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Discovering the cause of a drug's defect: drug manufacturers must follow good manufacturing practices when making their products. When a defective drug causes injury or death, documents showing how the drug was made are key to proving the defendant failed in its duty to consumers.

Article Excerpt
The Federal Food, Drug, and Cosmetic Act (FDCA) provides certain minimum standards that companies must meet when manufacturing drugs. (1) It identifies these standards as good manufacturing practices (GMPs). (2)

If a company fails to comply with the GMPs, the finished products are considered adulterated or misbranded. (3) The act prohibits the introduction of adulterated or misbranded products into interstate commerce. (4) Knowledge of the GMPs can aid in establishing whether a drug is adulterated or whether the defendant manufacturer was negligent in making it. (5)

The FDA is charged with monitoring drug companies' manufacturing practices and with administering and enforceing the FDCA. (6) The act does not allow private enforcement actions because of the possibility that such actions would duplicate state law remedies. (7) However, an FDCA violation may serve as an element of a state products liability action. (8) Violation of safety regulations and statutes provides a basis for state law negligence claims. (9)

When a pharmaceutical company decides to market a new drug, in addition to ensuring that its proposed manufacturing procedures comply with GMPs, it must also submit its own proposed procedures for a specific drug's manufacture, including testing methods and validations of the proposed procedures and tests.

These procedures are submitted to the FDA for approval in New Drug Applications (NDAs); for generic drugs, the procedures are listed in Abbreviated New Drug Applications (ANDAs). Neither application supersedes the published GMPs, which ensures that drugs meet the act's safety requirements and have the ingredients, strength, quality, and purity that they purport to possess. (10)

The FDA uses the testing and validation data to determine whether a company's procedures are eligible for approval. Once procedures are approved, a company must strictly comply with them, including the testing protocols; no changes to the procedures or testing protocols without prior FDA approval are permitted.

The FDA's regulation of the manufacture of prescription drugs is generally viewed as a minimum standard. (11) The FDA's acceptance of submitted procedures is evidence, not conclusive proof, of the reasonableness of the company's manufacturing practices and procedures, and the trier of fact may assign FDA approval the weight it deserves. (12)

FDA approval to manufacture and market a drug is contingent on the drug company's production and testing of the product according to approved procedures. Failure to fully comply with these procedures constitutes a failure to meet minimum standards and violates the approval. If the patient takes a drug as directed and experiences an injury that the drug was promoted to prevent or has suffered an unlabeled adverse event, the manufacture of the product may be relevant.

In U.S. v. Barr Laboratories, Inc., the initial drug testing that Barr performed in accordance with the approved GMPs found that some drugs were "out of specification" because they did not meet the specifications described in the U.S. Pharmacopeia (USP) or the ANDA. (13) The results occurred because of laboratory, operator, and manufacturing errors. (14)

Barr's laboratory testing results reporting that the batches were "out of specification" should have triggered a well-documented failure investigation to determine...

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