Good Manufaturing Practices

Pharmaceutical companies must comply with “Good Manufacturing Practice” (GMP) regulations. These regulations, promulgated and enforced by the FDA, ensure that a drug is safe for use and not adulterated or defective in any manner. The GMP regulations “contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug.”

Pharmaceutical companies that do not comply with the GMP regulations and sell adulterated drugs will be in violation of the Federal Food, Drug and Cosmetic Act, and can face criminal penalties. Furthermore, companies that knowingly fail to comply with GMP regulations may be in violation of the False Claims Act if false claims for payment were submitted to programs like Medicare, Medicaid, and TRICARE, for the adulterated drugs.

Real World Examples of Recent Good Manufacturing Practices Violation Fraud False Claims Act Cases:

  • 2010: A subsidiary of GlaxoSmithKline, PLC paid $600 million to settle False Claims Act and state law claims stemming from a whistleblower lawsuit brought by a former employee. The whistleblower asserted that the company sold drugs that were significantly below the quality of that specified in documents submitted to the FDA and, thus, knowingly cause the submission of false claims to government health care programs. Specifically, it was alleged that GlaxoSmithKline failed to make certain that drugs were free from contamination, had defects in manufacturing that caused tablets to split which rendered them ineffective, commingled different types of drugs, and did not always produce drugs that contained the correct mix of active ingredients as dictated by the FDA. As a result of the settlement, the former employee whistleblower received over $96 million.

For a free consultation about a potential Good Manufacturing Practices violation case, pharmaceutical fraud, or other potential whistleblower case, please call us or click here to submit your information.