FDA Floats Idea of a Rating System for Drug Manufacturers

Regulatory NewsRegulatory News | 25 October 2019 |  By 

The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities.

“This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, wrote in a blog post published Thursday. “Should they choose to disclose this rating, group purchasing organizations and other purchasers could require disclosure of the rating in their contracts with manufacturers.”

The idea of a drug manufacturing ratings program follows the revelation that many drug shortages occur in the US because of quality issues. A team of FDA economists examined a sample of 163 drugs that first went into shortage between 2013 and 2017 and found that 62% were associated with manufacturing or product quality problems. FDA also previously highlighted a relative surge in drug shortages in 2018.

Erin Fox, senior director of drug information and support services at the University of Utah, told Focus she supports a new system that would give manufacturers letter grades, explaining: “The pass fail system we have isn’t working – drug 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?”

But the Pharma and Biopharma Outsourcing Association (PBOA) questions how the FDA’s ratings system will be set up.

Gil Roth, president of PBOA, told Focus: "We think FDA's Quality Metrics (which will be used to generate the letter grades) are flawed and won't give accurate site-specific quality ratings, and FDA seems to be ignoring our statements and evidence on this."

Other industry groups and companies previously raised questions with FDA’s plans for a mandatory quality metrics program. And although the agency developed voluntary pilots to further develop it, Alicia Mozzachio, senior advisor for international activities at FDA, said: “Voluntary reporting alone may not be sufficient to accomplish FDA’s goals for the program.”

Woodcock also further explained how this rating system “would introduce transparency into the market, and provide companies committed to quality management maturity with a competitive advantage, potentially enabling them to obtain sustainable prices as well as grow market share.”

She also co-authored an article in Clinical Pharmacology & Therapeutics in 2013 that explained how quality is not always transparent at sterile injectable manufacturing facilities.

“Defects in sterile injectable products can be difficult to detect because microbial contamination may be non-uniform and episodic. This lack of uniformity can confound conventional sampling plans. In addition, microbial contamination can increase after production, which means that more sensitive testing must be done at production time. For these reasons, the FDA has made attempts over the last few years to enhance its audit of a site’s state of control and quality problems by developing a cadre of highly trained and experienced inspectors to conduct inspections of complex facilities such as those that produce sterile injectables,” Woodcock wrote.

Janet Woodcock Blog Post


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