Greater FDA inspection role increased drug recalls in Q3, study
The study, by waste management firm Stericycle, examined US Food and Drug Administration (FDA) enforcement reports for the three months ended September 30 and found that 150 were for withdrawals of pharmaceutical products, a 54 per cent increase on the 97 recalled in Q2.
Company VP of recalls Mike Rozembajgier told in-Pharmatechnologist.com that: “The number of drug recalls has increased steadily over the past five quarters, while the number of units has steadily decreased over the same period.
“In fact, recalls during the third quarter of 2011 affected 87 percent fewer units than recalls in the same quarter last year. Regardless of the number of units affected, the fact that more recalls are occurring is evidence that regulators are stepping up their scrutiny of both domestic and international pharmaceutical manufacturers.
Rozembajgier also forecast that pharmaceutical recalls will continue to increase over the medium term as US regulators are set to play a greater role in ensuring the quality of drug imports.
“While the FDA has already stepped up its oversight of US manufacturing plants and operations, the Government Accountability Office recently called on the agency to intensify its efforts to track and regulate overseas pharmaceutical manufacturing as well. We expect that the FDA will respond to these recommendations.
In February this year the GAO called on the FDA to create a workforce plan for overseas offices and adopt of a more risk-based inspection policy, reiterating the concerns it voiced in 2008.
Rozembajgier also predicted that, if passed next year, the proposed Generic Drug User Fees Act (GDUFA) would increase the number of pharmaceutical recalls given that it “would require foreign manufacturing plants to be inspected at the same frequency as domestic plants."
