Feedback from early adopters of quality metrics, manufacturers who implemented quality metrics programs to address manufacturing problems, and independent academic research indicates that a manufacturer’s overall quality program benefits from the use of quality metrics. In June 2018, FDA announced two new voluntary programs - the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program - in response to stakeholder requests for continued dialogue on quality metrics and to provide methods for industry to inform FDA’s use of quality metrics in the future. The Q&A below provides more information regarding the two programs.

1. Are companies limited to submitting a proposal to either the Site Visit Program or the Feedback Program?

   No, a stakeholder may submit a separate proposal to both programs. The Site Visit Program provides an opportunity for engagement and in-depth discussions to take place at a manufacturing establishment and enables FDA to observe the implementation of the quality metrics and quality culture programs at the site. We can see how the data is gathered and used to drive decision-making and talk to employees from different functional areas of the company. The Feedback Program allows for shorter meetings that may occur at recurring frequency during the year, enabling back-and-forth clarification and discussion.

   Note that we may need to limit our number of site visits due to resource constraints. For example, it may be more valuable to FDA to first learn about a stakeholder’s program via a site visit and to subsequently continue discussions via the Feedback Program. The company may also request to participate in the Feedback Program, as long as the request is submitted by July 28, 2019. We encourage participation in either or both programs, and stakeholders can reach out to us with questions about which program is best for them (OPQ-OS-QualityMetrics@fda.hhs.gov).

2. Will the information shared and discussed with FDA as part of these programs be protected from disclosure or will it be publicly available via FOIA?

   FDA does not intend to publicly disclose information submitted to the Agency as part of this Quality Metrics Feedback and Site Visit Programs that is exempt from disclosure under disclosure laws and regulations. Consistent with how FDA handles information gathered on inspection, the following types of information will be exempt from public disclosure if not made public by the owner: (1) commercial relationships; (2) production and sales volume; (3) business plans; and (4) unapproved applications. FDA also does not intend to share this information with other government agencies without permission by the owner.

3. How will FDA handle information shared during the Feedback or Site Visit program which suggests a quality problem?

   As this is for learning purposes only, FDA does not intend to draw conclusions from the information shared and these programs are not intended to supplement or replace a regulatory inspection or application assessment

Site Visit Program

1. Will an FDA-482, Notice of Inspection, or FDA-483, List of Observations, be issued at the start or close of the site visit?

   No. The visit is not considered an inspection pursuant to Food Drug & Cosmetic Act Section 704. The Site Visit program is an experiential learning opportunity for CDER, CBER, and ORA staff to learn firsthand about specific company programs. It provides an opportunity for stakeholders to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program.

2. What is the general timeframe for FDA Site Visits?

   We plan to conduct site visits between January and September 2019. This may be extended depending on resources and availability.

3. From FDA, who will participate in the Site Visit and Feedback programs?

   CDER, CBER, and ORA staff have been involved in the development of the Quality Metrics Program and may be participate in these programs.

Feedback Program

1. Do any data, quality metrics program, or overall quality metrics strategy submitted in advance of a Type C or pre-ANDA meeting become part of the application submission and therefore approved?

   No. The information is to facilitate engagement between the stakeholder and FDA staff involved in the Quality Metrics Program, and it does not become part of the application submission.

2. Where will the meetings be held?

   Meetings may either be held at FDA’s White Oak campus in Silver Spring, MD or virtually. FDA can arrange the virtual meetings.

3. What should a sample Feedback Program submission (i.e., Type C, pre-ANDA, or pilot) include?

   The request for a meeting and submission to the pilot program is described in Section II and III of the Federal Register notice. We are very much interested in understanding the quality metrics that are most meaningful for companies and for particular product(s), the definitions of those metrics, quality metrics data for specific products, including historical and current data, the management and oversight of the program, as well as the company’s approach to assessing and overseeing quality culture.

4. What topics may be included in the Feedback Program meeting request or submission to the pilot program (i.e., Type C, pre-ANDA, pilot)?

   FDA is interested in learning specifics about a company’s experience with their quality metrics and culture program and the elements of the program that they find important. Therefore, we encourage including any topic relevant to this outcome and associated case studies to assist in the learning process. Further, a company has the flexibility to include or exclude topics in their meeting request or submission to the pilot program. Example meeting topics include:

   (1) which quality metrics are used and why;

   (2) definitions of metrics data elements across a company to facilitate comparison of the quality metrics over time and across multiple sites (if applicable);

   (3) how the metrics are used by site and corporate management (e.g., initiating continual improvement activities);

   (4) current approach to quality culture assessment, improvement, and management.