In April, the McNeil unit of Johnson & Johnson (J&J, New Brunswick, NJ) shut its flagship facility in Fort Washington, Pennsylvania, and recalled millions of bottles of children's cold medicines due to repeated failures to meet manufacturing standards and comply with regulations. The problems, observed FDA Principal Deputy Commissioner Joshua Sharfstein at a Congressional hearing in May, appear related to the company's "pattern of noncompliance" with quality control requirements. J&J now faces potentially serious legal issues, as Congressional leaders have raised charges of stonewalling, and FDA is examining whether the firm knowingly misled the regulators.
Meanwhile, Genzyme (Cambridge, MA) continued its struggle to restore production capacity after contamination problems prompted the closure of its Allston Landing, Massachusetts, facility in June 2009. The company paid a hefty fine and invested millions in plant cleaning and renovation. Manufacturing issues also compelled KV Pharmaceutical (St. Louis, MO) to shut down operations and recall multiple generic products and vitamin therapies. And several vaccine manufacturers are working hard to eliminate extraneous viruses from cell banks and to correct manufacturing issues identified by FDA inspectors.These situations raise questions about whether drug and biological manufacturers are cutting corners in their quality systems needed to comply with current good manufacturing practices (CGMPs). In 2002, FDA launched the Pharmaceutical CGMPs for the 21st Century initiative to modernize the regulation of drug manufacturing and to spur industry efforts to ensure product quality. After issuing several new policies and guidances to encourage a risk-based approach to quality control, FDA had to move the effort to the back burner as other issues, including these compliance crises, began to dominate the agency's agenda.
The current surge in manufacturing problems has placed drug quality and GMP compliance back in the spotlight at FDA. In a major speech last August (2009), FDA Commissioner Margaret Hamburg emphasized the importance of industry adherence to regulatory standards (see the October 2009 edition of Washington Report in Pharmaceutical Technology). Hamburg outlined initiatives to accelerate the correction of manufacturing violations identified during plant inspections and to streamline the process for issuing Warning Letters to companies that fail to address violations expeditiously.