Under the revised draft, FDA says the program will begin with a voluntary phase that will run into 2018, after which the agency says it intends to make the program mandatory.
The revised draft guidance also narrows the scope of the program by cutting the number of metrics the agency plans to ask for, and allows companies more flexibility with quality metrics reporting by both product and site.
"The revised draft guidance includes the following changes from the earlier draft guidance: Adoption of a phased-in (voluntary) approach, reduction in the number of data elements requested (i.e., reduction in reporting burden), support for both product reports and site reports, modifications to the quality metrics data definitions, addition of clarifying examples for the definitions, addition of comment fields, and clarification of special considerations for non-application and OTC [over-the-counter] product reporting," FDA says.
The agency calls on drugmakers to provide data for three different primary metrics, instead of the four primary and three optional metrics it initially proposed:
- Lot acceptance rate (LAR)
- Product quality complaint rate (PQCR)
- Invalidated out-of-specification Rate (IOOSR)
Following the release of the initial draft guidance in July 2015, industry groups pushed back against FDA's proposal, asking FDA to be more forthcoming with how it would use the quality metrics, and questioning the agency's legal authority to mandate such a program.
Speaking at a public hearing in August 2015, Pharmaceutical Researcher and Manufacturers of America (PhRMA) questioned whether FDA had the "legal authority to require manufacturers to develop and submit the requested quality metrics data," without going through the necessary steps of a rule.
Heeding those concerns, FDA says it now "recognizes that a voluntary phase of the program would give participants an opportunity to demonstrate transparency and a willingness to proactively engage with the Agency in pursuit of the goals described in the revised draft guidance."
However, FDA cautions that it may not be able to achieve its goals for the program through voluntary reporting alone. "If FDA does not receive a large body of data from reporting establishments, the ways in which the Agency can use the information may be limited," FDA says.
As such, the agency says it will narrow its focus during the voluntary phase of the program to three areas:
- "Working with establishments towards early resolution of potential quality problems and to reduce the likelihood that the establishment's operations will be disrupted and impact the drug supply,
- helping to prepare for and direct [FDA] inspections, and
- use of the calculated metrics as an element of the post-approval manufacturing change reporting program with an emphasis on encouraging lifecycle manufacturing improvement."
Other Changes and Updates
The revised draft guidance also features a number of other changes from the initial version.
FDA says it will allow companies to submit quality metrics reports by product or site. Initially, FDA proposed requiring quality metrics reports to be segmented by product, but industry objected, calling for more flexibility from the agency. However, FDA says it still encourages reporting by product, "because it demonstrates a certain level of oversight and controls over the manufacturing of drug products across the supply chain."
FDA also says it will allow companies to submit comments of up to 300 words explaining the data in the reports or discuss plans for improvements.
Additionally, FDA says it plans to release a new version of the Technical Conformance Guide it released last June in line with the revised draft guidance.