The Law Offices of John Phebus

FDA issues final guidance about drug names and packaging

Arizona patients are sometimes harmed by medications due to confusion over the drug's name or packaging design. The results can be very serious, and the Institute of Medicine claims that around 7,000 people in the U.S. die each year as a result of medication errors. To reduce the risk of fatal medication mistakes, the U.S. Food and Drug Administration has issued two final guidance documents.

The first final guidance document that was issued by the FDA concerns proprietary names for medications. The FDA has asked drug manufacturers to include several pieces of information about the proprietary name of a drug in their submissions for approval. Some of the information that must now be written in an FDA application includes an alternative proposed proprietary name, the intended meaning of the modifiers in the name and the intended pronunciation.

In the FDA's second final guidance document, drug manufacturers were told to consider the potential for medication errors while designing a drug's packaging. Drug packaging, referred to by the FDA as the 'user interface," is responsible for helping a patient interpret crucial drug information like drug strength and recommended dosage. The FDA says that a drug's final dosage should be taken into account early in the packaging design process.

A confusing packaging design could result in a patient taking an incorrect dosage of a prescription drug. This could lead to a worsened medical condition requiring additional and expensive medical care and treatment. In such cases, an injured victim may want to meet with an attorney in order to determine what recourse, if any, is available for seeking compensation for those and other losses.

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