Violations of Good Manufacturing Practices

What are violations of Good Manufacturing Practices?

Drug makers are required to comply with manufacturing standards, known as “Good Manufacturing Practices” or “GMPs,” that ensure that their products are free from defects, degradation, or contamination.

When a government health care program covers prescription medication, it pays on the assumption that the drug has been manufactured in conformity with good manufacturing practices (GMP). Federal law enforced by the Food & Drug Administration requires that drug makers comply with manufacturing standards that ensure that their products will be free from defects, degradation and contamination. Without such a requirement, consumers would have no basis to trust that a drug is composed of the ingredients set forth on the label, that it has the represented strength, and that it is free from other defects and contamination. Payers, including government health care programs such as Medicare and Medicaid, likewise have the right to assume that they are paying for products manufactured in conformity with the law.

When a drug manufacturer is in gross violation of GMP, it may face significant liability under the False Claims Act on the ground that it is has not delivered the product for which the government paid — i.e., a product manufactured in conformity with the law. Indeed, in 2010, after extended litigation conducted by the whistleblower and her counsel, Glaxo Smith Kline (GSK) agreed to pay $750 million to resolve its criminal and civil liability under the False Claims Act for longstanding microorganism contamination, product mix-ups, and splitting tablets caused by faulty manufacturing problems at its plant in Cidra, Puerto Rico.

In assessing whether to bring a False Claims Act qui tam lawsuit based on a pharmaceutical company’s violation of GMP, it is important to consider the following questions:

  1. Does the GMP violation create a serious threat of product defect, degradation or contamination?
  2. Is there evidence that the violation has led to actual product defects, degradation or contamination?
  3. Is the GMP violation pervasive, either across operations or time?
  4. Did the company fail to remedy the problem despite knowing of the problem and having more than sufficient time to rectify it?
  5. Do documents corroborate the company’s knowledge of the GMP violations?
  6. Have government health care programs paid significant amounts of money for the affected drug products?