New proposed federal rules released this week aim to track how production and facility problems lead to a shortage of certain drugs.
The Food and Drug Administration on Monday issued draft guidance that provides a blueprint for applying metrics to evaluate the quality of the facilities and production processes involved in the making of FDA-approved branded, generic and biologic prescription medications.
“It's critically important for patients, healthcare professionals, caregivers, payers and others to have confidence in how medications are made,” FDA officials wrote in a blog post on Tuesday. “Quality metrics, or the measures used to assess the quality of drug and biologic manufacturing, can help us achieve this goal.”
The blog was co-written by Ashley Boam, acting director of pharmaceutical quality policy at the FDA's Office of Pharmaceutical Quality, and Mary Malarkey, FDA director of biologics quality compliance within the agency's Center for Biologics Evaluation and Research.
Under the guidance, pharmaceutical manufacturers would compile data based on the agency's set of metrics. The FDA would collect records in order to conduct what it calls “risk-based inspection scheduling,” where the frequency with which a manufacturer is inspected would be based on the amount of quality metric data it provides.
“FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments,” the draft stated. “For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection).”
The guidelines are the latest in a series of FDA initiatives to identify potential risk factors within the manufacturing process that could lead to disruptions in drug supplies and cause shortages of much-needed medications.
Many, including the FDA have cited poor quality standards at a number of facilities as the reason for product defects and, ultimately, supply disruptions while the manufacturer identifies the defect.
There were 219 active drug shortages in the U.S. as of June 30, according to figures from the University of Utah Drug Information Service. That is a marked decline from the more than 300 reported at the end of 2014 but is still a 44% increase over 152 reported in 2010. Manufacturing problems are cited as a leading cause for supply disruptions, which according to the service accounted for a quarter of all drug shortages in 2014.
The FDA will take public comments on the proposed guidance until September 2015 with plans to hold a public meeting in August.
