Pharmaceutical companies defrauding the government by manufacturing adulterated pharmaceuticals have often gone to great lengths to thwart FDA inspections of their sites.
But Japanese drug maker Nippon Fine Chemical took those efforts to a new level last December when a supervisor ordered employees to physically block an FDA agent from inspecting its plant in Takasago City, Japan.
The FDA said it had received complaints that Nippon’s drugs contained glass, hair, cardboard, metal, product discoloration and a black spider.
When an FDA inspector tried to enter the quality control laboratory, Nippon’s quality control manager “directed employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and equipment used to analyze drugs for U.S. inspection,” according to the FDA. The FDA also noted that Nippon refused to provide copies of documents and prevented the investigator from photographing manufacturing equipment.
While companies often try to cover up their fraud, few have gone so far as to physically bar authorities from entering their premises in an investigation. More often, companies that have attempted to hide fraudulent actions do so by delaying inspections, destroying or changing documents, and lying to federal agents.
Despite Nippon’s extreme actions, the FDA has yet to levy any fines on the company or bar its products from entering the US. The FDA has only issued a warning letter and placed Nippon on Import Alert. As a result, Nippon products entering the US can be detained, and the FDA can recommend withholding applications for new products made by Nippon.
But so far, Nippon does not seem to have suffered any real consequences for its actions.
While the FDA’s lackluster response is concerning, there are other means that have proven effective to stop adulterated drugs from entering the pharmaceutical supply chain – whistleblower lawsuits chief among them.
In 2010, as a result of a whistleblower case, GlaxoSmithKline paid $750 million in criminal and civil fines for producing adulterated drugs at its plant in Puerto Rico and distributing them. GlaxoSmithKline pleaded guilty to felony charges of violating the US Food, Drug and Cosmetic Act, and agreed to a civil settlement under the False Claims Act. As part of that investigation, the FDA seized all stocks of certain drugs and placed the plant under a consent decree with independent monitoring of products. The plant closed before the settlement was announced.
In 2013, Indian drug manufacturer Ranbaxy paid $500 million in civil and criminal fines after a whistleblower exposed the company’s production of adulterated drugs at its plants in India. Drugs from two factories stopped being shipped in 2008 as part of the investigation. In addition to paying a large settlement under the False Claims Act, Ranbaxy pleaded guilty to multiple felony charges and was placed under a consent decree.
Although it’s unknown what future steps the FDA might take to deal with Nippon, pharmaceutical company employees who see manufacturing conditions that hurt the quality of pharmaceutical products should know that working with an attorney to file a “qui tam” (whistleblower) lawsuit under the US False Claims Act can be a very effective way to protect patients and hold accountable any company that produces adulterated pharmaceuticals used in the US.