The FDA recorded an increase in drug recalls--a rise of more than 54%--for the third quarter of 2011 compared with the second quarter. In 150 callbacks (versus just 97 in the second quarter), manufacturers directed the return of nearly 30 million pharmaceutical units.
"Regulatory oversight has been increasing and we do expect this trend to continue," says Mike Rozembajgier, VP for Recalls at Stericycle ExpertRECALL, in an email. The findings are detailed in the recall-management specialist's third-quarter index, issued last week.
Although the number of recalls jumped dramatically, the index recorded a 16% drop in the number of units called back. Second-quarter recalls involved 35 million units.
The index includes food, medical devices, consumer products, and children's and infants' products in addition to drugs. The proportion of pharma's recall rise topped all other categories.
"The FDA has stepped up its oversight of U.S. manufacturing plants and operations. And with the U.S. Government Accountability Office's recent call for the agency to intensify its efforts to track and regulate overseas pharmaceutical manufacturing, we can expect the FDA to intensify its oversight even more," Rozembajgier noted.
The recall trend aligns with the rise in warning letters and Form 483 inspection reports, all signs of an FDA actively determined to enforce good manufacturing practices. The pharma section of the index is based on public information in FDA enforcement reports.
The index shows that 132 of the 150 recalls were national in scope. Sixteen were regional and two affected only countries outside the U.S. (55 were considered national and involved at least one other territory or country).
Less than 7% of the third-quarter recalls were designated Class 1 (potential for serious injury or death, according to US Recall News), according to the index; 60% were Class 2 (possibility of serious enough adverse events to have irreversible consequences); and 30% were Class 3 (not very likely to cause adverse health consequences).
- see the release
- here are the pharma stats (.pdf)
- see this graphical summary (.pdf)
- go here for the full report
- here are the US Recall News category definitions
Special Report: Fierce's 2011 warning letters report