Hullverson Law Firm

FDA guidance aims to help Missouri patients

An analysis of data from the Institute of Medicine shows that up to 7,000 Americans die each year due to medication errors. However, new guidance from the FDA may begin to reduce that figure. The guidance is part of an ongoing effort to meet the goals of the Prescription Drug User Fee Act and aims to cut down on confusing packaging and medication names.

The first document asks all applicants and sponsors to provide extensive information related to the name of a medication. Information that the agency would like to see includes the intended pronunciation of a medication, alternate proprietary names as well as proposed labels. It also asks for information related to the dispensing and delivery of the medication. This may help prevent medications from looking or sounding too much like others already on the market.

A second document pertains to how an applicant or sponsor can make it easier for a patient to interpret the information provided. It also asks that they take setting into consideration when designing a medication package and label. For instance, design may need to be altered to meet the needs of a patient in a hospital compared to a patient taking medication at a home or at their own home.

Confusion in packaging or labeling can lead to a patient taking the wrong medication dosage, and this can lead to a worsened medical condition and other harm. This in some cases could be considered actionable negligence, and an attorney representing such a patient can review the evidence in order to determine the party or parties that should bear financial responsibility.

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