The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

It’s the holiday season, and people everywhere find themselves frantically making purchases for those on their often hopelessly long gift lists. One of the quickest, most efficient elixirs for incurable, last-minute Christmas shopping slackers is online where shopping is literally as easy as a click of a button. Better yet, most major online retailers provide customers with a user ratings system. On any given product, ratings offer shoppers the details needed to make informed buying decisions about a product’s quality, potential risks and customers’ experience and complaints.

Though pharmaceuticals aren’t typically included on most people’s wish lists, drug-making facilities in the U.S. may soon be able to participate in a regulatory ratings system that quantifies the level of their drug manufacturing quality. (1) This comes after recent findings in a U.S. Food and Drug Administration (FDA) report on the causes of pharmaceutical shortages showed that manufacturers aren’t operating on a level playing field when it comes to the quality management practices of their products. (2)

Unboxing the Problem

In October 2019, the FDA released the results of the study conducted by an inter-agency Drug Shortage Task Force at the request of Congress. Its findings zeroed in on three root causes of drug shortages:

1. Lack of incentives for manufacturers to produce less profitable drugs;
2. The market fails to recognize and reward manufacturers for “mature quality management systems” that put a premium on continuous improvement and early detection of supply chain issues; and
3. Logistical and regulatory challenges make it difficult for the market to recover from a drug shortage disruption.

More specifically, the report states that many pharma companies’ manufacturing sites skate by with the bare minimum when it comes to complying with current good manufacturing practices (CGMP). This is due to the fact that there simply aren’t any incentives for these companies to seek “more advanced levels of quality management,” the report stated. Manufacturers that invest in improved production technologies and digital quality management solutions that offer proactive quality assurance simply aren’t rewarded or compensated “with price premiums for mature quality management,” the task force said.

Drug company facilities that observe minimum CGMP and quality standards and rely on outdated technology, such as paper-based data systems, can experience deviations, longer review times and recalls that impact the supply chain and result in shortages. For generic drugs in particular, the market often offers few rewards for companies to invest in updated manufacturing technologies and improvements in their quality management. And even when manufacturing facilities chose to invest in quality manufacturing upgrades, there isn’t always a method to “identify measures of quality that could be used to predict operating outcomes, such as shutdowns of manufacturing lines resulting in supply disruptions,” the report states.

Erin Fox, senior director of drug information and support services at the University of Utah, supports a new letter-grade rating system for manufacturers’ sites, according to RAPS’ Regulatory Focus.(3) ““The pass fail system we have isn’t working – pharma companies have no incentive to have high quality… we spend billions of dollars on drugs without knowing which company makes them, where they are made, and where their raw materials come from – what else do we buy without this most basic information?”

As mentioned previously, one of the potential solutions to the drug shortage problem recommend by the task force is the creation of a voluntary new system to measure and rate the quality management maturity of individual drug manufacturers’ facilities based on objective criteria. It would also create greater transparency and trust between pharma manufacturers and buyers about the quality and content of products.

Presenting Solutions

While a ratings system remains merely a proposal at this point, FDA officials don’t appear to be opposed to the idea as it may help fill the current “quality maturity gap” that exists between manufacturers. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said it’s her hope that the task force’s recommendation spurs more conversation within the industry. If a ratings system is created, the agency says that buyers, particularly group purchasing organizations that supply hospitals and consumers, will recognize and reward manufacturing quality maturity.

“This could be done through a number of different mechanisms, such as paying higher prices for drugs manufactured at top-rated facilities, requiring a certain quality maturity rating as a condition of contracting, or guaranteeing purchase of a set volume of products from sites achieving a certain maturity rating,” the task force’s report states.

The FDA did clarify that the proposed ratings system is a completely separate program from its plans for a mandatory quality metrics pilot program under which manufacturers would report key quality manufacturing metrics to the agency.

Whether the ratings system comes to fruition or not, the good news is that there are advanced, data-centric quality manufacturing solutions available to pharma companies now to help them boost production efficiencies and lower costs. Best-in-class automated quality management systems (QMS) can drive proactive versus reactive quality by connecting various production systems and ensuring quality and compliance across the product life cycle. And because digitization takes quality manufacturing to an entirely new level, a digital production records solution can be integrated into your existing production systems, eliminating the human errors and delays caused by disparate paper-based data systems.

A combined platform of a digital QMS and an electronic batch records (EBR) solution provide pharmaceutical companies with a centralized, data-driven capability to identify and mitigate shop floor issues before they become larger problems. A digitized product lifecycle platform also gives manufacturers the capacity to reduce batch record cycle times, purge common data entry errors and increase your product speed to market.

Conclusion

A voluntary ratings system that lets drug manufacturers signal to buyers their commitment to heightened manufacturing quality maturity could be a gift bonanza. It would provide pharma companies with an objective, quantifiable means to differentiate themselves from the competition while presenting buyers with better informed purchasing options. Whether a potential drug manufacturing quality rating system is on your wish list or not, the concept aligns with recent FDA efforts for greater transparency in regulatory processes and tangible incentives to improve quality.

References:

1. “FDA Task Force Recommends Rating System for Drug Manufacturing Quality” by Zachary Brennen. Regulatory Focus of the Regulatory Affairs Professionals Society (RAPS). Oct. 29, 2019. https://www.raps.org/news-and-articles/news-articles/2019/10/fda-task-force-recommends-rating-system-for-drug-m
2. “Drug Shortages: Root Causes and Potential Solutions” The U.S. Food and Drug Administration (FDA). Oct. 29, 2019. https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions
3. “FDA Floats Idea of Rating System for Drug Manufacturers” by Zachary Brennan. Regulatory Focus, RAPS. Oct. 25, 2019. https://www.raps.org/news-and-articles/news-articles/2019/10/fda-floats-idea-of-rating-system-for-drug-manufact