Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series!
(Note: remember to say “SBIA” after the word “Assistance”)
Today’s topic is FDA’s Quality Metrics Reporting Program and the voluntary submission of Quality Metrics Data.
In recent years the FDA’s approach to quality oversight has evolved with the idea that quality metrics can drive improvement and monitor quality systems and processes. To this end the FDA’s Center for Drug Evaluation and Research or CDER, and the Center for Biologics Evaluation and Research or CBER, are committed to supporting the modernization of pharmaceutical manufacturing as part of the FDA’s mission to protect and promote public health.
To help achieve its mission with this evolving approach, the FDA has initiated a voluntary quality metrics reporting program to address common quality issues. The voluntary program also allows participants to submit data in the initial phase of the program. These changes will help ensure that regulatory review, compliance, and inspection policies support continuous improvement and innovation in pharmaceutical manufacturing. They may also help mitigate drug shortages by addressing the underlying causes.
The new reporting program - described in the guidance, Submission of Quality Metrics Data - has been significantly revised from the 2015 draft guidance, Request for Quality Metrics, in response to stakeholder feedback. The FDA expects that establishments are already collecting and evaluating most quality metrics data. The voluntary program will help FDA segment and support high performers, address product shortage issues, and advance operational excellence and quality practices.
FDA anticipates that most of the submitted reports will be for covered drug products or active pharmaceutical ingredients or API - used in manufacturing covered drug products. Generally, a “covered drug product” is one that is subject to a new drug application, abbreviated new drug application, biologic license application, a drug marketed pursuant to an over-the-counter monograph, or a marketed unapproved drug product.
With the voluntary program the FDA will accept both product and site reports. However, a product report for a single product that includes data from all covered establishments will be the preferred reporting method.
The FDA intends to open the electronic gateway in January 2018 to receive the voluntary submissions of data generated in 2017. The FDA then expects to begin the data analysis when the portal is closed. Next the FDA will publish initial findings on FDA’s website, and will then initiate notice and comment rulemaking to develop our mandatory quality metrics reporting program. Once the quality metrics reporting program is fully implemented, the collected information will help focus the use of FDA resources on the highest risks to public health.
The FDA recognizes that the metrics described in the guidance do not strictly determine the quality of the establishment or its products. Therefore, the FDA intends to use quality metrics information with other available knowledge to achieve the goals.
This voluntary phase of this program allows all types of drug manufacturing establishments to report information, and provides the FDA with an opportunity to use the information about participating establishments in risk-based decision making.
The FDA does not intend to take enforcement action based on quality metrics data errors in quality metrics data submission during the voluntary phase, provided that it is made in good faith.
Use of the information generated in the voluntary phase may be limited if FDA does not receive a large body of data, and it may not be representative of the industry. Industry participation will show a commitment to increasing transparency between industry and the FDA and will contribute to improving quality monitoring throughout the industry.
To encourage submissions, FDA intends to implement up to seven tools including:
- Publishing a list of the names of establishments that voluntarily report all or a subset of quality metrics data as described in the guidance on the FDA website.
- Publishing information on the quality metrics data to share how the metrics affect the frequency of current good manufacturing practice inspections.
- Obtaining feedback from participating establishments.
Additionally the FDA does not intend to publicly disclose information submitted during the program’s voluntary phase since that is considered confidential commercial information under the Freedom of Information Act.
With the publication of this revised draft guidance on the Submission of Quality Metrics Data, the FDA continues to encourage implementation of a modern, risk-based pharmaceutical quality assessment system along with the modernization of pharmaceutical manufacturing as part of the Agency’s mission to protect and promote public health.
A link to this full SBIA Chronicle article and more information about CDER’s SBIA Program can be found at: www.fda.gov/cdersbia. Thanks for tuning in!