EARLIER THIS YEAR, THE DEPARTMENT of Justice (“DOJ”) announced that it will be taking “an especially hard look” at violations of current good manufacturing practices (“cGMPs”) that create an unacceptable risk of harm to consumers and patients. 1 This was a clear pronouncement of the 2013 enforcement priorities of the Consumer Protection Branch of the DOJ’s Civil Division, and signals a developing enforcement trend in the pharmaceutical and medical device industries. Where cGMP compliance was once left almost wholly to the U.S. Food and Drug Administration (“FDA”) to enforce under the Federal Food, Drug, and Cosmetic Act (“FDCA” ), the DOJ plans to actively step up enforcement for cGMP violations under authority of the False Claims Act (“FCA”). 2

With limited exceptions, enforcement against cGMP violations has always occurredunderthe FDCAandFDA’s implementing regulations.  Specifically, the FDCAprohibits adulterated drugs and devices in interstate commerce. 3 A drug is “adulterated,” inpart, “ifthemethodsusedin, orthe facilities or controlsused for,itsmanufacture,processing,packing orholdingdonot conform to or are not operated or administered in conformity with  [cGMP] to assure that such drug meets the [statutory]requirements as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.” 4

Similarly, a device is “adulterated” if “the methods used in, orthe facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable [laws],” including the Quality System Regulation (“QSR”). 5 FDA regulations establish minimum cGMP/QSR requirements for many FDA-regulated products, including drugs and devices. 6 These requirements are not prescribed in detail, but were established “to be flexible to allow each manufacturer to decide individually how best to implement the necessary controls by using scientifically sound design, processing methods, and testing procedures.” 7

This flexibility allows companies to achieve higher quality through continual improvement, utilizing newer technology and innovation. Failure to comply with these basic standards renders a product adulterated underthe FDCA and subject to FDA enforcement action, which may range from a Warning Letter to product seizures, injunctions against manufacturing and distribution, import holds, civil monetary penalties, and criminal liability.