Class I Recalls Climb in Fiscal Year 2006

News
Article

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration's Center for Drug Evaluation and Research executed 45 Class I, 193 Class II, and 128 Class III recalls of human drugs between Oct. 1, 2005 and Sept. 30, 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.

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes