FDA pilots manufacturing quality ratings

The FDA’s manufacturing quality-ratings effort is not a new drug approval program. It is a supply-chain program aimed at figuring out which factories are more likely to keep making medicines without interruption. FDA documents describe it as part of the agency’s Quality Management Maturity, or QMM, work, a voluntary initiative run through the Center for Drug Evaluation and Research to assess how robust a plant’s quality systems are. (fda.gov) The basic problem the agency is trying to solve is older than any single shortage. (fda.gov) FDA’s 2019 report on drug shortages said many shortages begin with quality or manufacturing problems at facilities making older, lower-margin medicines, and that the market often does not reward companies for investing beyond minimum compliance. (fda.gov) FDA and White House materials later framed QMM as one of the “enduring solutions” for that problem. ### What exactly is the FDA trying to rate? FDA describes QMM as the level a manufacturer reaches when it has consistent, reliable business and production processes that support product quality and continual improvement. In practice, that means the agency is looking beyond whether a plant merely meets current good manufacturing practice rules and toward whether it detects problems early, improves processes over time and is less likely to suffer disruptions. (fda.gov) The CDER program is focused on manufacturing establishments, not on ranking drugs by clinical value. FDA says the point is to create a system that can help incentivize manufacturers to invest in more mature quality systems at their facilities. (fda.gov) ### Why does the FDA think ratings could reduce shortages? FDA’s own shortage analysis tied many supply disruptions to manufacturing quality failures, especially where there were few backup suppliers. The agency says better quality management can improve supply-chain reliability, and its quality metrics program separately says submitted manufacturing data could help the FDA improve prediction and possible mitigation of future shortages. (fda.gov) A 2022 BioPharm International report on the initiative said agency officials were trying to identify manufacturers with “more dependable production operations” after earlier efforts to encourage quality investment drew limited response. That report also said payers and health systems had been reluctant to pay more for potentially more reliable supply, one reason FDA has pursued a more visible rating approach. (fda.gov) ### Is this already a public scorecard companies can use? The program is still being developed. FDA’s QMM page says the agency has proposed a rating system and is establishing a program to promote quality management maturity, while agency white papers describe work on practice areas and prototype assessment protocols. (fda.gov) The initiative is also voluntary. FDA presentation materials say participation in the QMM program will be voluntary, which means the agency is trying to create incentives for manufacturers to join rather than imposing a mandatory grading system across the industry. ### Where could this show up in eye care? Ophthalmology relies heavily on sterile manufacturing. (biopharminternational.com) That includes eye drops, injectable drugs and perioperative medicines that can be vulnerable when a small number of plants dominate supply. The FDA materials do not single out ophthalmology, but the same manufacturing-reliability logic applies to sterile ophthalmic products because shortages often follow plant quality breakdowns or shutdowns. (fda.gov) BioPharm International said the initiative is meant to move regulators toward predicting manufacturing reliability instead of reacting after shortages appear. If FDA eventually gives purchasers and health systems a clearer way to identify more dependable facilities, that could affect sourcing decisions for ophthalmic products over time. (fda.gov) That is an inference from the agency’s stated goal of creating incentives and transparency around manufacturing quality. ### What should readers watch next? FDA’s pharmaceutical quality pages now point to continued CDER work on QMM program development, including assessment methods for manufacturing sites. The clearest public signs of progress will be new FDA program documents, pilot updates or guidance describing how facilities are assessed and whether any ratings will be disclosed more broadly. (fda.gov 1) (fda.gov 2) (biopharminternational.com)