Medical product makers should be advised that FDA is planning to aggressively recommend misdemeanor prosecutions against responsible corporate executives for good manufacturing procedures (GMP) violations based on authority granted by the US Supreme Court in 1975, FDA deputy chief counsel for litigation Eric Blumberg told a Food and Drug Law Institute enforcement roundtable in April.
“Corporate officials should not be waiting for Warning Letters before addressing GMP issues at their firms,” he cautioned.
“This is not a negligence standard, but a strict liability standard, and so tell your clients to pay attention to their GMP reports and other information that is coming up to them,” Blumberg told his audience.
Increasing misdemeanor prosecutions was urged by a GAO report in March, which FDA commissioner Margaret Hamburg cited as part of her aggressive enforcement posture. In a letter to activist Senator Charles Grassley (R-IA), she said “criteria have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions.”