Class I Recalls Climb in Fiscal Year 2006

Rockville, MD (Oct. 20)-The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER, www.fda.gov) executed 45 Class I, 193 Class II, and 128 Class III recalls of human drugs between Oct. 1, 2005 and Sept. 30, 2006.

In a statement made at the 2006 Generic Pharmaceutical Association Fall Technical Conference on Oct. 19, CDER Office of Compliance Acting Deputy Director Joe Famulare called the Class I figures, which represent the most serious drug recalls, “very significant” because only one or two such recalls occur in most years.

According to the Drug Industry Daily (DID, Oct. 23), the Class I recalls “signals a fundamental shift in enforcement policy for an agency still reeling from criticism over recent drug safety incidents.” The rise of Class I recalls, DID reported, could mark the start of a trend where the agency will be more prone to label recalls as Class I because of recent drug safety criticism.

Others believe that the numbers are more closely tied to manufacturing quality problems than drug safety. The top reasons for recalls, Famulare noted, included subpotency in single-ingredient drugs, impurity, defective containers, nonsterile products, and superpotency. The recalls include drugs for which new drug applications or abbreviated new drug applications have been submitted as well as some CDER-regulated biologics.