance by 60 days, giving industry until 27 November2015 to submit its feedback.

Draft Guidance for Industry; Request for Quality Metrics (PDF - 250KB)

Recordings of Meeting:

·        https://collaboration.fda.gov/p5yt8ic6m55/

·        https://collaboration.fda.gov/p90cd5hnx3c/

Presentations (Attached)

• Quality Metrics Overview, Ashley Boam, MSBE, Acting Director, Office of Policy and     Pharmaceutical Quality, FDA/CDER (PDF - 98KB)


• Request for Quality Metrics: Technical Specifications, Ron Fitzmartin, PhD, MBA,     Senior Advisor, Office of Strategic Programs, FDA/CDER (PDF - 542KB)    


• ISPE Comments, Diane Hagerty, Vice President, Genentech Inc. (PDF - 57KB)
      


• FDA Request for Quality Metrics, John S. Punzi, Ph.D., Director, Quality Assurance and     Technical Affairs, Consumer Healthcare Products Association     (CHPA) (PDF - 186KB)


• PDA's Quality Metric Public Meeting Comments, R.M. Johnson, President,     Parenteral Drug Association (PDA) (PDF - 769KB)


• Quality Metrics Public Meeting, David R. Gaugh, R.Ph., Senior Vice President for     Sciences and Regulatory Affairs, Generic Pharmaceutical Association     (GPhA) (PDF - 337KB)


• IPEC-Americas     Verbal Comments for Quality Metrics Guidance Public Meeting, Priscilla     Zawislak, International Pharmaceutical Excipients Council (IPEC) (PDF     - 80KB)


• FDA Public     Meeting: Request for Quality Metrics, Alan W. Nicholls, Chair, Bulk Pharmaceuticals Task Force (BPTF) (PDF - 150KB)