FDA Cracks Down on Drug Manufacturing
The FDA is "scrambling" to "crack down" on pharmaceutical companies engaging in "sloppy manufacturing practices," the Newark Star-Ledger reports. Over the past 16 months, the FDA has issued a number of penalties for drug companies that fail to comply with the agency's manufacturing regulations, including imposing "some of the stiffest fines in [FDA] history," suspending manufacturing operations and issuing "pointed warnings" to a number of drug makers that have "ignored" previous FDA citations. The FDA issues warnings and penalties for a number of reasons, including failure to validate procedures or to meet the agency's production standards, a lack of documentation and improper maintenance of equipment. Recently, Abbott Laboratories, American Home Products and Schering-Plough Corp. all have faced sanctions or fines by the FDA for not passing agency inspections.
Jim Dickinson, editor of the industry newsletter Dickinson's FDA Review, said the FDA has not been able to hire enough new inspectors to "properly" monitor manufacturing, and FDA officials "believe the could be doing much more to ensure manufacturing quality." According to FDA spokesperson Susan Cruzan, the number of inspections fell by 14% last year, and the agency is currently trying to focus on "cases with a bigger impact," which include plants with "the most risky products," companies with a history of noncompliance and facilities making newly approved drugs. Dickinson added, "Top FDA people are beginning to think they're losing control of the brand-name drug makers." The Star-Ledger reports that the penalties and warnings "go to the heart" of the drug industry's tendency to give a low priority to manufacturing operations. Jami Rubin, a pharmaceutical analyst with Morgan Stanley Dean Witter, said, "Manufacturing has never been a primary concern to the industry. Research comes first, marketing second and manufacturing third" (Silverman/Cohen, Newark Star-Ledger, 3/19).