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Was a defective drug designed or manufactured incorrectly?

by | Apr 27, 2018 | Defective Drugs |

Every time you visit your local pharmacy in The Woodlands, you likely assume that every medication it fills or stocks its shelves with is perfectly safe for you and others to use. That belief might be reaffirmed by you seeing the seal of approval from the U.S. Food and Drug Administration printed on the label. Yet simply because a drug is approved by the FDA does not necessarily mean that it is safe. How is that possible? 

When your adverse reaction to a drug is traced back to the drug itself, the underlying problem can typically be attributed to one of two issues: formulation errors or manufacturing errors. Formulation errors occur during a drug’s design, meaning that it is created improperly right from the start. Any interventions or follow-up action that occurs after its development cannot change the fact that it was formulated incorrectly. Manufacturing errors, on the other hand, occur when drug is properly developed, yet a problem occurs during the manufacturing process. Common drug manufacturing errors include: 

  • Contaminated samples
  • Labeling errors
  • Incorrect potencies 

Adverse reactions to both formulation and manufacturing are often similar. The major difference between the two is with a formulation error, your body is typically reacting to the drug itself, whereas with a manufacturing error, it is reacting to an incorrect amount of it. 

Understanding the nature of defective drugs prompts the question of how such medications are able to obtain FDA approval. Per the FDA’s website, manufacturers are the ones tasked with testing their drugs, not the FDA itself. This may account for formulation errors. Manufacturing errors are typically not related to FDA standards, but rather issues with a manufacturer’s own internal processes.