Justice Department Steps Up Focus on GMP Violations

Federal law enforcers are looking hard at pharmaceutical manufacturers that put consumers at risk by cutting corners on product quality and safety and violating current good manufacturing practices (cGMPs). The Department of Justice (DOJ) is “taking an especially hard look” at situations that compromise drug safety, identity and quality, explained DOJ deputy assistant attorney general Maame Ewusi-Mensah Frimpong at this week’s CBI Compliance Conference in Washington, D.C.

Manufacturers, she acknowledged, are under  “enormous pressures” to produce drugs “more quickly, cheaply and efficiently,” but that they can’t sacrifice drug safety in the process. As head of DOJ’s Consumer Protection Branch, Frimpong emphasized that violations of Food and Drug Administration requirements top its priority list –  along with its broad responsibilities for bringing civil and criminal charges for fraud and violations involving food, drugs, consumer goods, services and financial fraud.

To build strong compliance programs, Frimpong advised manufacturers to focus on people. That involves providing the training and expertise that employees need to recognize manufacturing problems; establishing “the right incentives” for people to detect, report and fix such problems; establishing realistic expectations for company staff; and making sure that management knows the organization, performs audits and keeps track of compliance “in a rigorous way.”

Frimpong noted that strong GMP enforcement action by DOJ not only protects consumers, but also benefits “those companies that do follow the rules.” Weak enforcement that encourages deviations from GMPs will erode the confidence of the American public in our drug system, she warned, and encourage consumers to look for medications outside the regulated market through illegal online pharmacies. “When companies put profits over safety, nobody wins,” she said, advising industry executives to “think creatively” about how to establish “a deep and effective culture of compliance within your organizations.”